Senior Specialist Quality Assurance

vor 2 Wochen

Schachen LU, Luzern, Schweiz MSD Vollzeit

Job Description

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

The Senior Quality Specialist, Quality Operations reports to the Associate Director, Quality Assurance (QA) Operation Schachen Biologics and supports clinical quality activities at our Werthenstein site. Being accountable for Good Manufacturing Practice (GMP) compliance, ensuring clinical supply functions operate within GMP requirements and compliant clinical drug substance and drug product supply. Driving and supporting compliance-based programs and results which includes supporting or leading cross functional projects, solving complex problems, current Good Manufacturing Practices (cGMP) quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, Standard Operating Procedure (SOP) management, and site procedures.

Responsibilities:

  • Apply critical decision making, project management skills.
  • Provide guidance, consulting, interpretation of GMP and regulatory requirements or standards.
  • Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory, etc. at all levels.
  • Review and approval of relevant master batch records, Bill of Materials (BOMs), and recipes.
  • Review and approval of process risk assessments as appropriate.
  • Participate and direct quality-on-the-floor initiative (shopfloor).
  • Support drug product manufacturing (sterile filling) operations.
  • Ensure deviations are investigated and resolved (within quality as well as functional areas). Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
  • Support, review and approve as needed the change management program (Change Control).
  • Provide guidance and support on equipment qualification, System Development Life Cycle (SDLC), raw material release activities, environmental monitoring, as well as support of utilities functions.
  • Perform SOP review and approval within Quality and for functional area procedures.
  • Participate in the release or rejection of GMP materials and components either through direct batch release support or involvement with critical program issues.
  • Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance.

Additional Skills and Competencies considered a strong asset:

  • Experience and in-depth knowledge of fully integrated, automated and recipe driven operation e.g. DeltaV, SAP, MES.
  • Experience in drug product filling and inspection practices.Fluent in English and German.

Your Profile:

  • A Master's Degree in Engineering, Sciences or related field and at least five (5) years of experience in the pharmaceutical, biotech or another regulated industry.
  • Experience with formal problem-solving techniques and a hands-on approach to problem solving, such as Root Cause Analysis and/or Lean Six Sigma tools.
  • cGMP experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment.
  • Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification.
  • Experience in pharmaceutical, biotech or other regulated industry.
  • Technical writing experience, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols.
  • Ability to conduct multiple investigations within established deadlines.
  • Demonstrated ability to manage multiple projects and initiatives.

THE COMPANY

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company's medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness. We are proud to be certified as a "Top Employer Switzerland" and "Top Employer Europe" showing the company's commitment to our employees and the community around us.

Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/6/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:06/06/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R293293

  • Specialist Clinical Supplies Quality Assurance

    Vor 3 Tagen

    Schachen LU, Luzern, Schweiz MSD Vollzeit

    Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...

  • Senior Specialist QA

    vor 3 Wochen

    Schachen LU, Luzern, Schweiz MSD Vollzeit

    Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...

  • Senior Specialist QA

    vor 2 Wochen

    Schachen LU, Luzern, Schweiz MSD Vollzeit

    Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...

  • Senior Specialist Tech Transfer

    vor 3 Wochen

    Schachen LU, Luzern, Schweiz MSD Vollzeit

    Job DescriptionAs a member of the growing BPRnD at our Company, you will be responsible for the ensuring and supporting a fast and efficient Tech Transfer from development area to clinical manufacturing and from early clinical manufacturing to late Phase manufacturing to keep our Company at the forefront of clinical manufacturing of biologics.The Senior...

  • Senior Specialist Tech Transfer

    vor 2 Wochen

    Schachen LU, Luzern, Schweiz MSD Vollzeit

    Job DescriptionAs a member of the growing BPRnD at our Company, you will be responsible for the ensuring and supporting a fast and efficient Tech Transfer from development area to clinical manufacturing and from early clinical manufacturing to late Phase manufacturing to keep our Company at the forefront of clinical manufacturing of biologics.The Senior...

  • Employee Quality Assurance 50 %

    vor 3 Wochen

    Aesch LU, Luzern, Schweiz Essemtec AG Vollzeit

    Ihre Fähigkeiten entfaltenHerzlich Willkommen bei Essemtec Die Tier- und Pflanzenwelt zeigt uns immer wieder, mit welch atemberaubender Anpassungsfähigkeit die Natur sich auf verschiedenste Anforderungen der Umwelt einstellen kann. Das inspiriert uns Die Essemtec AG ist ein Technologieunternehmen mit Entwicklungs- und Produktionsstandort in der...

  • Employee Quality Assurance 50 %

    vor 2 Wochen

    Aesch LU, Luzern, Schweiz Essemtec AG Vollzeit

    Ihre Fähigkeiten entfaltenHerzlich Willkommen bei Essemtec Die Tier- und Pflanzenwelt zeigt uns immer wieder, mit welch atemberaubender Anpassungsfähigkeit die Natur sich auf verschiedenste Anforderungen der Umwelt einstellen kann. Das inspiriert uns Die Essemtec AG ist ein Technologieunternehmen mit Entwicklungs- und Produktionsstandort in der...

  • Algorithm Senior Software Engineer

    vor 2 Wochen

    Aesch LU, Luzern, Schweiz Essemtec AG Vollzeit

    Unfold Your SkillsEssemtec AG, a division of Nano Dimension, is a leading technology company that develops, produces, and distributes high-tech solutions for electronics manufacturing worldwide. Essemtec solutions are unique in the industry and are characterized by fast and uncomplicated adaptation to customer requirements.To support our team in Aesch LU...

  • Algorithm Senior Software Engineer

    vor 2 Monaten

    Aesch LU, Luzern, Schweiz Essemtec AG Vollzeit

    Unfold Your SkillsEssemtec AG, a division of Nano Dimension, is a leading technology company that develops, produces, and distributes high-tech solutions for electronics manufacturing worldwide. Essemtec solutions are unique in the industry and are characterized by fast and uncomplicated adaptation to customer requirements.To support our team in Aesch LU...

  • Algorithm Senior Software Engineer

    vor 1 Monat

    Aesch LU, Luzern, Schweiz Essemtec AG Vollzeit

    Unfold Your SkillsEssemtec AG, a division of Nano Dimension, is a leading technology company that develops, produces, and distributes high-tech solutions for electronics manufacturing worldwide. Essemtec solutions are unique in the industry and are characterized by fast and uncomplicated adaptation to customer requirements.To support our team in Aesch LU...

  • Senior Software Development Engineer

    vor 2 Wochen

    Aesch LU, Luzern, Schweiz Essemtec AG Vollzeit

    Unfold Your SkillsEssemtec AG, a division of Nano Dimension, is a leading technology company that develops, produces, and distributes high-tech solutions for electronics manufacturing worldwide. Essemtec solutions are unique in the industry and are characterized by fast and uncomplicated adaptation to customer requirements.To support our team in Aesch LU...

  • Senior Software Development Engineer

    vor 2 Wochen

    Aesch LU, Luzern, Schweiz Essemtec AG Vollzeit

    Unfold Your SkillsEssemtec AG, a division of Nano Dimension, is a leading technology company that develops, produces, and distributes high-tech solutions for electronics manufacturing worldwide. Essemtec solutions are unique in the industry and are characterized by fast and uncomplicated adaptation to customer requirements.To support our team in Aesch LU...

  • Senior Software Development Engineer

    vor 1 Monat

    Aesch LU, Luzern, Schweiz Essemtec AG Vollzeit

    Unfold Your SkillsEssemtec AG, a division of Nano Dimension, is a leading technology company that develops, produces, and distributes high-tech solutions for electronics manufacturing worldwide. Essemtec solutions are unique in the industry and are characterized by fast and uncomplicated adaptation to customer requirements.To support our team in Aesch LU...

  • Senior Software Development Engineer

    vor 2 Monaten

    Aesch LU, Luzern, Schweiz Essemtec AG Vollzeit

    Unfold Your SkillsEssemtec AG, a division of Nano Dimension, is a leading technology company that develops, produces, and distributes high-tech solutions for electronics manufacturing worldwide. Essemtec solutions are unique in the industry and are characterized by fast and uncomplicated adaptation to customer requirements.To support our team in Aesch LU...

  • Senior Specialist Quality Assurance

    vor 3 Wochen

    Schachen, Schweiz MSD Vollzeit

    Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...

  • Senior Specialist Quality Assurance

    vor 2 Wochen

    Schachen, Schweiz MSD Vollzeit

    Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...

  • Specialist Clinical Supplies Quality Assurance

    Vor 4 Tagen

    Schachen, Schweiz MSD Vollzeit

    Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...

  • Associate Director, Quality Assurance

    vor 1 Woche

    Schachen, Schweiz MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...

  • Senior Specialist QA

    vor 3 Wochen

    Schachen, Schweiz MSD Vollzeit

    Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...

  • Employee Quality Assurance 50 %

    Vor 4 Tagen

    Aesch LU, Schweiz Nano Dimension Vollzeit

    Essemtec AG, eine Division von Nano Dimension, ist ein führendes Technologieunternehmen, welches High-Tech Lösungen für die Elektronikfertigung entwickelt, produziert und weltweit vertreibt. Kerngeschäfte des Unternehmens sind hochflexible SMT-Bestückungssysteme, ausgeklügelte Dosieranlagen und intelligente Lager - und Logistiksysteme zur Optimierung...

  • Senior Specialist Tech Transfer

    vor 3 Wochen

    Schachen, Schweiz MSD Vollzeit

    Job DescriptionAs a member of the growing BPRnD at our Company, you will be responsible for the ensuring and supporting a fast and efficient Tech Transfer from development area to clinical manufacturing and from early clinical manufacturing to late Phase manufacturing to keep our Company at the forefront of clinical manufacturing of biologics.The Senior...

  • Senior Specialist Tech Transfer

    vor 2 Wochen

    Schachen, Schweiz MSD Vollzeit

    Job DescriptionAs a member of the growing BPRnD at our Company, you will be responsible for the ensuring and supporting a fast and efficient Tech Transfer from development area to clinical manufacturing and from early clinical manufacturing to late Phase manufacturing to keep our Company at the forefront of clinical manufacturing of biologics.The Senior...

  • Associate Director, Quality Biologics Development

    vor 2 Wochen

    Schachen, Schweiz MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...

  • Associate Director, Clinical Supplies Quality

    vor 2 Monaten

    Schachen, Schweiz MSD Vollzeit

    Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. The...

  • Associate Director, Clinical Supplies Quality

    vor 5 Stunden

    Schachen, Schweiz MSD Vollzeit

    Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. The...

  • Director, External Capabilities

    vor 2 Wochen

    Schachen, Schweiz MSD Vollzeit

    The Analytical Research & Development (AR&D) Compliance Center of Excellence (CoE) department of our Our Research Laboratories Division is seeking applicants for a director leading an analytical metrology and validation team at our European research facilities in Dunboyne, Ireland and Werthenstein, Switzerland. The External Capabilities & Compliance...

  • Senior Software Development Engineer

    vor 2 Monaten

    Aesch LU, Schweiz Essemtec AG Vollzeit

    Your contribution:Collaborate with and help lead a team of software engineersWork closely with cross-functional teams to define software requirements, specifications, and project timelines for Pick and Place and Dispenser, as well as Management Software and Industry 4.0 environments.Take ownership of and develop new market-differentiating features for touch...

  • Senior Software Development Engineer

    vor 2 Monaten

    Aesch LU, Schweiz Essemtec AG Vollzeit

    Your contribution:Collaborate with and help lead a team of software engineersWork closely with cross-functional teams to define software requirements, specifications, and project timelines for Pick and Place and Dispenser, as well as Management Software and Industry 4.0 environments.Take ownership of and develop new market-differentiating features for touch...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Sempach LU, Schweiz B. Braun Medical AG Vollzeit

    Regulatory Affairs Manager (f/m/d) The Global Regulatory Affairs department of the B. Braun Avitum division has an opportunity for a Regulatory Affairs Manager located at our site in Sempach, Switzerland. In our plant in Sempach, we develop and produce a broad range of products for cleaning and disinfecting instruments, biocidal products for hand and...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Sempach LU, Schweiz B. Braun Medical AG Vollzeit

    Regulatory Affairs Manager (f/m/d) The Global Regulatory Affairs department of the B. Braun Avitum division has an opportunity for a Regulatory Affairs Manager located at our site in Sempach, Switzerland. In our plant in Sempach, we develop and produce a broad range of products for cleaning and disinfecting instruments, biocidal products for hand and...

  • Director Operations Components EMEA

    vor 3 Wochen

    Luzern LU, Schweiz Schurter AG Vollzeit

    SCHURTER is looking for a new team member of his leadership team in EMEA with customer focus. In this role you will set the direction for the R&D Team and make sure they deliver the innovation goals together with the business team. As part of the leadership team we offer you different development opportunities. Your challenges Lead and oversee operations...