Investigations Lead
Vor 2 Tagen
Jobdescription For more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in Switzerland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Position overview The Non-conformance Investigator position in MSIT aims to follow the overall process of non-conformance investigations, based on Johnson & Johnson requirements. The investigator will be responsible for the E2E investigation process: initiation, lead and writing of impact assessment, leading execution of the investigation of Medium/High Impact Non-conformances, aiming at the identification of assignable and/or root cause, as well as implementation of corrections, Corrective and/or Preventive Actions to prevent Recurrence, and effectiveness check. Main Responsibilities: Independently lead non-conformance issuance, performance of impact assessment and respective investigation to prevent recurrences in support of Manufacturing operations. Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the non-conformance investigation, identification of Corrections and Corrective and Preventative Actions to reduce or prevent recurrence. Routine interaction with the Operations, Quality Control, Quality, Assurance, and other departments to communicate investigational status, perform alignment meetings, facilitate reviews, CAPA discussions and comments resolution. Technical writing of investigation reports for the educated but uninformed reader, that accurately capture immediate actions and containment of the event, conclusion on the cause of the non-conformance and follow-up actions to prevent recurrence. Work on the manufacturing floor together with other SMEs for data gathering, observing processes for investigations, and performance of associated interviews (e. g. operators). Meeting Facilitation and participation, aligning both internal and quality review team and the area subject matter experts on an agreed investigational path forward. Management of multiple quality investigation projects and timelines concurrently. Ability to adhere to standard timelines and escalate actions appropriately for resolution in a timely manner. Work as an SME in the corresponding team on assigned tasks and processes other than the assigned investigational lead. Input on validation and qualification assessments Present in investigations during audits/health authorities' inspections. Qualifikationen Who we are looking for: Bachelor or advanced degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience. 3+ years background in biopharma production environment regulated by cGMP standards, preferably in manufacturing operations and/or Quality Control. Skilled in supporting pharma process investigations, experienced in Root Cause Analysis tools (e.g. 5 Why, Fishbone, Kepner-Tregoe) and technical writing. Analytical thinking and problem-solving attitude combined with good teamwork capabilities Good complex conflict resolution, problem solving in a cross functional setting. Ideally certified 'Green' or 'Black' belt lean-six sigma. Experience in project lead Excel in a quality driven organization Can prioritize multiple assignments and changing priorities. Language Requirements: Proficiency in English is required. German language skills are desirable but not mandatory This job based in Bern, Switzerland will initially be limited to approx. 12 months. If you are interested in working with a global leading pharmaceutical company in a dynamic, progressive, and collaborative environment, then send us your application today. Or give us a call if you have any questions
-
Investigations Lead
vor 1 Tag
Bern, Schweiz Randstad VollzeitJobdescription For more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that...
-
Investigations Lead
vor 2 Wochen
Bern, Schweiz Randstad (Schweiz) AG VollzeitJob DescriptionFor more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.We know that the success of our business depends on having the best talent in a workforce that...
-
Manager, Investigations
vor 7 Monaten
Bern, Schweiz Johnson & Johnson VollzeitJohnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a **Manager, Investigations, to join MSIT (Manufacturing Science and Innovation Technology) team in Bern, Switzerland.** Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science...
-
Bern, Schweiz Recrutis VollzeitFor one of our clients, a leading Worldwide Biotech company in Bern area, we are currently looking for aManufacturing Sciences Upstream Process Technology LeadJOB PURPOSE:As a key leader in Upstream Process Technologies, you join the Global Manufacturing Sciences Department at the Drug Substance biologics manufacturing site to oversee all USP Process...
-
Cq Execution Lead
vor 7 Monaten
Bern, Schweiz Project Delivery Partners VollzeitCQ Execution Lead **Job Description**: **Job Summary** The CQ Execution Lead is responsible for supporting the planning, execution and supervision of the entire Project Commissioning and Qualification field activities. To support meeting the agreed objectives regarding schedule and functionality according to URS, GMP, Safety and environmental...
-
Bern, Schweiz CSL Behring VollzeitAs a Drug Product (DP) External Manufacturing Lead you will be responsible for providing process engineering support for all DP manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be accountable for establishing and managing key process performance indicators across multiple CMOs, products and...
-
Process Engineering Head, Bern and Gti Lead
Vor 6 Tagen
Bern, Schweiz CSL Behring VollzeitThe process engineering site lead is accountable to lead the process engineering teams on site: supporting day-to-day business with process engineering and scientific knowledge and resources; focused on site execution and support; site point of contact for engineering, focused on process, system and technologies. S(he) is accountable for execution of all...
-
Cq Execution Lead
vor 7 Monaten
Bern, Schweiz Project Delivery Partners Vollzeit**Job Summary** The CQ Execution Lead is responsible for supporting the planning, execution and supervision of the entire Project Commissioning and Qualification field activities. To support meeting the agreed objectives regarding schedule and functionality according to URS, GMP, Safety and environmental objectives. **Main responsibilities** Main...
-
Clinical Research Associate Senior Lead
vor 2 Wochen
Bern, Bern, Schweiz Pharmiweb VollzeitPharmiweb is a pioneering Med Tech company developing innovative structural heart valves.About the RoleWe seek a highly motivated and results-oriented Clinical Research Associate Senior Lead to join our growing team in Europe. The ideal candidate will oversee daily operations at investigational sites, ensuring compliance with international guidelines, local...
-
Biotechnology Manufacturing Process Lead
vor 2 Wochen
Bern, Bern, Schweiz Gi Life Sciences VollzeitJob DescriptionWe are seeking a highly skilled Manufacturing Engineer to join our team at Gi Life Sciences.This temporary position will play a crucial role in the operational readiness of new product introduction and daily support of the manufacturing area.Main Responsibilities:Schedule daily operational activities, including material staging and equipment...
-
Regional Employee Relations Lead, Emea
vor 2 Wochen
Bern, Schweiz CSL Behring VollzeitResponsibilities: **1. EMPLOYEE/INDUSTRIAL RELATIONS** - Manage and develop a high performing team of Employee Relations staff members and oversee their ER case management. Supervise that their staff members are meeting all compliance and process requirements, i.e., case selection, time to close, recording and documentation in systems, managing risk and...
-
Bern, Bern, Schweiz CSL Behring AG VollzeitAs a Process Engineering Lead for External Manufacturing Operations, you will be responsible for providing process engineering support for all Drug Product manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be accountable for establishing and managing key process performance indicators across...
-
Bern, Schweiz CSL Behring AG VollzeitAs a Drug Product (DP) External Manufacturing Lead you will be responsible for providing process engineering support for all DP manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be accountable for establishing and managing key process performance indicators across multiple CMOs, products and...
-
Bern, Schweiz CSL Behring AG VollzeitAs a Drug Product (DP) External Manufacturing Lead you will be responsible for providing process engineering support for all DP manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be accountable for establishing and managing key process performance indicators across multiple CMOs, products and...
-
Bern, Schweiz CSL Behring AG VollzeitAs a Drug Product (DP) External Manufacturing Lead you will be responsible for providing process engineering support for all DP manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be accountable for establishing and managing key process performance indicators across multiple CMOs, products and...
-
Bern, Schweiz CSL Behring AG VollzeitAs a Drug Product (DP) External Manufacturing Lead you will be responsible for providing process engineering support for all DP manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be accountable for establishing and managing key process performance indicators across multiple CMOs, products and...
-
Enterprise Data Management Lead
vor 2 Wochen
Bern, Schweiz CSL Behring VollzeitResponsibilities: - Facilitate the establishment and execution of the roadmap for EDM, including governance frameworks, data quality standards, and strategy. - Contribute to the overall strategic direction in elevating the data management maturity in support of the company’s strategy and setting standards and guidelines. - Collaborate cross-functionally...
-
Manufacturing Sciences Upstream Process Technology
vor 7 Monaten
Bern, Schweiz Recrutis VollzeitFor one of our clients, a leading Worldwide Biotech company in Bern area, we are currently looking for a **Manufacturing Sciences Upstream Process Technology Lead** **_ JOB PURPOSE:_** As a key leader in Upstream Process Technologies you join the Global Manufacturing Sciences Department at the Drug Substance biologics manufacturing site to oversee all USP...
-
Process Lead Quality Management
vor 7 Monaten
Bern, Schweiz CSL Behring Vollzeit**Responsibilities**: **Quality Management Processes** - Represent and own the global Quality / EBR processes for all Manufacturing Sites and Affiliates. - Manage a team of Manager Level Professionals to ensure continuous process improvements and adherence to Global Standards. - Ensure full compliance with Quality Requirements of Regulatory Agencies and...
-
QC Lab Team Leader
Vor 4 Tagen
Bern, Schweiz Pro Resources Staffing Services Vollzeit2024-10-02 2024-11-02 Industry: Industrial Job Number: CJ935366102 Pay Rate: $45000-50000 / year Branch: Clerical & ProfessionalJob DescriptionPro Resources Professional is currently seeking a qualified QC Lab Team Leader to join our client's dynamic team in Berne, IN. This position offers the opportunity to lead and develop a dedicated team...
