Investigations Lead

Vor 2 Tagen

Bern, Schweiz Randstad Staffing Vollzeit

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 7 Tagen

    Bern, Schweiz Randstad Vollzeit

    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...

  • Investigations Lead

    Vor 7 Tagen

    Bern, Schweiz Randstad Vollzeit

    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...

  • Investigations Lead

    vor 1 Tag

    Bern, Schweiz Randstad Vollzeit

    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...

  • Investigations Lead

    vor 1 Tag

    Bern, Bern, Schweiz Randstad Vollzeit

    Job OverviewThe Non-conformance Investigator position is responsible for leading the investigation process from initiation to completion, following Johnson & Johnson requirements. The investigator will gather data from various sources, perform Root Cause Analysis (RCA) to determine the most likely cause of the non-conformance investigation, and implement...

  • Quality Assurance Lead

    Vor 5 Tagen

    Bern, Bern, Schweiz Randstad Vollzeit

    Job OverviewThe Non-conformance Investigator role within MSIT is centered around following Johnson & Johnson's process for non-conformance investigations. The investigator will be responsible for leading the E2E investigation process: initiation, writing of impact assessments, execution of medium/high-impact non-conformances, and implementation of...

  • Quality Investigation Specialist

    vor 1 Tag

    Bern, Bern, Schweiz Randstad (Switzerland) Ltd. Vollzeit

    Required Skills and Qualifications- 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...

  • Investigations Lead: Director of Quality Assurance

    Vor 3 Tagen

    Bern, Bern, Schweiz Randstad Vollzeit

    At Johnson & Johnson, we are committed to fostering an inclusive environment where diverse backgrounds, perspectives, and experiences are valued. As a Non-conformance Investigator in our Manufacturing Supply and Technology (MSIT) department, you will play a critical role in ensuring the quality of our products.Key Responsibilities:Lead non-conformance...

  • Non-Conformance Resolution Lead

    Vor 2 Tagen

    Bern, Bern, Schweiz Randstad (Switzerland) Ltd. Vollzeit

    Job DescriptionThe 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 leading the E2E investigation process: initiation, lead and writing of impact assessment, execution of the investigation of Medium/High Impact...

  • Manufacturing Sciences Upstream Process Technology Lead

    vor 1 Woche

    Bern, Schweiz Recrutis Vollzeit

    For 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...

  • Process Engineering Lead, Drug Product External Manufacturing Operations

    Vor 3 Tagen

    Bern, Schweiz CSL Behring AG Vollzeit

    As 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...

  • Qcat Lead Scientist, Microbiology

    Vor 7 Tagen

    Bern, Schweiz CSL Behring Vollzeit

    The Quality Control (QC) function at CSL Behring is currently recruiting for a QC Analytical Technology (QCAT) Lead Scientist, Microbiology to join our dynamic global team based at our Kankakee site. Taking a leadership role within the team, as the QCAT Lead Scientist, Microbiology you provide technical expertise and are flexible to adapt in a volatile...

  • Senior Quality Engineer

    Vor 6 Tagen

    Bern, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career NetworkCTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.Senior Quality Engineer (German-speaking)Our client, a dynamic...

  • Senior Quality Engineer

    Vor 2 Tagen

    Bern, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career NetworkCTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.Senior Quality Engineer (German-speaking)Our client, a dynamic...

  • Regional Security Director EMEA

    Vor 3 Tagen

    Bern, Schweiz CSL Behring AG Vollzeit

    The Regional Security Director will oversee all security operations across the region, ensuring the safety of personnel, assets, and facilities. Reporting to the Head of Enterprise Security (CSO) and WREF, this role is responsible for developing and implementing security strategies, policies, and programs. The position ensures continuous, effective security...

  • Regional Security Director Emea

    Vor 3 Tagen

    Bern, Schweiz CSL Behring AG Vollzeit

    The Regional Security Director will oversee all security operations across the region, ensuring the safety of personnel, assets, and facilities. Reporting to the Head of Enterprise Security (CSO) and WREF, this role is responsible for developing and implementing security strategies, policies, and programs. The position ensures continuous, effective security...

  • Regional Security Director EMEA

    Vor 3 Tagen

    Bern, Schweiz CSL Plasma Inc. Vollzeit

    Regional Security Director EMEACSL Behring is a global leader in biotherapeutics, driven by our promise to save lives. At our Bern site, over 1,800 dedicated employees work together to develop and deliver life-saving therapies for patients with rare and serious medical conditions around the world.We are enthusiastic to expand our team and are currently...

  • Regional Security Director EMEA

    Vor 3 Tagen

    Bern, Schweiz CSL Behring AG Vollzeit

    CSL Behring is a global leader in biotherapeutics, driven by our promise to save lives. At our Bern site, over 1,800 dedicated employees work together to develop and deliver life-saving therapies for patients with rare and serious medical conditions around the world.We are enthusiastic to expand our team and are currently looking for aThe Regional Security...

  • Regional Security Director EMEA

    Vor 2 Tagen

    Bern, Schweiz CSL Vollzeit

    CSL Behring is a global leader in biotherapeutics, driven by our promise to save lives. At our Bern site, over 1,800 dedicated employees work together to develop and deliver life-saving therapies for patients with rare and serious medical conditions around the world.We are enthusiastic to expand our team and are currently looking for aRegional Security...

  • Associate Director, Global EHS Manufacturing

    vor 7 Stunden

    Bern, Schweiz CSL Behring Vollzeit

    The role of the Associate Director, Global EHS Manufacturing is to** **develop and implement programs and plans to manage EHS risks associated with manufacturing operations. Ensuring compliance with laws, regulations and company policies. Specialized focus on development, deployment and support of core technical EHS processes and standards. You will...

  • Senior Associate Scientist QC Release Specialist

    Vor 2 Tagen

    Bern, Bern, Schweiz Randstad Inhouse Services Vollzeit

    **Job Overview**Randstad Inhouse Services is seeking a highly committed Senior Associate Scientist QC Release to join our team in Bern, Switzerland. As a key member of our Quality Control and Stability team, you will be responsible for leading a team of laboratory technicians and scientists in a highly collaborative environment.**Responsibilities**Support...