Investigations Lead
vor 3 Wochen
For over 130 years, diversity, equity & inclusion have been integral to our culture at Johnson & Johnson and woven into every aspect of how we conduct business.
We understand that the success of our business relies on having the best talent in a workforce that reflects the diverse markets we serve globally and an inclusive culture that values diverse perspectives and life experiences.
This is why we in Switzerland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each individual feels they belong and can reach their potential. Regardless of 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 leading the E2E investigation process from initiation to writing of impact assessment, executing the investigation of Medium/High Impact Non-conformances, aiming to identify assignable and/or root cause, and implementing corrections, Corrective and/or Preventive Actions to prevent recurrence and perform effectiveness checks.
Main Responsibilities:
- Independently lead non-conformance issuance, performance of impact assessments and respective investigations to prevent recurrences in support of Manufacturing operations.
- Gathering data from various sources across the site, performing Root Cause Analysis (RCA) to determine the most likely cause of the non-conformance investigation, identifying corrections and corrective/preventative actions to reduce or prevent recurrence.
- Routine interaction with Operations, Quality Control, Quality Assurance and other departments to communicate investigational status, align meetings, facilitate reviews, CAPA discussions and comments resolution.
- Technical writing of investigation reports for an educated but uninformed reader, accurately capturing 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 performing associated interviews (e.g. operators).
- Meeting facilitation and participation, aligning both internal and quality review teams and subject matter experts on an agreed investigational path forward.
- Management of multiple quality investigation projects and timelines concurrently, adhering to standard timelines and escalating actions appropriately for timely resolution.
- 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 during investigations during audits/health authorities' inspections.
Qualifications
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 role is based in Bern, Switzerland and will initially be limited to approximately 12 months. If you are interested in working with a global leading pharmaceutical company in a dynamic, progressive, and collaborative environment, then please submit your application today.
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