Product quality expert
vor 2 Wochen
- As Product Quality Expert (PQE), you will report directly to the Head of Quality Compliance & Systems and be responsible for compliance/regulatory activities related to biologic products.
- Regulatory Compliance activities
- Interaction with Authorities
- External inspections and internal audits
- Quality projects
How you will contribute:
- Regulatory compliance:
- Be responsible for biological product manufacturing on-site and act as an expert for all topics related to regulatory compliance for this product.
- Prepare Product Quality Reviews (PQR) for products manufactured at the facility annually and according to health authority requirements.
- Review global release specifications, ensuring the implementation of correct updated versions for products manufactured at the facility.
- Participate in Good Manufacturing Practice (GMP) tours of the facility to ensure inspection-ready status.
- Interaction with authorities:
- Act as a 'Subject Matter Expert' (SME) in the creation and modification of regulatory license sections for products manufactured on-site.
- Manage/prepare necessary supportive documentation for regulatory submissions and major change projects at the facility.
- Prepare/Review documentation for change controls, audit observations, and regulatory agency questions.
- Support/Write responses to regulatory agency questions and facilitate collaboration among Subject Matter Experts to achieve required documentation.
- External inspections and internal audits (corporate):
- Support the preparation of inspections.
- Support the preparation of pre-required documents.
- Participate in audits and inspections as required.
- Help define the strategy of responses to health authority questions as part of the quality matrix team.
- Update all records relative to inspections when necessary.
- Propose improvement initiatives to simplify and streamline tasks described above.
- Routine and Quality Projects:
- Assist in preparation and review of all quality documentation as required.
- Participate in Quality Council meetings as necessary.
- Support coordination of site Key Performance Indicators (KPIs).
- Participate in project teams when necessary.
- Participate in product launch activities.
- Identify opportunities to improve quality processes.
- Collaborate with global Quality Product Leads and Regulatory Affairs partners.
- University degree in technical/scientific discipline such as biochemistry, chemistry, engineering, or equivalent
- 3-5 years of experience with manufacturing in biotechnology and/or pharmaceutical industry
- Experience in writing and/or reviewing e CTD licenses (quality - module 3) is an asset
- Experience with regulatory affairs framework is an asset
- Knowledge of FDA, EMA, ICH, Pharmacopoeia regulations, Quality system standards, and data integrity principles
- Experience as a change owner or project leader
- Knowledgeable in GMP inspections and management of regulatory/quality standards
- Fluent in English and French
- Knowledge/Experience with quality tools such as Trackwise, Veeva, e CTD viewer
- Good analytical skills and ability to simplify the complex
- Problem-solving oriented
What is offered:
- Competitive salaries
- Full accident coverage
- Participation in health insurance premiums
- Advantageous pension plans
- Subsidized meals
- Financial participation in employee sports activities
- Transport support for local public transport passes, free parking, car sharing program
- Attractive working environment and conditions
- Commitment to well-being, safety, development, and career advancement
About the Company:With over 700 employees, the company is one of the ten largest employers in Canton of Neuchâtel and one of the leading biopharmaceutical production sites in Switzerland. Operating 24/7, the site employs professionals trained in biotechnologies and their application in industrial production, offering an international, diverse, and innovative working environment within a company firmly rooted in its local ecosystem. Certified as a training company, they train young apprentices in various fields, emphasizing its commitment to diversity and equal employment opportunities.
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