jjjp00026299 - quality systems (qs) reviewer

Quality Systems & QA Responsibilities

• Investigation Review: Perform end-to-end reviews of nonconformity risk assessments and CAPA investigations in compliance with global and local procedures.
• Cross-Functional Collaboration: Partner with investigation teams and QA members to guarantee investigations and risk assessments are thoroughly and properly documented.
• Coaching & Mentorship: Coach personnel involved in the Nonconformity and CAPA handling process on best investigational practices.
• Timely Delivery: Coordinate with team members and process stakeholders to ensure reviews are completed in a timely manner.
• Compliance & Standards: Execute all tasks in alignment with cGMP requirements, quality systems, and safety policies.

Safety, Health & Environment (SHE) Responsibilities

• Monitor compliance with legal requirements in partnership with the SHE department.
• Adhere strictly to prevention rules and safety procedures.
• Actively participate in safety promotion and awareness campaigns.
• Promptly report any accidents, incidents, damages, or unsafe/environmentally harmful situations to senior leadership.
• Propose solutions to prevent unsafe conditions (e.g., via suggestion forms, accident investigations, and safety committee participation).

• Education: Master’s degree in a scientific or technical field (Analytics, Chemistry, Biotechnology, Pharmaceutical Sciences, Engineering) or equivalent experience.
• Experience: Minimum of 5 years of experience in Quality Systems or Quality Assurance related to manufacturing.
• Domain Knowledge: Strong knowledge and understanding of cGMP regulations related to sterile manufacturing, as well as ICH guidelines, policies, and standards.
• Process Expertise: Solid understanding of Quality Systems processes, specifically nonconformity and CAPA handling.
• Coaching & Communication: Proven experience in coaching personnel, paired with strong analytical thinking and clear verbal/written communication skills.
• Personal Traits: Highly organized, capable of working under daily supervision in a team environment with a positive attitude.
• Languages: Fluent in English (written and spoken).
• Systems: Familiarity with COMET, Truvault, SUMMIT, and MS Office.

• Salary, bonus & rewards:

  Our offer

  • competitive gross salary with 13th month and double holiday pay
  • monthly net allowance
  • meal vouchers & eco vouchers
  • choice between company car with fuel/charging card (SalSa plan) or mileage reimbursement for using your own car
  • hospitalization insurance from day 1 + optional outpatient insurance (incl. dental care)
  • group insurance (pension savings)
  • cafeteria plan (Flex Income Plan)
  • 4 weeks of statutory holiday + 12 ADV days + seniority leave
  • possibility to work from home (depending on project)
  • Benefits at Work discount platform
  • referral bonus when you recommend a new colleague
  • personal follow-up via account manager, HR/L&D support, access to training, learning tools and certifications
  • networking events and internal activities to stay connected with colleagues and the organisation

  Prefer to work as a freelance consultant?

  • we pay your invoices on time and correctly (30 days)
  • our team of recruiters and account managers is closely involved in your career and follows you up
  • towards the end of your project, we proactively look for your next assignment