Quality Assurance Specialist Drug Product
vor 3 Wochen
Are you interested in joining a leading global organization as a Quality Assurance Specialist Drug Product (m/w/d)? Our client is seeking to enhance their team with a dedicated professional in this role. This position offers a hybrid work model, allowing for remote work one day a week or as needed. The contract is currently limited in duration, with the possibility of extension.
Your Responsibilities:- Manage and resolve discrepancies (events and deviations) as the QA representative.
- Oversee and address Out of Specification (OOS) results as the QA lead.
- Conduct process observations within the production units of the BioPharma Drug Product, focusing on sterile filling (isolators and RABS lines), visual inspection, and packaging.
- Review and approve change requests and documentation.
- Represent QA during audits and inspections.
- Ensure regulatory compliance and adherence to international cGMP and internal guidelines.
- Support the enhancement of the internal quality management system and the establishment of uniform standards.
- Act as a point of contact for all quality-related inquiries concerning production and QC processes.
- Track quality-related tasks and decisions, exercising independent decision-making for routine matters, and proactively escalate issues when necessary.
- Be prepared for staggered working hours and on-call duties, including potential weekend work based on production needs.
- Master's degree with several years of professional experience or equivalent qualifications in pharmacy, biopharmacy, biology, or chemistry.
- In-depth knowledge of biopharmaceutical manufacturing (sterile filling, visual inspection, and packaging), particularly regarding compliance and quality-related issues in process and quality control, with extensive experience in GMP compliance and quality matters.
- Strong understanding of regulatory requirements.
- Experience with audits and inspections.
- Excellent negotiation and communication skills.
- Enjoyment of teamwork.
- Flexibility in work planning: staggered hours and on-call duties, including potential weekend work based on production requirements.
- Proficient in both German and English, with strong written and verbal communication skills.
- Monthly Salary: 5,200 EUR gross
- Performance-based variable compensation/bonus
- Weekly working hours: 37.5 hours
- Holiday and Christmas bonuses
- Up to 30 days of tariff vacation
- A responsible role in an innovative pharmaceutical company
- Comprehensive onboarding with a motivated team
- Opportunities for professional development
Are you excited about a new and challenging career opportunity in a successful, rapidly growing international company?
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