Quality Assurance Specialist
vor 1 Woche
Direct message the job poster from Panda International
Senior Recruitment Consultant - I help top talent find their next opportunity in leading Life Sciences companiesJob Overview:
We are seeking a highly skilled and experienced professional to supervise compliance and customer Quality Agreement (QAA) activities for drug production. This role requires close collaboration with Drug Product Services (DPS) in Basel/Stein sites (e.g., Slough/Visp) to establish and negotiate Quality Agreements.
Key Responsibilities:
- Establish, negotiate, and maintain Quality Agreements (QAA) in collaboration with DPS and DS sites.
- Act as the primary point of contact for Drug Product QA-related inquiries, topics, and customer complaints.
- Support and manage interactions in cases of changes, deviations, technical complaints, out-of-specification results, and other quality-related matters.
- Represent Quality Assurance in cross-functional teams and maintain interfaces with Manufacturing, QC, Support Functions, Project and Site Engineering for effective task execution.
- Serve as the QA representative in project teams and customer meetings during technical transfers.
- Act as the QA contact for specific projects, ensuring regular follow-ups on DR and CR with customers.
- Support and approve project/product-specific risk assessments, regulatory gap analyses, and risk evaluations.
- Review and release product-specific documentation, including process descriptions, workflows, recipes, manufacturing protocols, transfer documents, test plans, and parameter lists.
- Work closely with QC-Project Leaders (QC-PL) and MSAT for New Product Introductions (NPI).
- Assess, review, and approve quality records such as deviations, change control, CAPAs, investigations, effectiveness checks, and extensions in compliance with local SOPs.
- Author, review, and approve GMP-relevant documents and SOPs.
- Support continuous improvement programs to enhance the Quality Management System for Drug Product.
Qualifications & Experience:
- Bachelor's or Master’s degree in Life Sciences, Pharmacy, or a related field.
- 5-10 years of relevant experience in Quality Assurance within drug production or pharmaceutical manufacturing.
- Strong knowledge of GMP regulations and compliance requirements.
- Experience in negotiating and managing Quality Agreements with external partners.
- Ability to assess and resolve quality-related issues, including deviations, complaints, and investigations.
- Proven ability to work cross-functionally with Manufacturing, QC, Engineering, and Regulatory teams.
- Excellent communication and stakeholder management skills.
- Proficiency in English is mandatory; German is a strong asset.
NOTE: this is a project until the end of the year.
Interested? Send your CV to Daria at d.finikova@panda-int.com or call +41445514407 for more info.
Seniority levelMid-Senior level
Employment typeFull-time
Job functionEngineering and Quality Assurance
IndustriesPharmaceutical Manufacturing, Manufacturing, and Biotechnology Research
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