QA Manager Qualification & Validation (CSV) (m/f/d)

Location: 23942 Dassow

Scope: Full-time

Start:  Immediately

AqVida is a pharmaceutical sterile manufacturer specializing in high-quality medicines for international markets. To strengthen our Quality Assurance (QA) team, we are looking for a dedicated professional to oversee QA-related qualification and validation activities—particularly in the area of computer system validation (CSV) for our computerized systems.

For our production site in Dassow (23942, Mecklenburg-Western Pomerania), which we are currently expanding, we are seeking, as soon as possible, a

QA Manager Qualification & Validation (CSV) (m/f/d) 
Full-time

Your Responsibilities:

• QA oversight of (re-)qualification and validation activities (e.g., equipment, processes, IT systems) at the Dassow production site.
• Lead coordination and monitoring of computer system validation (CSV) in compliance with GxP requirements and Annex 11 / 21 CFR Part 11.
• Review, approval, and further development of validation and qualification documents (URS, risk assessments, IQ/OQ/PQ, etc.).
• Contribute to the implementation of a maintenance module in the QM software.
• QA support for changes (Change Control) and projects in technical and IT environments.
• Participation in daily QA tasks such as audits (internal/customer), inspections, reviews, etc.
• Support continuous improvement of the pharmaceutical quality system and ongoing GMP compliance.

Your Profile:

• Successfully completed degree in a scientific or technical field (e.g., pharmacy, chemistry, biotechnology, medical technology, computer science).
• Several years of professional experience in pharmaceutical quality assurance or a GMP-regulated environment.
• Solid knowledge of qualification & validation, ideally with a focus on computer system validation.
• Confident handling of regulatory requirements (EU-GMP, Annex 11, GAMP 5, 21 CFR Part 11).
• Strong communication skills, precise working style, and enthusiasm for cross-functional collaboration.
• Excellent communication skills in German; good English skills, both written and spoken.

What We Offer:

• A responsible role in a growing, internationally oriented sterile manufacturing company.
• Short decision-making paths, direct interaction with specialist departments, and modern work structures.
• Attractive development opportunities in a professional QA environment.
• A motivated team and flexible working conditions.
• Subsidy for company pension scheme or capital-forming benefits.
• Subsidy for the Deutschland-Ticket.
• Corporate fitness: Wellpass membership at an employee contribution of €29 per month.

If this sounds like you and you want to actively shape the future of AqVida, we look forward to receiving your application documents (CV, current certificates, salary expectations, start date) by email as a single PDF file (max. 3 MB) to bewerbung@aqvida.com.