QA specialist CSV - Stein

QA Specialist – CSV & Automation

We are looking for a QA Specialist, CSV & Automation to support qualification and validation activities for equipment and computerized systems within aseptic drug product manufacturing. This role sits within a broader CAPEX project portfolio and covers major initiatives from concept through execution, including large new facility builds.

Responsibilities:

• Develop and maintain qualification/validation plans aligned with internal Quality policies.

• Review and approve SOPs, CQV/CSV protocols, reports, and project documentation (e.g., URS, FAT/SAT).

• Provide QA leadership and oversight on qualification and validation topics throughout ongoing projects.

• Ensure vendors meet qualification and compliance requirements.

• Act as the primary QA contact for equipment, infrastructure, and computerized-system lifecycle and compliance matters.

• Manage documentation within global quality systems such as electronic validation and quality management platforms.

• Handle deviations, changes, and CAPAs in a timely and proactive manner.

Requirements:

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related discipline.

• Strong experience in a GMP-regulated pharmaceutical environment, ideally within a Quality Unit.

• Proven background in QA for CSV/Automation of GMP systems supporting aseptic fill-finish operations (filling equipment, lyophilizers, clean utilities, cleanrooms).

• Fluency in English; additional languages are an advantage.

For more information or to apply:
Email: s.canelas@panda-int.com
Phone: +31 6 3150 1862