CSV Specialist

• Provide compliance leadership, direction and oversight to project teams in the area of Computer System Validation.
• Responsible for the quality oversight of GxP regulated computerized systems (e.g. manufacturing plant systems, laboratory systems and enterprise applications).
• Manage the release of regulated systems for GxP production use.
• Participate in the review and approval of technical changes, Quality Incidents, CAPAs and procedures.
• Contribute to establishing and deploying processes, compliance-driven standards, and procedures (as required), determining boundaries for harmonization and alignment versus differentiation, and ensuring they remain current with FDA and global regulatory requirements for GxP computerized systems.
• Participate in evaluating the current Crucell quality systems for GxP computerized systems, and implement improvements to comply with the current FDA/EU standards.
• Provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 210, 211, 58, 820, 11 and EU Annex 11 EU).
• In addition, this individual will lead and participate in project teams and may participate in regulatory inspections and client audits Minimum Qualifications:
• Bachelors or Masters degree in science, computer science, or relevant area.
• Thorough knowledge of cGMP, in manufacturing and R&D within GxP regulated industries.
• A minimum of 7 years relevant working experience in a pharmaceutical or biotechnology company of which preferably 3 years in validation or QC, and in QA/CSV.
• In-depth knowledge of computerized quality systems.
• Experience with GMP inspections Competences:
• Communicative skills.
• Negotiation skills.
• Convincing.
• Team player.
• Accuracy.
• Problem solver.

• CSV, 21 CFR part 11, Data integrity, Archiving.

Last updated on Nov 7, 2023