CSV Lead Specialist
- Leiden
- 5000.00 - 7000.00
- 32-40 hours
- Bachelor degree
Client
Our client is a leading consulting and engineering firm in pharma, food and chemistry.
Client
Our client is a leading consulting and engineering firm in pharma, food and chemistry. They participate in interesting projects in the pharmaceutical industry. They do this by providing support to clients on challenging and varied projects. Usually with the opportunity for personal development in addition to your contribution.
Requirements
- 5 to 10+ years experience in CSV roles within GMP-compliant environments.
- Demonstrated expertise in building and executing CSV strategies and producing comprehensive validation documentation from inception.
- Hands-on experience validating Quality Management Systems, Data acquisition systems such as SCADA, BMS, EMS, SAP (or other ERP systems) and relevant software for analytical purposes (e.g. HPLC software from Waters, Labguru).
- Deep knowledge and practical application of GAMP 5, Annex 11, and 21 CFR Part 11 regulatory requirements.
- Proven track record in facility startup projects and regulatory inspection readiness related to CSV.
- Strong ability to develop and maintain system inventories and conduct impact assessments for validation scope determination.
- Advanced knowledge of risk-based validation principles and scalable validation based on system criticality and category.
What do you get?
- Pension entitlement as from day one
- Collective WGA / WIA insurance
- NBBU / ABU collective labor agreement
- 25 holidays days
- 8,33% holiday allowance
- 100% payment in case of illness after one waiting day
- Travel allowance
Duties
- Develop, author, and maintain the CSV Master Plan (CSVP) aligned with the overall Validation Master Plan (VMP), defining system criticality, validation approaches per GAMP 5, and lifecycle management strategies for GMP systems.
- Lead the creation and upkeep of a comprehensive GxP system inventory, including classification by GMP relevance, system ownership, and audit status.
- Conduct system impact assessments to determine the scope and depth of validation efforts required for individual systems.
- Apply deep expertise in GAMP 5 guidance for categorizing systems, performing risk assessments, and tailoring validation documents and activities based on system classification.
- Ensure the validation of; Quality Management Systems (QMS), Data acquisition systems such as SCADA, BMS, EMS, SAP (or other ERP systems) and relevant software for analytical purposes (e.g. HPLC software from Waters, Labguru) that are GMP-relevant
- Provide expert support for facility startup activities and regulatory inspections related to CSV.
- Collaborate cross-functionally with Quality Assurance, IT, and business units to ensure compliant and efficient validation strategies.
- Drive continuous improvement in CSV processes and documentation aligned with regulatory changes and industry best practices.
