Quality Validation / Qualification Specialist
Paiania, Attica, GreeceRemoteFull-time
AI Summary
Lavipharm is seeking a Quality Validation / Qualification Specialist, based in Athens, who will be responsible for compliance to GMP and regulatory requirements of facilities, utilities, equipment and computerized systems.
About this role
Lavipharm is seeking a Quality Validation / Qualification Specialist, based in Athens, who will be responsible for compliance to GMP and regulatory requirements of facilities, utilities, equipment and computerized systems.
Responsibilities
- Plan, overview execution, review results and approve qualification and validation activities (DQ, IQ, OQ, PQ)
- Ensure appropriate prioritization of validation activities regarding manufacturing equipment, utilities, facilities and computerized systems
- Issue, review and approve validation protocols, reports and supporting documentation
- Maintain validation status throughout the lifecycle of systems and equipment
- Provide QA oversight for change control, deviations and CAPAs related to validation
- Ensure application of risk-based approaches to validation/qualification activities
Requirements
- Bachelor’s degree preferably in Engineering or Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology or other relevant field
- Postgraduate qualification (master’s degree or equivalent) in a relevant field is preferred
- At least 5 years experience in Quality manufacturing/systems preferably in Human Pharma Industry
- Excellent knowledge of the English language
- Computer Literacy (MS Office etc)