QA Industrialization Specialist
For our client, an international biopharmaceutical company, active in the fields of reproductive health, urology, gastroenterology, endocrinology and orthopaedics, we are looking for a QA Industrialization Specialist.
QA Industrialization Specialist
For our client, an international biopharmaceutical company, active in the fields of reproductive health, urology, gastroenterology, endocrinology and orthopaedics, we are looking for a QA Industrialization Specialist.Key Responsibilities:
Define, Implement, and Maintain Validation Systems:
Based in St-Prex (Vaud)
Duration 6 months
Define, Implement, and Maintain Validation Systems:
- Develop, implement, and manage the validation/qualification/calibration system in accordance with cGMPs, 21 CFR Part 11, and GAMP5.
- Conduct analytical method validation, process and cleaning validation, as well as equipment and PLCs qualification.
- Assist in various industrial projects, including but not limited to product transfers, new equipment implementation, modifications to existing manufacturing processes or equipment, and utilities enhancements.
- Contribute to the smooth execution of analytical method modifications.
- Ensure the validation/qualification status of all GxP systems.
- Perform periodic evaluations of the qualified state of production equipment and cleaning procedures.
- Oversee and ensure the manufacturing of clinical batches aligns with cGMPs.
- Develop and update SOPs and VMP related to validation/qualification.
- Apply and implement corporate and ICH guidelines.
- Organize and conduct training sessions on the qualification/validation system, Analytical Instrument Qualification, and clinical batch manufacturing as per Annex 13 of cGMP.
- Provide expertise on validation/qualification/calibration systems.
- Review and approve all validation/qualification documentation.
- Participate in assessments of deviations, CAPA, Change, continuous improvement, and troubleshooting.
- Ensure GMP compliance for production and maintenance activities, covering buildings, networks, and equipment.
- Support daily QA follow-up for maintenance, QC, and utilities activities.
- Actively prepare for health authority inspections and customer audits.
- Ensure follow-up and communication with third-party manufacturers (TPM) and customers regarding GMP activities related to Finished Sterile Medical Products (FSMP).
- Master's degree in a relevant field (e.g., Pharmaceutical Sciences, Chemistry).
- At least 5 years of experience in validation, qualification, and calibration within the pharmaceutical industry.
- Knowledge of cGMP regulations, 21 CFR Part 11, and GAMP5 guidelines.
- Proven experience in analytical method validation, process validation, and cleaning validation.
- Familiarity with equipment and PLCs qualification.
- Excellent written and verbal communication skills.
- Strong project management and problem-solving abilities.
- Ability to work effectively in a cross-functional team and adapt to evolving priorities.
- Quality-driven mindset with a keen attention to detail.
- Regulatory knowledge and experience with health authority inspections is a plus.
Based in St-Prex (Vaud)
Duration 6 months
Contact
Loïc Champlong
À propos de l'entreprise
