QA Industrialization Specialist

Key Responsibilities: 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. Support Industrial Projects: 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. Validation and Qualification Oversight: Ensure the validation/qualification status of all GxP systems. Perform periodic evaluations of the qualified state of production equipment and cleaning procedures. Clinical Batches Oversight: Oversee and ensure the manufacturing of clinical batches aligns with cGMPs. Documentation and Training: 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. Expertise and Compliance: 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. GMP Compliance: Ensure GMP compliance for production and maintenance activities, covering buildings, networks, and equipment. Support daily QA follow-up for maintenance, QC, and utilities activities. Inspection Readiness: Actively prepare for health authority inspections and customer audits. FSMP Follow-Up: 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 3 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. 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.

Location: saint-prex, CH

Posted Date: 11/27/2024