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:

  • 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 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.