QA Specialist - Validation & Calibration

We are looking for a Validation & Calibration Specialist to execute and support qualification, validation, requalification, and calibration activities across MEVAC facilities, equipment, utilities, and systems. The role ensures that validation and calibration activities are properly documented and performed in compliance with EU-GMP, GMP, Data Integrity, and applicable quality standards.

• Prepare, review, and execute Validation Master Plans, protocols, and reports.
• Perform and document DQ, IQ, OQ, PQ, requalification, and periodic review activities.
• Conduct thermal mapping and temperature distribution studies for warehouses, cold rooms, incubators, refrigerators, freezers, autoclaves, and transport systems.
• Support HVAC and cleanroom qualification activities.
• Execute qualification activities for Purified Water, WFI, Compressed Air, Nitrogen, and Steam systems.
• Support cleaning validation and process validation activities.
• Review calibration and preventive maintenance records affecting validated equipment and systems.
• Participate in deviations, investigations, CAPA, change controls, and risk assessments related to validation and qualification.
• Maintain validation schedules and ensure timely completion of periodic reviews and requalification activities.
• Coordinate validation and calibration activities with Production, Engineering, QC, QA, and external service providers.
• Ensure validation and calibration documentation complies with GMP and Data Integrity requirements.
• Support regulatory inspections and customer audits.
• Review qualification and validation results and recommend approval or rejection based on established acceptance criteria.
• Escalate or stop validation activities where GMP compliance or Data Integrity concerns are identified.

Education

• Bachelor’s degree in Microbiology, Biochemistry, Chemistry, Veterinary Medicine, or another relevant scientific discipline.
• Basic knowledge of QHSE systems.

Experience

• Minimum 1 year of experience in Validation, Qualification, Calibration, or a closely related field.
• Experience in pharmaceutical, biotechnology, vaccine, or other GMP-regulated manufacturing environments is preferred.
• Practical exposure to equipment qualification, utilities qualification, thermal mapping, or calibration activities is preferred.

Technical Knowledge

• EU-GMP Annex 1 – Manufacture of Sterile Medicinal Products.
• EU-GMP Annex 15 – Qualification and Validation.
• GMP and Data Integrity principles.
• Equipment Qualification and Validation.
• Calibration principles and calibration documentation.
• Thermal Mapping and Temperature Distribution Studies.
• HVAC and cleanroom qualification.
• Pharmaceutical utilities qualification.
• Cleaning and Process Validation.
• Risk Management / ICH Q9.
• URS and risk-based Impact Assessment.
• WHO TRS 961 and applicable WHO guidance.
• PIC/S GMP requirements.
• FDA qualification and validation guidance.

Skills & Competencies

• Technical report writing and documentation.
• Strong analytical and problem-solving skills.
• Investigation and troubleshooting.
• Attention to detail and data accuracy.
• Project coordination and planning.
• Ability to manage multiple validation/calibration activities.
• Effective communication and teamwork.
• Cross-functional coordination.
• Proficiency in Microsoft Office.
• Good command of English.

• Social, Medical and Life Insurance
• Pension Coverage
• Profit Share
• Quarterly Balanced Scorecard
• Transportation from certain points