QA Calibration and Validation Manager

• Develop, implement, and continuously improve a comprehensive validation and qualification strategy aligned with EU-GMP and company requirements.
• Plan, prioritize, and manage calibration, qualification, and validation activities to achieve business and quality objectives.
• Lead and oversee equipment qualification, process validation, cleaning validation, computerized system validation, and related validation activities.
• Manage the complete lifecycle of validated equipment and systems, including planning, execution, review, approval, periodic review, change control, and documentation retention.
• Review and approve qualification and validation protocols, reports, and related documentation prior to equipment/system release.
• Establish and maintain an effective calibration program in accordance with EU-GMP and applicable standards.
• Ensure calibration and validation activities are performed in compliance with approved procedures, EU-GMP, cGMP, and applicable ISO standards.
• Ensure the validated state of manufacturing facilities, equipment, utilities, cleanrooms, and critical systems is maintained.
• Ensure appropriate environmental monitoring and control measures are implemented for cleanrooms in accordance with EU-GMP requirements.
• Oversee validation activities related to sterilization, temperature mapping, cold chain, container closure systems, media fills/aseptic process simulation, and environmental monitoring.
• Ensure appropriate application of risk-based approaches to qualification and validation activities.
• Review and approve User Requirement Specifications (URS), impact assessments, risk assessments, qualification documents, and validation reports.
• Ensure appropriate implementation of Computerized System Validation (CSV) / Computer Software Assurance (CSA) requirements.
• Ensure compliance with data integrity principles and applicable requirements for electronic records and electronic signatures.
• Collaborate with QA and other departments to maintain a compliant and effective validated environment.
• Develop, review, and approve quality documentation related to QMS, EMS, EnMS, OHSMS, and EU-GMP requirements.
• Monitor the effectiveness and continual improvement of the Quality Management System.
• Follow up on CAPA implementation and ensure timely closure of validation- and compliance-related actions.
• Support internal and external audits and ensure timely response to audit observations and regulatory requirements.
• Prepare and submit monthly quality and validation metrics for QA Manager and Top Management review.
• Participate in Management Review Meetings and present validation performance, progress, compliance status, and key quality metrics.
• Ensure direct reports receive appropriate training on GMP, validation, quality procedures, and technical requirements.
• Assess team competency and develop technical capabilities through structured training, workshops, and technical discussions.
• Lead, coach, and develop the Validation team to ensure effective execution of departmental objectives.
• Ensure all activities comply with applicable EU-GMP and ISO 9001, ISO 14001, ISO 45001, ISO 17025, and ISO 50001 requirements.
• Ensure readiness to respond effectively to emergencies in accordance with the company's emergency response plan.
• Promote a strong quality culture and ensure all validation activities support continuous compliance and operational excellence.

Education

• Bachelor's degree in Veterinary Medicine, Microbiology, Biochemistry, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Strong understanding of EU-GMP and pharmaceutical quality systems.
• Good knowledge of QHSE management systems.
• Strong understanding of pharmaceutical/biopharmaceutical manufacturing, quality systems, and development processes.

Professional Experience

• Minimum 10 years of relevant experience in the pharmaceutical, biopharmaceutical, vaccine, or related regulated manufacturing industry.
• Proven managerial experience in Quality Assurance, Validation, Qualification, or a closely related function.
• Strong hands-on experience in equipment qualification, calibration, cleaning validation, and process validation.
• Experience managing validation teams and cross-functional validation projects.

Technical Knowledge

Strong knowledge of:

• EU-GMP regulations and GMP principles
• EU-GMP Annex 1 – Manufacture of Sterile Medicinal Products
• EU-GMP Annex 11 – Computerised Systems
• EU-GMP Annex 15 – Qualification and Validation
• ICH Q9 – Quality Risk Management
• ICH Q10 – Pharmaceutical Quality System
• ICH Q2 – Analytical Procedure Validation
• FDA 21 CFR Part 11 – Electronic Records and Electronic Signatures
• FDA 21 CFR Parts 210/211 – cGMP for Finished Pharmaceuticals
• Cleaning Validation and PDA TR29
• Process Validation lifecycle approach – Stages 1, 2, and 3
• Media Fill / Aseptic Process Simulation (APS)
• Container Closure System (CCS) validation
• Sterilization validation, including autoclave, dry heat, and filtration
• Environmental Monitoring Program qualification
• Cold Chain and Temperature Mapping Validation
• Computerized System Validation (CSV)
• Computer Software Assurance (CSA)
• Equipment Qualification
• Calibration Management
• User Requirement Specifications (URS)
• Risk Assessment and Impact Assessment
• Data Integrity
• Supplier Qualification
• Internal and External Audits
• Pharmaceutical Quality System (PQS)
• Gowning strategy and gowning qualification

• Social, Medical and Life Insurance
• Pension Coverage
• Profit Share
• Quarterly Balance Scorecard
• Transportation to the nearest point