We are looking for an experienced QA – Calibration & Validation Manager to lead and oversee calibration, qualification, and validation activities while ensuring compliance with EU-GMP, cGMP, and applicable ISO and regulatory requirements.
The role is responsible for developing and implementing the validation strategy, managing the validation lifecycle of equipment and systems, ensuring the effectiveness of calibration and qualification programs, maintaining a validated state, and leading a specialized validation team.
The position will work closely with Quality Assurance, Engineering, Production, QC, and other cross-functional teams to ensure that facilities, equipment, processes, computerized systems, and cleanrooms remain compliant with regulatory and quality requirements.
RESPONSIBILITIES
- 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.
REQUIREMENTS
- * 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.
- 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.
- 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
BENEFITS
- * Social, Medical and Life Insurance
- Pension Coverage
- Profit Share
- Quarterly Balance Scorecard
- Transportation to the nearest point
