About the Role
This position is focused on the qualification and validation processes fundamental to the pharmaceutical industry's compliance and operational efficiency. The role encompasses leading various qualification projects, managing computerized system validation, overseeing calibration, and ensuring adherence to regulatory compliance. You will work as part of a team dedicated to transforming culture and delivering quality solutions with integrity and compassion.
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Main Responsibilities
1. Equipment, Facilities & Utilities Qualification
- Lead and manage the end-to-end qualification lifecycle of equipment, facilities, and utilities, following the V-Model approach—from User Requirement Specifications (URS) and technical evaluations through Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and periodic requalification.
- Ensure that critical utilities, including Purified Water, Water for Injection (WFI), compressed air, and nitrogen gases, remain in a qualified and compliant state.
- Oversee cleanroom qualification and ensure compliance with ISO 14644 requirements.
2. Computerized System Validation (CSV)
- Lead and oversee the validation of computerized systems supporting Quality Control, Manufacturing, and Utilities operations.
- Ensure computerized systems comply with applicable regulatory requirements, including 21 CFR Part 11 for relevant critical systems.
- Maintain validated systems throughout their lifecycle, ensuring data integrity and regulatory compliance.
3. Calibration Management
- Oversee calibration activities for instruments and equipment, ensuring accuracy, reliability, and compliance with approved procedures and applicable standards.
- Ensure calibration schedules are maintained and deviations are addressed in a timely manner.
4. Team Leadership & Management
- Lead, coordinate, and allocate responsibilities to Validation Subject Matter Experts (SMEs), ensuring effective execution of qualification and validation activities.
- Provide technical guidance, monitor team performance, and ensure timely completion of assigned activities.
- Support capability development and continuous improvement within the team.
5. Quality Management & Regulatory Compliance
- Provide technical expertise and support in managing Change Controls, Deviation Investigations, Corrective and Preventive Actions (CAPA), and audit activities through the Electronic Quality Management System (EQMS).
- Ensure validation and qualification activities are conducted in accordance with GMP requirements, internal quality standards, and applicable regulatory guidelines.
- Support internal, external, and regulatory inspections and audits.
6. Cross-Functional Coordination & Documentation Management
- Collaborate with cross-functional teams to ensure alignment on validation activities, product lifecycle requirements, and applicable country-specific regulatory and registration requirements.
- Communicate validation progress, compliance updates, and potential risks to relevant stakeholders, ensuring timely follow-up and resolution.
- Ensure proper management, control, archiving, retrieval, and distribution of validation and qualification documentation.
7. Continuous Improvement, Risk Management & Data Integrity
- Lead and participate in quality improvement initiatives and risk management projects related to qualification and validation.
- Identify compliance gaps, assess associated risks, and implement effective and sustainable corrective solutions.
- Ensure the consistent application of data integrity principles, including ALCOA+, across relevant quality systems and processes.
8. Environmental, Health & Safety (EHS)
- Comply with the company's Environmental Management System (ISO 14001:2015), EHS policies, and applicable workplace safety requirements.
- Identify, minimize, and prevent environmental impacts and operational risks associated with daily activities.
- Promote safe working practices, including proper waste disposal and safe handling and use of equipment.
- Report hazards, incidents, non-conformities, and environmental concerns, and actively contribute to EHS audits and continual improvement initiatives.
Qualifications
- Bachelor's degree in Engineering, Science, or Pharmacy.
- Minimum of 10 years of relevant professional experience in equipment qualification, utilities qualification, calibration, and validation within the pharmaceutical or regulated manufacturing industry.
- Comprehensive knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO 9001, and ISO 14001 requirements.
- Strong understanding of applicable regulatory guidelines and standards, including FDA, WHO, and EU requirements.
- Demonstrated experience in computerized system validation (CSV), qualification lifecycle management, and calibration systems.
- Practical experience in quality management systems, audits, deviation investigations, CAPA, and risk management.
- Proven leadership experience, with the ability to manage technical teams and coordinate cross-functional activities.
- Strong analytical, problem-solving, communication, and decision-making skills.
- Proficiency in Microsoft Office applications and electronic Quality Management Systems (EQMS).
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