Senior Scientific Officer
2 weeks ago
Position Title : Senior Scientific Officer/Scientific Officer-Quality Assurance -Validation
Educational Qualification : M.Sc. - Microbiology/Biotechnology, B.Tech- Biotechnology,
Experience : 3 to 7 years
Job Summary:
Senior Scientific Officer- Validation (QA) shall be responsible for ensuring the quality and efficacy of vaccine Drug Substance Plant, Lalru (Punjab). This position will be responsible for overseeing the Qualification/ validation of various Equipment/ System i.e. HVAC Filling line, Autoclave, Tunnel, Fermenters, DHS, refrigerators, Process tanks etc.
1. Preparation and Review of SOPs/Protocols
- Develop and review Standard Operating Procedures (SOPs) and validation protocols related to equipment, systems, and facilities.
- Conduct training sessions for relevant personnel on validation processes and compliance standards.
2. Validation of Systems and Equipment
- Execute and review validation activities for:
- HVAC systems : Air handling units, cleanroom validations.
- Water systems : Purified water, WFI (Water for Injection), and distribution systems.
- Equipment: Autoclaves, DHS (Dry Heat Sterilizer), refrigerators, cold rooms, deep-freezers, fermenters, process tanks, garment washing machines , and more.
3. Process and Cleaning Validation
- Plan, execute, monitor, and review:
- Process Validation : Ensuring consistent and reproducible manufacturing outcomes.
- Cleaning Validation : Establishing and verifying cleaning procedures to prevent cross-contamination.
4. Equipment Qualification (URS, DQ, IQ, OQ, PQ)
- Manage User Requirement Specifications (URS) , Design Qualification (DQ) , Installation Qualification (IQ) , Operational Qualification (OQ) , and Performance Qualification (PQ) .
- Review qualification protocols and results to ensure compliance with GMP requirements.
5. Validation Planner and Coordination
- Prepare and review a Validation Master Plan (VMP) and validation planner.
- Coordinate with cross-functional teams (CFTs) for smooth execution of validation activities.
6. Revalidation and Calibration
- Periodically review validation and revalidation data for equipment and systems.
- Monitor calibration plans and review calibration certificates to ensure adherence to standards.
7. Risk Assessment and Methodologies
- Apply risk assessment concepts and methodologies (e.g., FMEA, HACCP) to validation processes and ensure a risk-based approach to compliance.
8. Documentation and Compliance
- Ensure proper documentation and review for all validation and qualification activities as per GLP (Good Laboratory Practices) and GDP (Good Documentation Practices) standards.
Competencies Required
- Aseptic Behavior: Demonstrate and enforce proper aseptic techniques and practices in validation and operations.
- Cross-Functional Coordination: Collaborate effectively with cross-functional teams (e.g., QA, Production, Maintenance, and R&D) to ensure timely execution and closure of validation activities.
- Data Integrity: Strong understanding and adherence to Data Integrity Principles, ensuring accuracy, completeness, and traceability of validation data.
- Timely Execution: Proactively follow up and ensure timely closure of validation activities, deviation investigations, and change controls.
- Compliance Adherence
- Ensure strict adherence to:
- GLP (Good Laboratory Practices)
- GDP (Good Documentation Practices)
- Plant compliance standards and regulatory requirements.
- Detail-oriented with strong analytical and problem-solving skills.
- Strong communication and coordination abilities to manage cross-departmental collaborations.
- Ability to manage multiple validation projects and prioritize tasks effectively.
- In-depth knowledge of pharmaceutical regulatory guidelines.
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