Senior Officer - Quality Assurance
Factory Operations & Production Management
Responsibilities:
- Documentation & Compliance:
- Prepare and maintain production-related documents, including Standard Operating Procedures (SOPs) and logbooks.
- Ensure all documentation is accurate, up-to-date, and aligned with regulatory and internal quality standards.
- Commercial Batch Manufacturing:
- Oversee the production of commercial batches under the guidance of the Department Lead, ensuring strict adherence to Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
- Conduct in-process quality checks (IPQC) as per BMR/BPR guidelines.
- Cross-check workflow, material labeling, and quantity accuracy as per BMR/BPR requirements.
- Ensure proper sanitation and maintenance of the production area.
- Enforce compliance with SOPs and GMP regulations.
- Assist in workforce management based on workload distribution under the guidance of the Department Lead.
- Ensure smooth operation and maintenance of all production machinery and utilities.
- Workplace Environment & Safety:
- Implement and maintain 5S methodology during batch trials.
- Ensure workplace discipline and adherence to safety protocols.
- Possess basic knowledge of first aid and emergency procedures.
- Report any equipment malfunctions or safety concerns to immediate supervisors.
- Ensure compliance with workplace safety, hygiene, and GMP standards.
- Communicate equipment, stationery, and repair requirements to the respective authorities.
- Record Maintenance & Reporting:
- Maintain daily activity records and oversee junior staff accountability.
- Ensure timely completion and accuracy of BMR/BPR documentation.
- Supervise batch labeling and production logbook maintenance.
- Maintain calibration records for all production instruments.
Job Specification:
Professional Competencies:
- Bachelor’s degree in Pharmacy, Chemistry, or a related field.
- 2 – 3 years of experience in Quality Assurance within a pharmaceutical or manufacturing environment.
- Strong understanding of GMP, SOPs, and regulatory compliance.
- Excellent attention to detail and organizational skills.
- Ability to work collaboratively with cross-functional teams.
- Proficiency in documentation and record-keeping.
Behavioral Competencies:
- Integrity (Instils trust)
- Authentic – communication, behavior & actions.
- Manage the professional & procedural ambiguity.
- Courageous and soundly confident.
- Flexibility & adaptability.
- Hard working & practices prioritization.