This position plays a critical role in overseeing and executing Quality Control activities that safeguard the safety, integrity, and performance of pharmaceutical products. The role ensures full alignment with regulatory requirements, internal quality standards, and industry best practices.
Key Responsibilities:
- Manage daily Quality Control operations, ensuring strict adherence to established procedures and compliance frameworks.
- Continuously assess QC workflows to identify optimization opportunities that enhance efficiency, quality, and cost-effectiveness.
- Prepare timely and accurate QC reports in alignment with departmental and organizational requirements.
- Oversee and authorize the release of finished products and materials, ensuring conformance with specifications and production timelines.
- Maintain compliance with GMP, GLP, GDP, EHS regulations, and internal SOPs.
- Supervise Goods Receipt System (GRS) entries for raw and packaging materials, ensuring precision in documentation and traceability.
- Review and approve documentation including disposal records, analytical data, trend analyses, and stability summaries prepared by the team.
- Manage inventory of essential laboratory consumables and ensure availability of critical supplies (e.g., glassware, reagents).
- Ensure all analytical instruments are calibrated on schedule to uphold data integrity and regulatory compliance.
- Safeguard accurate maintenance of laboratory documentation such as logbooks, testing records, and raw material files, and ensure proper dissemination to relevant stakeholders.
- Monitor OOS and OOT results, ensuring thorough investigations, proper recording, and escalation to the QC Manager as required.
- Analyze QC performance metrics and introduce process enhancements that drive continual improvement.
- Organize and supervise the QC team’s workload to ensure efficient, compliant execution of laboratory activities.
- Implement and uphold departmental policies and procedures to maintain operational control and consistency.
- Provide clear direction to subordinates and oversee their adherence to applicable quality and safety practices.
Qualifications:
- Bachelor’s degree in Chemistry, Biology, Biotechnology, Pharmacy, or a related scientific discipline.
- 6+ years of relevant Quality Control experience, including a minimum of 3 years in people management.
- Experience working in a multinational environment and/or participating in European, US FDA, or multinational MNC audits is strongly preferred.
- Biotechnology and biochemistry experience (electrophoresis, PCR, analytical techniques) is considered a valuable asset.
- Strong communication, leadership, and problem-solving capabilities.
