- Lead and manage the overall Quality Control function and QC laboratory.
- Ensure compliance with cGMP, GLP, ICH, WHO and regulatory requirements.
- Oversee testing and release of raw materials, packing materials, in-process and finished products.
- Review and approve specifications, analytical reports, SOPs, protocols and COAs.
- Handle OOS, OOT, deviations, investigations and CAPA effectively.
- Manage stability studies, method validation/transfer and analytical activities.
- Ensure readiness and support for regulatory and customer audits/inspections.
- Ensure compliance with HPLC, GC, UV, dissolution and other analytical instruments, including calibration and maintenance.
- Lead, train and develop the QC team and ensure optimum utilization of resources.
- Drive continuous improvement, laboratory efficiency and quality compliance.
Required Skills
- Solid knowledge of Pharma QC GMP
- Regulatory audit and inspection handling
- OOS/OOT, CAPA deviation management
- Analytical method validation/transfer
- Stability laboratory management
- Strong leadership and team management skills