- Handling all QC functions
- Planning Quality control as per testing requirement
- Approval of PM, RM, FP.
- Stability report in LIMS
- Responsible for all software validation in QC as per CFR, GMP, and pharmacopeia.
- Review SOPs related to QC
- Responsible for maintaining GLP
- Responsible for all QMS documentation
- Responsible for training of QC staff (e.g. Lab techniques, GLP, General Analytical Methods, QC procedures and principles
- Responsible for audit facing (Regulatory, self-inspection, etc..) and meet auditors requirements
- Preparing investigation reports of OOT / OSS / OOC, change control and deviation related to QC
- Prepare yearly QC Budget
- Provide support to identify root cause analysis and CAPA
- To ensure the implementation and effectiveness of CAPA
- Responsible for validation and qualification related to QC requirements.
- Should have knowledge of QC instruments & calibration.
- To monitor & approve water analysis trend charts
- To monitor & approve micro lab activities.
Location: Daman & Diu
Qualification: B.Sc/B.Pharma, MS/M.Sc/M.Pharma
Experience: 8-13 Years
Mr. Darshak Thakkar