QA Manager @Nipa Pharmaceuticals Ltd.

Job Responsibilities

• Organize and carryout analytical activities of raw materials, packing materials and finished products and to ensure quality of product by implementing guidelines of WHO, ICH, FDA, TGA, etc.
• Perform in process Checking, BMR, BPR and SOP’s preparation and checking during manufacturing of products.
• Participate in all qualification and validation activities.
• Ensure proper documentation of all quality assurance related documents.
• Ensure other activities like environment control, water sanitation, waste disposal, HVAC system validation, and ETP, housekeeping, health & personnel hygiene.
• Ensure required Training of QA/Production/Engineering/Ware house personnel.
• Maintain all Compliance related activities and documentation.
• Would be a plus if familiar with dossier preparation for International market and other export related work.
• Responsible for all In Process Quality Assurance activities (IPQA) on the shop floor including quality oversight and Batch record review.
• Responsible to perform SAP (SHAPE) activities in the QM Module and will be the part of Deviation Management, investigation of market complains and other compliance activities.
• Sampling & Analysis of Raw Materials, Packaging Materials, Finished Products and Water.
• Handling of all sophisticated QC instruments like HPLC, GC, UV-VIS, FTIR, TOC, Dissolution tester, Karl fisher auto titrator & Disintegration tester etc.
• Preparation and review of SOPs, specifications & methods for raw material, packaging material & finished product etc.
• Validation of analytical methods, Cleaning & Qualification of equipment’s.
• Preparation & standardization of volumetric solution, secondary working standards from reference standard etc.
• Calibration of all sophisticated QC equipment’s.
• Handling of OOS with proper investigation.
• Maintain GLP & housekeeping and make corrective measures for any deviation.