Nipa Pharmaceuticals Ltd.
Requirements
Education
- Master of Pharmacy (M.Pharm)
Experience
- 10 to 15 years
- The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
Additional Requirements
- Age 40 to 55 years
Responsibilities & Context
- 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 SOPs 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 autotitrator & 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 equipments.
- Preparation & standardization of volumetric solution, secondary working standards from reference standard etc.
- Calibration of all sophisticated QC equipments.
- Handling of OOS with proper investigation.
- Maintain GLP & housekeeping and make corrective measures for any deviation.
To apply for this job email your details to apply@chakricircular.com