Assistant Manager – QC/QA
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/QC/Production/Engineering/Ware house personnel.
- Maintain all Compliance related activities and documentation.
- Would be a plus if familiar with dosser 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 equipment’s.
- Preparation & standardization of volumetric solution, secondary working standards from reference standard etc.
- Calibration of all sophisticated QC/QA equipment’s.
- Handling of OOS with proper investigation.
- Maintain GLP & housekeeping and make corrective measures for any deviation. Broad experience dealing with Regulatory Bodies Excellent Leadership and communication skills.
- Expert user of MS Word, MS Excel and Power point presentation.
- Analytical abilities, creativity, innovative ideas and a self-driven attitude; should possess a strong presence of mind combined with problem solving and decision making skills.
- In depth knowledge of handling HPLC, IR, GC, AAS etc.
- Knowledge on GMP, GLP, Calibration & Validations, Drugs Rules & Regulations.
- Knowledge on stability testing.
- Knowledge on national health policy.
- Ability to work under stress.
Educational Requirements :
- Master of Science (MSc) in Pharmacy
- Must have Pharmacist registration
Experience Requirements :
- 5 to 10 years
Additional Requirements :
- Age 30 to 45 years
Compensation & Other Benefits :
As per company policy
How to Apply
Primary Information
Published on:
05/08/2024
Vacancy:
01
Employment Status:
Full-time
Gender:
Male
Age:
Age 30 to 45 years
Job Location:
Factory
Salary:
Negotiable
Application Deadline:
06/06/2024