Assistant Manager- QC/PD

Job Description

Title: Assistant Manager- QC/PD

Company Name: Nipa Pharmaceuticals Ltd.

Vacancy: --

Age: 30 to 50 years

Job Location: Dhaka

Salary: Negotiable

Experience:

• 3 to 5 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Master of Pharmacy (M.Pharm) in Pharmacy

• 3 to 5 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Age 30 to 50 years

• 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.
• Preparation & standardization of volumetric solution, secondary working standards from reference standard etc.
• Development and validation of analytical methods for different pharmaceutical dosage forms
• Analyzing existing products to ensure formulation meets all required standards while being cost effective
• Developing new formulation for both current and new products to achieve improved quality and reduce unnecessary cost
• Preparation of SOP for analytical instruments
• Calibration of analytical instruments
• Preparation of stability data and shelf-life documentation
• Analyze business requirements and prepare documents for process flows.
• Monitor efficient working of all projects and ensure compliance to project plan.
• Coordinate with team to resolve all issues and supervise meetings for same.
• Administer all projects and ensure completion within required timeframe.
• Monitor all aspects of products such as pricing and legal requirements.
• Maintain knowledge on all regulation issues and competitor business.