Company Name: Nipa Pharmaceuticals Ltd.
Job Title: Manager - QA
Job Type: Full Time
Job Category: Medical/Pharma
Deadline: 25 Jan,2017
M.Sc. in Chemistry/ Biochemistry/ Pharmacy/ Applied Chemistry from any recognized university with excellent academic record.
- 8 to 12 year(s)
- The applicants should have experience in the following area(s):
- The applicants should have experience in the following business area(s):
- Age 35 to 45 year(s)
- Only males are allowed to apply.
- 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
- Ability to work under stress.
- A highly competitive and attractive compensation package along with bright career path and excellent work environment is waiting for the really deserving candidate.
Applicant must enclose his/her Photograph with CV.
Application Deadline : Jan 25, 2017
Company InformationNipa Pharmaceuticals Ltd. Address : 10/16 Iqbal Road, Block-A, Mohammadpur, Dhaka-1207, Bangladesh Web : www.nipapharma.com
Job Description / Responsibility
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.