Company Name: Nipa Pharmaceuticals Ltd.
Job Title: Manager - QC
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
- Knowledge on national health policy.
- 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
Managing function of quality control system
GLP and GMP compliance
Validations, analysis of raw materials and finished products
Managing laboratory team and determining work priorities, daily planning of analysis and ensure analysis of raw materials
Intermediates, in-process control, Control over day-to-day activities of QC Department with chemical laboratory, Instrumentation and microbiology. Communication with relevant departments etc.
Organize and monitor 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.
Review and authorize in process Checking, BMR, BPR and SOP's preparation and checking during manufacturing of products.
Review and authorize 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 QC/Production/Engineering/Ware house personnel.
Maintain and authorize 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.
Review and authorize sampling &analysis of Raw Materials, Packaging Materials, Finished Products and Water.
Responsible to handle 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.
Review and authorizecalibration of all sophisticated QC equipments.
Responsible to handle of OOS with proper investigation.
Review and authorizemaintain GLP & housekeeping and make corrective measures for any deviation.