Group Leader Quality Assurance require at Good Health Pharmaceuticals Pvt.Ltd

Good Health Pharmaceuticals Pvt.Ltd is a specialty pharma company focused on development of niche products with clear clinical and commercial advantage. Currently undertaking development of technically complex parenteral products for 505 b 2 submissions. Company has filed 9 patents in short span and many more in pipeline.

Post : Group Leader QA - Developmental (DQA)-01

Job Responsibilities & Required Skills
Group Leader of DQA will be entirely responsible R&D compliance to "GLP" norms of USFDA. Duties involve not restricted to
1. Ensure systems, procedures, facility are aligned to current requirements of FDA for R&D operations.
2. Writing SOP's/Guidelines/Operating instructions.
3. Write validation protocols for analytical procedures/stability testing/developmental work in line with ICH/FDA/USP norms.
4. Trian employees from FD/AD/QA for currents of GxP's.
5. Ensure SOP's/Guidelines are strictly followed. Logbooks are routinely entered.
6. Ensure experimental details are recorded in lab note books.
7. Review method validation reports, product development reports, stability reports.
8. Apply for local and federal licenses for development and testing of range of products.
6. Coordinate with CMO for Tech transfer and BE manufacturing.

Candidate Profile
M.Pharm/M.Sc with 4-8 years experience in quality assurance department connected with Development center. Person with quality assurance experience connected to commercial production of pharma finished product would be considered if he has basic understanding of product development.

Additional Information
Experience : 4-8 years
Qualification : M.Pharm/M.Sc
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : DQA
End Date : 10th December, 2020