Senior Executive/Assistant Manager Quality
- Galentic Pharma
- 7 to 12 Yrs
- Mumbai
- 3 years ago
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Job Description
Job position: Senior Executive/Assistant Manager
Department: Quality Assurance (Development QA)
Qualification: M.Pharm/M.Sc
Experience: 7-10 years
Job Location - MUMBAI
Job responsibilities:
- Responsible for supporting the Development Quality Assurance team, for the Research and Development activities at R&D level.
- Review of Development documents and process for IND, NDA, and ANDA including Analytical Methods and PDR.
- Implement the Development Quality System based on Quality by Design concept.
- Develop, implement, track, review, approve elements of the Quality Management System including but not limited to SOPs, Change Control, Deviations, Incidents, CAPAs and Product Complaints.
- Facilitate for performing Risk Assessment and monitoring of proposed mitigation plans.
- Responsible for implementation of QbD tools wherever feasible in product development process.
- Responsible for review of R&D lab notebook/lab trial review.
- To verify the activities as being performed as per cGMP and GLP.
- Responsible for preparation/review of exhibit batch MFR and MPR.
- Responsible for review of stability study protocol at R&D level.
- Co-ordinate between R&D and RA department for document filing.
- Any other duties as per organizational requirements.
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Bio Tech / R&D / Scientist
Functional Area: Not Applicable
Role/Responsibilies: Senior Executive/Assistant Manager Quality
Contact Details:
Company: Galentic Pharma IndiaLocation(s): Mumbai
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