Galentic Pharma (India) Pvt. Ltd – Hiring for Quality Assurance (DQA) M.Pharm / M.Sc Assistant Manager / Senior Executive – Development Quality Assurance
Galentic Pharma (India) Pvt. Ltd has been manufacturing and supplying high quality pharmaceutical products. This includes both sterile and non-sterile range. The products are exported to over 40 countries – in the private market, Government Organisations and NGOs.
Quality Assurance (DQA) opening at Galentic Pharma (India) Pvt. Ltd, Mumbai location
- Department: Quality Assurance (Development QA)
- Qualification: M.Pharm / M.Sc
- Experience: 7-10 years
- Job Location: Mumbai, Andheri East
- Job Title : Assistant Manager / Senior Executive – Development Quality Assurance
- 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.
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