Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post: Manager QA
Job Description:
- Ensure adherence of GMP.
- To review and approve Site master file of Pilot Plant.
- To review and approve Validation Master Plan of Pilot Plant.
- To review and approve Master & Executed Batch records.
- To review and approve standard operating procedures (SOP).
- To perform and review self-inspection.
- Support the investigations for Change control, deviations, Corrective action preventive action (CAPA).
- Evaluate, approve & coordinate the closure of Change control, deviations & CAPA within the stipulated timeline as per SOP.
- To evaluate the root cause and CAPA with respect to their adequacy and correctness.
- QA monitoring, Approval and Release of GMP batches for further studies.
- To organize in-house I external trainings for associates as per the job requirements.
- Upgrade quality system as per EU GMP standard with the help of Global development QA.
- To prepare and review Corporate Quality Assurance departmental standard operating procedures (SOP).
- To ensure relevant EQD documents are reviewed and the Affiliate SOPs are aligned accordingly with the clear understanding on the justifications, if the EQD documents are not followed directly.
Responsibilitiesat PR&D:
- Ensure adherence of GMP.
- To review and approve standard operating procedures (SOP).
- To review and approve MMDs, MPDs, STPs and SPECs.
- To review and approve Analytical Method Validation Protocol & Reports
- To review and approve Stability Protocol & Stability Reports.
- To review and approve Equipment Qualification protocols & Reports.
- To perform and review self-inspection.
- Support the investigations for Change control, deviations, OOS, Corrective action preventive action (CAPA).
- Evaluate, approve & coordinate the closure of Change control, deviations, OOS & CAPA within the stipulated timeline as per SOP.
- To evaluate the root cause and CAPA with respect to their adequacy and correctness.
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Others:
- To prepare and review Corporate Quality Assurance departmental standard operating procedures (SOP).
- To prepare and review Corporate Quality Assurance guidelines.
- To prepare Gap Assessment of Quality Systems at Pilot Plant, PR&D and HO against EQD's and alignment of the same.
- To support SOUD (Documentation, Review, Implementation and maintenance) for Pilot Plant and PR&D
- To support ISOTrain (Documentation, Review, Implementation and maintenance) Pilot Plant and PR&D
- To Support Artwork review
- To organize in-house I external trainings for associates as per the job requirements.
- Guidance to SOILD implementation for all master documents
- Any other responsibility that may be assigned from time to time.
Additional Information:
Location: Mumbai
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 28th November, 2017
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