Syngene International Limited Incorporated in the year 1994, Syngene International is one of Indiapremier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities.
Eligibility and other details : Â
- Post Name:Executive & Senior Executive-QA
- Qualification: B.Tech,M.Tech with 06-09 Years of Experience
- Location: Bengaluru
- Salary:Not Disclosed by Recruiter
- No Vacancies: 01
- Selection Process : Based on Resume Received,will shortlist.
Job description:
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Responsible for handling and review of equipment qualification and validation function of the Biologics business unit. Ensuring GMP requirements while performing qualifications & validations. Ensure review and witness of qualification protocols and reports for facility/Area, equipment & clean utilities in biologics facilities and warehouse. Ensure QA validation during FAT as per qualification requirements & documentation. Ensure QA validation, assessing risk/impact on validated state during any facility, clean utilities. Support for vendor/supplier qualifications. Good communication skills for reviewing the QMS documents and tracking. Support for equipment related QMS (deviations, change controls and CAPAs). Review of SOPs related to qualifications & drawings /layouts etc. Supporting during regulatory/customer audits of Syngenes facilities.
