Incorporated in the year 1994, Syngene International is one of India’s premier 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.
Job Title : Executive/senior Executive-biologics QA
Eligiblity : M.sc Biochemistry
Experience : 2 – 3 Years
Location : Bengaluru/Bangalore
No of Openings : 1
Job Description
- Help/Support in creation of departmental GMP systems and procedures.
- Facilitate the coordination between Production, QA and QC departments.
- Support manufacturing by using modern science and risk based quality systems by performing GMP risk assessments, author GMP related documents.
- Liaise with production leads and Process Engineering for systems validation (IQ,OQ, PQ) and cleaning validation / verification.
- Support activities for anytime audit readiness of the facility.
- Support in GMP audits by representing manufacturing. Facilitate, track and implement identified CAPAs.
- BMR review at time of preparation. Post execution BMR review.
- Preparation /Review of General validation protocols and reports, performance qualification documents.
- Responsible for issuance of all the operations SOP/EOP/IOP annexures to production personnel.
Desired Profile
Candidates who have experience in Biologics manufacturing and interested in GMP documentation and QA role can also apply.
