We invite candidates for our *Quality Assurance* department of *Zydus Biologics Unit* based at *Biotech Park, Ahmedabad*
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We are looking for M.Sc.(Biotechnology)/M.Sc. (Biochemistry)/M.Sc. (Microbiology)/ B.Pharm / M.Pharm with 1 to 7 years of hands on experience for below mentioned openings:
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*Officer / Executive / Senior Executive*
*QA Oversight manufacturing (IPQA): Code 1*
Should be responsible for QA Oversight (IPQA) related activities for Drug substance manufacturing along with handling of process validations, cleaning validations OOS, change control, deviation, investigation, CAPA and QMS activities.
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*Qualification/Validation: Code 2*
Should be responsible for Equipment Qualifications (Fermenter, Bioreactor, Media/buffer preparation Vessels, Autoclave etc.), Utility Qualifications, HVAC, Water System, Protocol preparation and its compilations. Should be responsible for Media fill activities, protocol & BMR preparation/review.
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*QMS: Code 3*
Should be responsible for QMS related activities like Failure investigation, Quality events handling and investigations, change control, market complaint, conducting self-inspection, APQR, OOS/OOT trending etc.
*Analytical QA: Code 4*
Shouldld be responsible for review of Analytical Reports, Stability Protocols and data sheets, Investigation, Review and disposition of OOS, OOT & OOC results, handling of Incidents, Deviations, and Change Controls in the Laboratory along with review of all method transfer / method validation, types of Qualification documents. Review and approval of all Lab Standard Operating Procedures.
*Document control/Documentation cell: Code 5*
Should be responsible for handling and control of various GMP documents (Issuance / control / retrieval / archival). Responsible to retain all master/executed documents in document storage room with adequate indexing and keep ready documents for the regulatory audit(s)
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For all the positions, candidate having exposure to regulatory requirement of documentation and cGMP/GLP is essential.
Interested candidates may send their updated CV along with current and expected CTC to *niravsuthar@zyduscabdila.com*
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