Zydus Biologics-Opportunities in Quality Assurance /USP/DSP-Production Department
Opportunities in Quality Assurance / USP/DSP – Production Department of Zydus Biologics, Biotech Park, Ahmedabad
Position: Senior Executive/Assistant Manager (Candidate must have 4 to 8 years exp.)
Quality Assurance
(M.Sc Biotech/B.Pharm/M.Pharm)1. Validation: Code QA1
Must have experience in Equipment Qualifications (Autoclave, Tunnel etc), Process validations, Cleaning Validation, Utility Qualifications, HVAC, Water System, Protocol preparation and its compilations. Should be responsible for Media fill activities, protocol & BMR preparation
2. QMS: Code QA2
Must have experience in QMS related activities like Failure investigation, Quality events handling and investigations, change control, APQR, OOS/OOT trending etc.
3. Analytical QA: Code QA3
Must have experience in review of Analytical Reports, Stability Protocols and data sheets, Investigation, Review and disposition of OOS, OOT, OOG & OOE results, handling of Incidents, Deviations, and Change Controls in the Laboratory along with review of all types of Qualification documents. Review and approval of all Lab Standard Operating Procedures.
4. QA Oversight manufacturing (IPQA): Code QA4
Must have experience in 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.
Dy. Manager/Associate Manager (Candidate must have 9 to 12 years exp.)
1. USP & DSP – Production (M.Sc Biotech / B.Tech Biotech / B.E Biotech)
USP Production (Code P1)
Must have experience in Aseptic handling of mammalian cell culture, Media/feed preparation and its filtration, Readiness of bioreactor and associated vessels (CIP, FIT, PHT, SIP), Operation of bioreactor, Readiness and operation of centrifuge, Clarification of cells, Manufacturing of monoclonal antibodies/ bio therapeutic protein
DSP Production (Code P2) Must have experience in downstream purification process for recombinant products, TFF system, chromatography system, depth filtration procedures, CIP/SIP of the equipment.
For all above positions, candidate having exposure to regulatory requirement of documentation and cGMP/GLP is essential.
Candidate from Biotech, Vaccine & Injectable Pharma plants will be preferable who have knowledge of process equipment’s like as Autoclaves, Bio-reactors, fermenters, Lyophilizes etc.
Preference will be given to those who matches with above mentioned requirement and submit their CVs based on the mentioned code no. along with current and expected CTC to
ruchi.lal@zyduslife.com by on or before 20th Dec’2022.
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