Zydus Biologics – We are recruiting in USP/DSP – Production / Quality Assurance / Quality Control based at Ahmedabad
We are recruiting in USP/DSP – Production / Quality Assurance / Quality Control of Zydus Biologics (Zydus Biotech Park) based at Ahmedabad
Executive / Senior Executive / Assistant Manager / Dy. Manager
1. USP & DSP – Production (M.Sc Biotech / B.Tech Biotech / B.E Biotech / M.Tech Biotech)
DSP Production: Candidate must have 2 to 14 years exp. in downstream purification process for recombinant products, TFF system, chromatography system, depth filtration procedures, CIP/SIP of the equipment.
2. Quality Assurance (M.Sc Biotech/B.Pharm/M.Pharm ):
USP Production: Candidate must have 2 to 14 years exp. 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
QA Oversight manufacturing (IPQA) Candidate must have 02 to 04 Years exp. with hands on 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.
QMS Candidate must have 06 to 08 Years exp. with hands on experience in QMS related activities like Failure investigation, Quality events handling and investigations, change control, market complaint, conducting self-inspection, APQR, OOS/OOT trending etc.
Documentation cell Candidate must have 06 to 08 Years exp. with hands of experience in 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)
Assistant Manager / Dy. Manager / Associate Manager
3. QC Chemical (M.Sc Biotech) Candidate must have 08 to 12 years exp. with hands on experience in Reviewing of Protein analysis/ Instrumentation, Molecular biology, Bioassay, GLP activity related documents. Responsible to review all the documents, test reports, calibration reports records, logbooks, and formats in relation to the activity of Protein analysis/ Instrumentation, Molecular biology, Bioassay, GLP and filling. To carry out investigation of Incident, Deviation and OOS generated during laboratory analysis. To prepare and review ATR and COA for the batch data.
For all above positions, candidate having exposure to regulatory requirement of documentation and cGMP/GLP is essential.
Also, please note preference will be given to those who matches with above mentioned requirement.
Interested candidates may send their updated CV along with current and expected CTC to [email protected] by on or before 30th April 2022
