Walk-in for Officer to Manager Vaccines in pune on 15th May (9 Am to 5 Pm) @ Zydus Cadila
Job Description
Quality Assurance (Vaccine): M.Sc. (Biotech / Microbiology) with 2-10 years of experience in Quality Assurance (QA) of vaccines/sterile injectables. Should also have experience in QA operations/ QMS/ validation/ qualification/ documentation/ compliance.
Quality Control (Vaccine): M.Sc. (Biotech / Microbiology / Chemistry) with 2-10 years of experience in Quality Control (QC) of vaccines/sterile injectables. Should have experience in QC Finished product testing / raw material testing / microbiological testing.
Officer to Manager Corporate Research Quality Assurance
Clinical Trials: M.Sc. / M.Pharm with 5 12 years of experience in QA. Should carry experience of investigator site audits, review of SOPs, clinical trial study protocols (Phase I IV), Reports, raw data like Informed Consent Forms, Medical Screening records, patient diaries, Clinical Case Record Forms, SMF, TMF; review of Data Management Plan, Statistical Analysis Plan, Conduct vendor audits & Host Regulatory inspections.
Clinical (BA / BE, Phase I and Clinical Pathology): M.Sc. / M.Pharm with 3 - 5 years of experience in QA. Should carry experience of conducting various clinical audits (Study based, facility based) of BA/BE & Phase I studies in GCP sections (Clinical research, Clinical Pathology Lab, PK/Stat); review of SOPs, Study protocols, IBs, study data (ICFs, Screening records, TMFs etc.), study reports, change controls, deviations, amendments, manuals, validation records; Conduct of vendor audits and host regulatory inspections.
Non Clinical: M.Sc. / M.Pharm with 8 - 12 years of experience in QA (GLP). Should carry experience of review of SOPs, Study plan, final study reports; Conduct of Study based, process based & Facility based audits; Host regulatory inspections; be able to perform trend analysis of Audit findings, analyze and track Deviations, Non-conformances, Out of Specification, Change Controls and CAPA; conduct Quality Review Meetings.
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