Zydus Cadila, a leading Indian Pharmaceutical company is a fully integrated, global healthcare provider. With in-depth domain expertise in the field of healthcare, it has strong capabilities across the spectrum of the pharmaceutical value chain.
Senior Executive - Development QA (API)
The Incumbent should have Ph.D or M.Sc (preferably Analytical Chemistry) / M Pharm with 4 to 6 years of relevant experience In Analytical Method Validation data review of HPLC, GC, LCMS / GCMS / ICPMS, XRD. Hand on experience of Analytical method transfer activity. Hand on experience of Calibration and Audit trails of Analytical instrument. Knowledge of ICIH guideline - GMP, Analytical method validation. Analytical method Transfer, Spec design. Force Degradation.
Quality Assurance (API)
The incumbent should have M.Sc / M.Pharm / B.Pharm with 1 to 8 years and have worked in regulated plants with EU, MHRA, US FDA approvals. Should have relevant experience / exposure In Qualification, Validation, QMS. Batch Release, Audit & Compliance, Qualification, IPQA, Validation, Investigation and Analytical QA areas. Responsible for Preparation/review of Deviation, Change Control, Market Complaints, OOS, OOT, Product. To conduct investigation and Root Cause Analysis to design the CAPA for the failures occurred in the plant. Ensure compliance (GMP, GXP) with appropriate SOP's In line with Practice & various Health Regulatory Authorities and guidelines. Plant round for the verification of GMP Practices and compliance of SOPs. Review of documents submitted In QA like Finished products reports. Raw Material reports. Intermediates reports, Analytical method validation.
Regulatory Affairs (API)
The Incumbent should have M.Sc / M.Pharm with 8 to 9 years of relevant experience in Regulatory Affairs. Preparation of US DMF, CLP in eCTD and preparation of ASMF. Should have thorough knowledge in ICH and other regulatory guidelines. Thorough knowledge of control strategy is essential. Hands on experience for query response for the relevant competitive authority (US FDA). Review and compilation of data required for regulatory submissions to various regulatory authorities. Response to the customer queries with consultation with Manager Regulatory affairs. Update the knowledge as per recent guidelines to cater the requirement while compilation of regulatory submissions.
Date : August 07, 2021 (Saturday)
Time : 10 am to 4 pm
Venue : ZYDUS API Park Cadila Helathcare Ltd
Behind Bright Day CBSE School Next to Kishan Classic
Vasna Bhayli Canal Road Vadodara
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