QA Executive API

Easy HR Solution

2 - 6 years

0 Lacs

vadodara gujarat

Posted:2 days ago| Platform: Shine logo

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Skills Required

cgmp ich api sops deviations capas batch release quality systems data integrity regulatory audits documentation root cause analysis manufacturing health insurance provident fund production qc rd bmrs bprs change controls validation protocols gdp qualification validation activities internal audits vendor audits inprocess checks packaging activities day shift performance bonus yearly bonus crossfunctional teams

Work Mode

On-site

Job Type

Full Time

Job Description

The Quality Assurance (QA) Executive API (Bulk Drugs) role based in Savli, Gujarat requires a candidate with 2-5 years of experience and a qualification of B.Sc / M.Sc. As a QA Executive, your responsibilities will involve ensuring compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing. You will be responsible for preparing, reviewing, and controlling SOPs, BMRs, BPRs, change controls, deviations, and CAPAs. In addition, conducting in-process checks for manufacturing and packaging activities, handling investigations for deviations, OOS/OOT results, and supporting root cause analysis are key components of this role. You will also be involved in participating in internal audits, regulatory audits (USFDA, EU, WHO, etc.), and vendor audits. Maintaining documentation for batch release, validation protocols, and quality systems, ensuring adherence to data integrity and good documentation practices (GDP), and supporting qualification and validation activities are crucial aspects of this position. Collaboration with cross-functional teams such as Production, QC, and R&D is essential for ensuring smooth operations. This is a full-time, permanent position with benefits including health insurance and Provident Fund. The work schedule is day shift with additional perks such as performance bonus and yearly bonus. The work location is in person.,

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QA Executive API