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CQV Package lead | Cqv Package Lead in Job Job | 7298024463

This listing was posted on iSmartRecruit.

CQV Package lead

Location:
Bangalore
Description:

Job:CQV Package lead Location:Bangalore Experience:10-15 Years Job Description: Project management skills regarding C&Q, facilitating board meetings to review status, timelines, quality, challenges, generating reports for steering group, understanding to evaluate risk and its mitigation strategies. Thrives in a fast-paced environment with many concurrent tasks. Need to train the team in performing the site activities and handling different stakeholders. Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns. Hands on experience in planning / directing C&Q activities of process equipment’s qualification. Should have hands on experience in validation deliverables like URS, design review, P&IDs, FAT, SAT, IQ, OQ, PQs, protocols, and reports generation & execution, etc. Should have good communication and collaboration skills enabling interaction with many stakeholders from different functions and cultures. Bachelor’s or master’s degree in a relevant science, engineering, or pharmaceutical field. 10 years experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally you will already have experience in equipment qualification. Should have knowledge with recent edition of ISPE C&Q and GAMP and regulatory guidelines USFDA, EU GMP, Annexure 11 & 21 CFR 11 and ICH guidelines.
Posted:
June 10 on iSmartRecruit
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