Senior Executive- R&D QA
13 hours ago
Job Responsibilities:
Review of Analytical Method Validations/ Verifications protocol/ reports
Review of Analytical Method Transfer protocol/ reports
Review & release of Reference standard characterization data
Review of R&D data and Lab note book for regulatory submission
Review of Instrument/Equipment Qualification & Calibration reports
Review of CSV (Software Qualification) documents (Protocol &Reports)
Review of DS & DP STPs (Reference standard, Raw Material, Intermediate, In process, Semi finished & Finished product).
Preparation, Review & training of CQA SOP (Related to R&D Labs)
Review of SOPs for R & D function (Analytical Research Laboratory, DDRL (Pilot Laboratory), Engineering Department.
Investigation & Review of QMS events & related CAPA
Review of Change controls
Conduct Internal audits & Walkthrough rounds of R&D Labs
Review of Pilot BE/ Assessment Batches manufacturing documents (BMR/BPR)
Review of Equipment performance qualification
Review of AHU qualification
Issuance, archival & retrieval of SOP related formats, registers and logbooks and documents (Protocol/ reports etc.)
Should have knowledge of handling electronic platform (TWD, S4 HANA, LIMS, DMS etc)
Should have well aware about regulatory Guidelines and 21 CFR part 11 requirements
Assist to continuous review and updating of existing procedures and systems to comply with current regulatory guidance's, CGMP and USV company policies.
Assist to implement current Pharmacopoeial updates and Regulatory guidance requirements.
To co-ordinate with different functions at sites, R&D Labs and other corporate functions for smooth functioning of operational activities.
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