Site Head Quality Control

1 day ago


Hyderabad, India Profile HR Consultants Pvt Ltd. Full time

CLIENT : Integrated CRO with API Process Development for NCEs and Peptides,present in over 80 countries. KEY DELIVERABLES: Head Site QC and manage investigations of product issues, laboratory incidents (LIR), OOS, OOT & OOC. Lead & oversee the review of audit trails (CDS & Non-CDS) to ensure cGMP & regulatory compliance. Supervise LIMS activities, including data review, migration, & error resolution. Direct planning & execution of batch releases for raw materials, intermediates, & finished products using LIMS & SAP. Plan & execute finished products, intermediate testing, and stability studies. Conduct & oversee internal audits, review compliance reports, & drive resolution. Review, prepare, & ensure adherence to SOPs; monitor & guide the analytical team. Manage change control processes, SOP revisions, Audit based revision & new SOP initiation. Incumbent profile: M.Sc (Chemistry) with 15 years experience in Quality Control - Peptides. Strong exposer in Stability section, ie, Stability sample management,monitoring of analysis, validation batch evaluation and co-ordinate with regulatory requirements 21 CFR Compliance activity in laboratory. Annual Compensation: 20-25LPA Queries: Anoop Sinha-CEO, PROFILE HR CONSULTANTS PVT LTD Cell-



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