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More than 10 years handover experience in Quality Assurance in the field of Pharmaceuticals for API (synthetic & Generic), Sterile API (Oncology & Betalactums), Liquid, Dry powder, & Lyophilized Injectable.
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Trained under GMP Consultant (Trained QP& ISO auditor) for excellent understanding of EU-GMP, WHO, TFDA guidelines, and complete knowledge of FDA - 21CFR 210, 21CFR 211 and ICH guidelines (Q9 Quality Risk Assessment).
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Expertise in Regulatory Audits & Compliance – Participate in Regulatory Audits (as Auditee) and writing FDA 483 Response / EU Audit Response and other Customer Audits.
Quality Management Systems - QMS elements like Customer Complaints, Investigations, Deviations, CAPA, Change Control, & Internal Audits (Review, verify root cause, approval, Closure).
Qualifications & Validations – Vendor/Supplier Qualification, Production/Utilities/Laboratory equipment Qualification along with analytical method validation, media fill simulation, sterilization method validation, manufacturing process validation and cleaning validations (Review validation protocols & reports, Preparation of Quality Risk Assessment)
公司介紹
HLC管理
