Overview

·         To ensure efficient and effective management of Regulatory Affairs, QA & QC functions ·         Monitor regulatory environment and ensure that manufacturing practices comply with the regulatory requirements ·         Ensure strict compliance to cGMP/GLP guidelines in all areas of QC lab ·         Prepare documentation packages for submission to various overseas regulatory agencies ·         Evaluate levels of in-house regulatory compliance and prepare answers to queries from regulatory authorities ·         Encourage quality improvement programs and reduce costs of quality ·         Define goals for validation and decide on the scope of all validation exercises related to products, processes and facilities ·         Ensure timely approval of material by quality control and also to enable timely dispatch of finished products in accordance with statutory rules and regulations and customer requirement ·         Provide guidance to Training Managers and approve all cGMP/GLP training programs for technical functions ·         To review and approve all cGMP related documents ·         Conduct self-inspection audits as lead auditor and ensure the compliance to cGMP requirements ·         To approve or reject all finished products ·         To conduct vendor audits & approval of new vendors ·         To review stability study data and establish expiry or retest date ·         Implement corrective measures on the basis of quality audits, out of specification, deviation data and market complaint analysis ·         To review and approve of documents with respect to change controls, market complaints, deviations, OOS, reprocess, OOT, returns and annual product quality review ·         Approving all procedures, specifications, BPRs, laboratory control records before release ·         Should have Regulatory Affairs experience

Application Email/URL:
kiran@innovativeplacement.com
Contact No.:
9925390799