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 Reporting to Functionally to MD/CEO and Administratively to Head-Operations
