Job Title

Experience- 20 to 25 years Qualification- M.Sc./ M. Pharma / B. Sc. / B Pharma Location- Pithampur RESPONSIBILITIES Ensure ‘All time Readiness’ for regulatory inspections by continuous monitoring of cGMP, GLP & Regulatory norms. Ensure that systems, equipment, personnel, processes, analytical methods, cleaning method, utilities, facility etc are qualified/validated as per requirement. Review and approve all master documents and records like SOP’s, VMP, various validation protocols / reports. Master Production Records (MPR’s), Batch Production Records (BPR’s), Stability Protocol / Reports, Quality / Technical Agreements / APQR etc. Ensure that document control and document retention is followed as per SOP Perform self-inspection as per cGMP requirements and promptly reply to all inspectional observations of audits done by external agencies, customers and CQA. Ensure that all committed compliances are completed within the committed timelines. Provide prompt support to regulatory affairs by providing required reviewed data in a timely manner Review and approve qualification protocols / reports (DQ/IQ/OQ/PQ) related to Quality Control instruments, manufacturing equipment, computerized systems, utilities etc Approve/Reject the Finished API as deemed fit after necessary quality review and analytical records review. Continuously improve the existing systems / procedures as per Quality System Guidelines issued by CQA and various international guidelines including ICH. Prepare, coordinate and execute training schedule related to cGMP, GLP and SOP. Ensure that all stability studies are carried out as per SOP/protocol and accordingly the shelf life of the marketed product is monitored on a continuous basis. Review, approve / reject and close all Change Control / Deviation / records and ensure that required Corrective / Preventive actions are executed as identified in the concerned record. Investigate Out of specification results, Market Complaints and deviations effectively, approve the CAPA and ensure that identified Corrective & Preventive actions are executed. Formalize a system for quality risk identification / categorization and its mitigation. Review and ensure that the preventive maintenance and calibration schedules are adhered to. DESIRED SKILLS Should have adequate experience of facing various regulatory Inspections like USFDA, MHRA, EMA, TGA etc. Adequate experience of auditing API and Intermediate / KSM vendors. Experience of working in API unit would be preferred. Very good functional knowledge and application. Proactive approach to internal and external queries. Managing multiple stakeholders. Should hold high standards of business ethics. Excellent communication skills and decision-making skills.