Role & responsibilities Job responsibilities comprise carrying out of Quality Assurance functions in day-to-day activities. JOB RESPONSIBILTY 1. Responsible for review, approvals and close outs of change controls, deviations, CAPA, incident reports and any other quality system documents 2. Develop, manage and improve Quality Systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of CGxP activities 3. Review and approvals of analytical and formulation development Master documents. 4. Review and approval of analytical activities protocols and reports 5. Submitting whole set of documents required for regulatory submissions for new products 6. Supporting for any regulatory queries from QA perspective 7. Review and approval of validation, qualifications protocols and reports, 8. Monitoring day to day activities in Analytical development and Formulation development in compliance to the GMP 9. Preparation, review and approval of SOPs 10. Conducting training on SOPs, quality management systems and GMP in all aspects including procedural updates 11. Control of documents includes documents storage, issuance, distribution, retrieval and destruction 12. Performing vendor audits of API and Excipients (where necessary) and handling of all activities related to vendor audits 13. Conduct periodic audits of CMOs and Althera affiliate facilities. Participate in the vendor Qualification programme as and when needed. 14. Review and approve change control initiated at CMOs and co-ordination with European QA, RA aid customers and keep track till all the relevant activities are completed 15. Planning and conducting of self-inspection, preparing and sending self-inspection reports to concerned departments. Verifying the self-inspection compliance report for correctness and completion 16. Oversight and coordination with the Contract Manufacturing Organization (CMOs) on batches manufacturing activities as well Quality Management functions for Althera products 17. Coordination with the European QA team on supplying necessary QMS documents as required 18. Responsible for review, approvals and close outs of deviations, CAPA, OOS, OOT and incident reports raised by the CMOs. Timely review of effectiveness of CAP As. 19. Participate in investigations at the CMOs where necessary, review and ensure the investigations are conducted in line with the current regulatory expectations. 20. Applying risk management tools wherever applicable in accordance with current regulatory requirements 21. Handling of Market complaints and to co-ordinate with respective CMOs to get the investigation done on timely manner with appropriate root causes and CAPAs identified. 22. Track all the QMS status of Althera products at CMOs are timely concluded, and reports are shared 23. Coordinate with CMOs in any Regulatory and customer audits at their site, track all the observations and the CAPAs are completed timely as per the commitment. 24. Review and approve of CMOs validation and master documents (BMRs, BPRs, MFR, PVPs, PVRs etc) and Protocols (Validation, Qualification, cleaning, stability etc) 25. Oversee, support and coordinate with Althera affiliate manufacturing and Testing sites and the RnD site. 26. Preparation, Review of the PQRs for Althera products. 27. Ensure quality / technical agreements with contract manufacturing organizations (CMOs)are available and updated within timelines. Preferred candidate profile Perks and benefits best in the industry
