Senior Manager / AGM - Quality Compliance

1. Quality Compliance Oversight, Quality Metrics and Management of quality compliance:

a. Responsible for monitoring the site compliance at all Swiss Garnier units and reporting to Corporate Quality on day today basis.

b. Managing quality metrics for Quality Units and compliance status of all Swiss Garnier Units and support on NSQ, follow up, coordination with site QA and CQA / RA getting investigation report, concurrence / approval from customer & regulatory authorities on investigation and CAPA acceptance and implementation.

2. Quality Investigation & CAPA Management

a. Monitor all the quality failures at all units and investigate by collaborating with CFT at Units to find out the root cause and CAPA.

b. Proactively review the process and system followed at Units identify the risks and implement the CAPA at all Units

3. Regulatory compliance management: Responsible to Co-ordinate with the Customers and site on any regulatory document queries, Nitrosamine / Elemental impurities queries and any other regulatory requirements. Also connecting customer and vendors team in quality and technical aspects and ensure assessments are provided on time.

4. Regulatory compliance management: Responsible for Monitoring of Compendial/ Pharmacopeial revisions or any addition of new monographs, which impacts our system and procedure and ensuring the changes implemented in License, Artwork labelling, specification, testing methods, BMR, BPR, MMR and procedures at all sites.

5. Quality Council / management review meeting: Responsible for collecting / compiling the data from sites for Quality council meeting. Also coordinating with sites for weekly / monthly quality reports and compiling to present to management.

6. Implementation and management of eQMS /eDMS: Responsible to implement and manage all quality management system & document management system across Units including compliance to QTA, Quality periodic report to management by co-ordination with site.

7. Training management: Responsible to monitor the training program for SG group of companies and provide periodic GMP and specific training.

8. Management of Corporate Quality Audit and Customers Audit: Responsible for designing, planning, execution of the corporate Quality audits at all units of Swiss Garnier and ensure response with appropriate CAPA received and tracked to closure.

9. Management of Customers Audit at S.G Units & CAPA Management: Responsible for co-ordination with S.G units for inspection readiness process and support unit team during inspection and to ensure compliance. Also ensure CAPA response provided is adequate and implemented across all Swiss Garnier Units and tracked to closure.

10. QMS: Responsible for preparation, review of quality management system procedures associated with corporate quality and Swiss Garnier Units and coordinate with unit team for implementation of QMS procedures and Customer requirements.

11. Supplier Quality Management: Manage centralized vendor qualification and Audit activity. Responsible for Vendor qualification for all materials supplied to Swiss Garnier Units. Review and Monitor the Qualification documents / credential of API, excipient and packing material vendors. Also, to complete Successful Qualification report. Periodic updation of Qualification documents to maintain the Compliance. Responsible for Review the proposal for alternate vendor source documents and evaluate the feasibility and qualification documents of proposed vendors.

12. Quality management of Service providers: Management of centralized Contract testing lab (CTL) / service provider audit and Qualification activity. Responsible for review and monitoring, follow-up on the Qualification documents / credential of Contract testing lab / service provider and also to complete Successful Qualification report. Periodic updation of Qualification documents to maintain the Compliance.

13. Management of Quality Technical agreements (QTAs): Centrally manage all 4 units QTA with Customers. Also manage QTA with all materials vendors, contract testing Labs and service providers for all units of Swiss Garnier. Over all responsible for review, monitor and revise Quality Technical Agreements between Customer, materials Vendors (RM & PM) and Contract testing labs / service providers.

14. Audit management: Scheduling and Performing Qualification audit and periodic audit, follow-up on the response, until ensuring satisfactory response and CAPA implementation from auditee end.