Description

To ensure compliance of plant as per cGMP requirements laid down by various international and national regulatory bodies. To update quality systems & procedures in accordance with the current regulatory expectations and guidelines. To ensure successful audits by various international / national regulatory bodies and compliance. To ensure product Licenses permission are maintained/ renewed timely for all products manufactured at the facility.

- To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and international quality standards in main Pharma.
- To ensure that the product meets the defined standards for strengths, identity, safety, purity and quality by various system-driven approaches.
- Create and maintain Quality Systems that are in compliance with various quality standards and regulations that mainly include FDA Regulations.
- Ensuring timely reporting of OOS, OOT, FAR and Deviations, adequate root cause investigations and compliance to scheduling and completion of resulting action items.
- To ensure timely review and approval of change controls, deviations, OOS, OOT, CAPA and QMS documents.
- To hold the manufacturing and packaging processes, if the norms are not followed and work is compromised as per Positive Manufacturing Practices and the Standard Operating Procedures requirements.




- Monitoring of Quality KPI &
- Quality council meetings.
- Planning and scheduling of compliance audit at sites for all time readiness of regulatory audits.
- To review and update quality system and procedure of Warehouse, production, QA &
- QC to meet the international / national CGMP requirements.
- To ensure smooth technology transfer of new product to plant level sign the Technical Agreement with customers.
- Authorizations of SOPs, MMD I, BPR, Qualification &
- Validation protocol & reports, Quality Manual, VMP, SMF,QMS, PQR Validation documents and other Master documents.
- To ensure cGMP related training program for all concerned man power in coordination with HR.
- To qualify vendor of Raw &
- Packaging Materials.
- To highlight and resolve quality related issues at manufacturing locations.
- To ensure implementation of written procedures and guidelines.
- To ensure functioning and related activities of the RQA department at F&D.;
- Responsible for Approval of Certificate of Conformance.
- Responsible for batch disposition decision and Batch release documents.
- Responsible for approval and authorization of Quality Documents viz.

Quality

Agreements, Declaration, submission documents.

- To ensure completion of any additional task assigned by the senior management, if any.

📌 Senior General Manager (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka