Sr. Manager - Quality Assurance -Pharma

Job description

Position Summary

Sr. Manager - Quality Assurance -Pharma

Quality Assurance role will be responsible for leading and managing Quality Assurance operations- activities. QA operations are responsible for supporting GMP manufacturing operations and process development activities. This position will be responsible for QA oversight of manufacturing organizations and for review of executed batch records, deviations, analytical data, stability data, and other GMP documents and reports. And also would have Strong Knowledge of pharma GMP, Regulatory, Audit, Compliances, QA, Initiations, Development, Review, Approvals & maintenance of quality systems modules, implementation of CAPAs, Market Compliances, Regulatory & Customer Audit.

Key Accountabilities :

- Responsible for implementation of Quality Management System as per regulatory requirements.

- Over all responsible for the Management of QMS related activities

- Management of the Continual Improvement of the Systems, Gathering and trending of quality related data, Data Storage, Product Quality Review Process, Risk Management Process for the Corrective and Preventive Action System.

- Accountable for the elimination of the Data integrity events and implementation of the SOP and policy.

- Review, Approval, and compliance of Site Master File.

- Evaluate & approval of master documents pertaining to various departments.

- Responsible for approval of all master documents.

- Accountable for Control Sample Management and Stability Management.

- Responsible for implementation of QA systems for ensuring that compliance as per sops.

- Accountable for implementation of the Quality Risk Management.

- Accountable for Annual Product Quality Review programme.

- Timely ready for any external & internal audits

- Preparation of the compliance report following the external audit and corporate audit and ensure compliance

- Responsible for cGMP related Training.

- Prepare & accountable for the handling of the training program.

- Ensuring timely evaluation, approval, and closure of incidence, deviations, OOS, OOT, CAPA and change controls.

- Management of quality management system for OSD (Immunosuppressant / General) and injectable blocks.

- Responsible for providing timely support to external and internal customers as per requirement.

- To discuss warning letters, GMP trends, other sites audit report, Major incidences with stack holder.

- To Share the Monthly report to CQA, Head quality, and other department heads.

- Review, evaluation, and approval of Document on behalf of QA Head / Head Quality in his absence at the location.

- Responsible for approval of analytical documents as per requirements.

- To follow cGMP practices and authenticity of the information recorded.

- Responsible for Head Quality Assurance activities

- Responsible for review and approval of equipment qualification/ requalification/ validation protocols, a compilation of summary reports of the injectable block.

Requirement

- B Pharma / M Pharma with 10 - 15 years of experience in Quality Assurance.

- Good knowledge on GMP, OOS OOT audits, investigations, compliance, quality management.

- Good People management skills

- Stakeholder management

- Regulatory Audit management with MHRA, TGA, ANVISA, EU, Health Canada & USFDA.

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