Troikaa Pharmaceuticals - General Manager - Quality Assurance

- To facilitate, establishment, monitoring and maintaining Quality Assurance function of Dehradun Plant

- To collaborate with cross functional management in developing and updating policies and procedures ensuring GMP/Quality compliance

- To facilitate all time readiness for internal and external audits to ensure compliance and to identify scope of improvement in existing system, accordingly implementation of appropriate

- Approval for batch release of finished product for commercialization

- Approval of site master file

- To approve and authorize the documents like SOPs, MCM, MCP, BMR, BPR, Qualification and validation documents, technical agreement, annual product quality review as and when required

- To approve or reject in process manufacturing, to approve finished product for commercialization and to ensure that all necessary training is carried out and the associated records evaluated prior to batch release

- To be a part of GMP/Quality to investigate, review and approve the QMS documents like change control, deviation, incident, out of specification, CAPA, quality risk assessment etc

- To monitor the post production stability studies as per the SOP for its compliance

- Responsible for handling of market complaints, product recalls and returned goods

- To ensure the qualification and maintenance of premises and system, equipment, instruments as per schedule

- To ensure that appropriate validations are done

- To ensure that the required initial and continuing training of plant personnel is carried out and adopted according to need

- To ensure monitoring and control of the environment

- Responsible for ensuring that documents control and management system is followed as per the SOP

- The Monitoring and control of storage conditions for materials and products

- Participation in management review, product quality, product process performance, quality management system and advocating continual improvement in compliance with applicable national and international regulations

- To monitor and ensure data integrity at site in coordination with respective department Heads

- To approve disposition of raw material, packing material, inprocess /semi-finished product and finished product

- To monitor and ensure laboratory compliance at site in coordination with analytical QA team

- Any other responsibility assigned by Management from time to time