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14/12 Manjusha Mohil
Owner at Life Solutions Company

Views:781 Applications:62 Rec. Actions:Recruiter Actions:0

Quality Head - Injectables Pharma (10-20 yrs)

Roorkee/Uttarakhand Job Code: 16802

Responsible for authorization of written procedures and other documents, including amendments for the same.

- To monitoring and control of the manufacturing environment including hygiene in the plant.

- Review process validation and calibration of analytical apparatus.

- To ensure proper Training, including the application and principles of quality assurance.

- Accord approval and monitoring of suppliers of materials and contract manufacturers;

- To ensure proper storage conditions for materials and products.

- To ensure proper retention of official records.

- To monitor the compliance as per GMP requirements;

- To ensure proper inspection, investigation, and taking of samples, in order to monitor factors that may affect product quality.

- Check and sign of batch manufacturing records.

- Approval of batch release certificate.

- To fulfill customer requirement as and when required.

- Reviewing of annual product review data & update.

- Review of daily observation report of QA chemists.

- Approval of shift schedule completion of different party requirements & communication.

- IPQA report review and mail compliance to Management on a daily basis

- Customer audit compliance within the required timeframe with follow up from concern departments.

- Programming internal audit & self-inspection (as per schedule)

- Handling change control, deviation and market complaint.

- Artwork and shade cards approval authority.

- To stop the line in case of any deviation observed in any stage of production till its rectification.

- To check online documents at any time at all the stages of production.

- To question the shift chemist about the deviation

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