Owner at Life Solutions Company
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Quality Head - Injectables Pharma (10-20 yrs)
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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