Manager - QA, ACG Capsules (Quality)

3 days ago


pithampur, India ACG Full time

/Primary Responsibilities/g

Strategy & Planning
• Develop mechanism for transfer of process / technology from R&D to manufacturing site to align manufacturing QA requirement
• Develop and align quality policies, processes / procedures in-line with current Regulatory /ACG requirements to support development activities.
• Develop quality culture in development activities.
• Develop & implement robust QMS at ACG Capsules.
• Management of Third party Testing Lab.
Functional
Core
• Coordinate with manufacturing QA for process, new product transfer
• Participate in new product development / investigations
• Support for new code creations of materials.
• Review development report and ensure availability for Technology transfer.
• Coordinate for vendor qualification of Raw materials for new product.
• Ensure all changes and deviations are routed as per SOP
• Monitor Calibration / qualification of Shade Development Lab equipment and instrument.
• Ensure document control in R&D / Shade Development.
• Review and approve R&D / Shade Development SOPs
• Ensure compliance with respect to quality systems.
• Ensure training as per the schedule
• Review of specifications
• Support to vendor development activities by coordinating for user trials
• Ensure stability of new products as per ICH guidelines
• Ensure delivering quality documents in-line with current Regulatory requirements.
• Ensure timely and effectively evaluation of significant changes
• Review of Change Controls, Coordinate to various stakeholders for Change impact assessment, implementation and closure of actions in time
• Review, support for investigation & Risk assessment of Deviations.
• Periodic review of Quality matrix.
• Qualification & consolidation of Third-party analytical labs.
• To review Customers Technical Agreements
• Support for validation for roll out of new / and changes in existing QMS applications

Internal Processes
People Development
• Training to Shade Development associates for importance of QMS


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