Manager - R&D QA & QMS, ACG Capsules

Group Company

ACG Capsules

Primary Responsibilities

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 
 

Key Result Areas

• Effective Technology transfer from R&D with required documentation to manufacturing QA
• Document control for Shade Development documentation.
• Regulatory compliance – Review and escalation

Key Interfaces

Competencies