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
Internal Interfaces
External Interfaces
- Purchase
- Production
- Sales & Marketing
- NPO
- Vendors
- Customers
Competencies
QMS
QMS Software Proficiency
Knowledge of Regulatory Guidelines for Food
Technology Transfer & Third Party Management
Technical Agreement
Persona-Builder
Persona-Innovator
Persona-Nurturer
Persona-Partner
Has the candidate displayed any of the Values (Caring/Collaborative/Progressive) during the discussions
