Strategic and planning
- Support in compliance through various digitalization platform
Functional
Core
- Ensure good documentation practice
- Validation & Qualification of Machine and Equipment's
- Requalification of machine and equipment as per frequency
- Preparation and updating of site master file and validation master plan
- Execution & preparation of process validation / Cleaning validation
- Execution & Preparation of Annual Product Quality review
- Review deviations for RM, finished products and systems
Gals
- Analytical Method development and validation.
- Monitor equivalency test of compendial methods and technology transfer.
- Raw material vendor development
Internal Process
- Preparation and submission of monthly report (QMS related).
- Quarterly review of product parameter (Trend analysis).
- Provide data for monthly quality metrics
People development
Training and group discussion with colleagues to motivate them for organization benefit and individual development.
- Key Result Areas
- %tage compliance on Customer and Regulatory audits
- Qualification & Validation of equipment, process as per timelines
- Adherence of equipment Calibration plan (for entire site)
- Complaint resolution within timelines
- Key Interfaces
Internal Interfaces
External Interfaces
- Operations
- MSAT (TTT)
- Technical Services
- Scitech Centre
- Q&RA
- External Auditor
- Customers
- Stakeholders from different Units/plants
