- Develop and ensure Quality Management systems as per regulatory guidelines and quality standards within plant in order to ensure customer satisfaction and business sustainability.
- Develop and sustain Quality culture across the plant
- Review product quality and implement robust CAPA for system and product Quality improvement.
- Establish review mechanism to constantly upgrade and standardize the process.
- Ensure Proper Testing
- Co-ordinate with Production on failures/Root cause Analysis
C. Primary responsibilities
Strategic and planning
Functional
Core
- Review of customer quality complaints (includes complaint investigation, root cause analysis and identifying the CAPA).
- Ensure closure of complaint in defined timelines with implementation of CAPA.
- Review the implementation of CAPA for any non-compliances to maintain the upkeep of the plant as per regulatory norms.
- Ensure sustainability of QMS (Deviations, Change control, OOS and Incident reporting) with QRM
- Ensure timely batch release
- Ensure regulatory compliance, availability of valid Licences and certificates at the plant
- Ensure availability of customer specific certifications for the plant
ACG Associated Capsules
- Handle customer audit independently at the plant and provide support for the team in facing the audit.
- Provide support to the New Product development with QMS & QRM
- Manage escalations from Plant QA/RA and QC areas and take it to conclusion.
- Responding on Time to relevant stakeholders
- Identify various Cost Optimization opportunities within the department and provide direction to the team on various Cost Optimization measures.
- Periodic customer visits jointly with the Plant Head for developing customer relations and gathering customer feedback
Internal process
- Plant Quality monthly reports generation and circulation.
- Review Quality data metrics jointly with the Plant Head, GQA and Global Plant
QA QC Head and identify action plan for the same at the plant on a quarterly basis
- Review of APQR (Annual Product Quality Report)
- Ensure closure of internal and external customer audit points.
- Provide support to internal functions
- Support recent vendor development process by RM/PM testing and evaluation.
People development
- Provide opportunities for people for multitasking and building competent resources.
- Develop second line.
D. Key Result Areas
- Reduction of customer complaints
- Improve Complaint resolution score in survey.
- Reduction of internal failures (Joint responsibility with the Plant Head)
- Timely completion of facility licenses and certifications.
- Timely and effective CAPA replication for customer/internal Audits /APQR