B. Job Objective
• 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
Job Description
• Handle customer audit independently at the plant and provide support for the
team in facing the audit.
• Provide support to the Recent 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 new 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
E. Key Interfaces
Internal Interfaces External Interfaces
• Operations
• NPD
• Technical Services
• Scitech Centre
• Q&RA;