:

A. Organization Context

Position

Title: Plant Quality Head

Employee

Name: Grade

Department: Location

Reports to: Unit Head Reported by:

Mgr. Quality

Chemists

(Physical/Chemical/Microbiologist)

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

- 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 current 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;
- Customers
- External agencies/vendors

📌 Manager - Quality Assurance (Bharuch)
🏢 SDP HR Solution
📍 Bharuch