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.
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.
- 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.
- To establish customer complaint CAPA sustenance mechanism.
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), analyse OOT in APQR and impart action on the same.
- 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.
Qualifications:
- Bachelor or Master of Engineering or any related fields.
- Background in Food, Pharma, FMCG and Healthcare.
- Training Abroad.
- Good of English.
Qualified candidates, please contact K. Patsakorn 081-104-8993 Mon-Fri
