Job Description

ABOUT OUR CLIENT'S COMPANY :
 
It's Multinational Organization dealing in Medical Device.
 
PURPOSE OF POSITION :
 
To manage and develop the Quality Management System for the Company in India ensuring that it is in line with defined and expected quality management system of parent company and this is achieved through close co-ordination with quality director and corporate quality team.
 
MAIN DUTIES / RESPONSIBILITIES:
 
1. Overall responsible for ensuring compliance of defined procedures for QA/QC and GDP compliance.
2. Facilitate the implementation of quality management system and compliance to Kandla unit.
3. Training of colleagues for the function of Quality assurance, quality control and warehouse.
4. Supporting quality corporate team on investigation of customer claim and complaint pertaining to Company's shipment.
5. Co-coordinating for third party services, inspection agencies and facilitate implementation of services from third part service provider
6. Active part of management team for continuous improvement process.
7. Supporting and facilitating all external audits including regulatory and customer audits.
8. Ensuring compliance for local rules and regulations and ensuring valid license from FDA.
9. Knowledge support from technical perspective for Company's Team.
10. Conduct and document internal audits in close co-ordination with corporate quality team.
11. KPI reporting for responsible areas.
12. Prepare, review and approval of SOP for Company.
13. Assist in implementing various projects where quality function is involved and required
14. Review and monitoring of performance of supplier from non-compliance perspective and actively working with QA and procurement team for effective measures.
15. Ensure division of task within department, sufficient resource and screening of candidates for new recruitment
16. Facilitate and ensure quality work culture for colleagues and develop the competencies of colleagues in quality and warehouse.
17. Overall quality oversight on operation in Company and QA presence.
18. Overall quality responsible person for Company as operation.
 
DESIRED PROFILE :
 
- 10+ years experience with at least few years experience in managing a team in pharma
- Experience in large warehouse and packing operations is a must
- Background in LEAN, change management, Statistical quality controls, GS1, barcoding, automation will be highly preferred
- Experience in MNC, structured organization preferred
- Good English Communication Skills
- Experience in Audits
- Knowledge of GMP, GDP, MDR and other guidelines

Skills Required