Senior Executive, Commercial Quality - Mumbai

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Mumbai, India

Job Description:

Overall purpose of job:

Responsible for the Quality Management System (QMS) establishment, maintenance & implementation at Johnson and Johnson Innovative Medicine (J&J IM) India and Pharm-dedicated 3PL Distribution Centers according to established Quality Manual to provide consistency in managing activities performed at multiple sites to meet customer expectations, applicable regulatory requirements, and Johnson & Johnson policies and standards

Key responsibilities:

1.

GxP Compliance at 3PL Distribution Centers:


* Follow adequate and appropriate quality management systems in collaboration with Deliver, where applicable, and followed at the 3PL Distribution Centers.


* Ensure compliance to requirements for temperature sensitive products (Cold-Chain and cool chain products)


* Support compliance related to J&J IM products handled by standalone/cross sector 3PL Distribution Centers in co-ordination with cross sector owning segment Commercial Quality (e.g., Product Returns, Field Actions, Market complaints, temperature excursions etc.)


* Support during HA inspections at Pharm DC’s and reporting in Curve.


* Provide support for investigations of the Quality Issues and monitor CAPA actions


* Provide trainings on J&J IM India SOPs to DCs on need basis


* Support Management of controlled substances


* Escalate issues observed during handling of controlled substances


* Responsible for providing quality oversights for facilities, utilities qualification and validation activities for CFAs and DCs


* Support for preparing validation master plan and executing the same

2.

Change Management:


* Ensure that all changes related to J&J products and critical changes at External Manufacturing Sites, 3PL warehouses and within J&J IM India are managed through change control system.

The changes are assessed for its impact, executed & closed in compliance the regulatory & corporate requirements


* Ensure appropriate internal and external change control systems are in place and are followed


* Support execution of Change Control Review Board

3.

Local Procedure Management:


* Prepare and update applicable LOC procedures in accordance with local GMP/GDP, BQM and J&J requirements through Tru Vault Document Management sys...