Specialist - Quality Manager/Associate - THV Return Inspection - Medical/Pharmaceutical

Role Purpose:

The Quality Associate will be responsible for the inspection of return product at Mumbai warehouse and support to QMS implementation within India Organization and India 3PL sites. This person will also be supporting in oversight in supply chain activities, implementation of Internal audit procedure and providing inputs in India management review process.

Job Functions:

Being Quality Representative, this person will ensure that THV return inspection is done as per company Procedures at warehouse. Also this person will have a supporting role in establishment of Quality Management System (QMS) in country office and 3PL sites in compliance with ISO13485, 21 CFR 820, The Drugs and Cosmetics Act in India, the relevant regulatory requirements in India and all other applicable requirements.

Required Education/Skills/Experience:

Education: Bachelors degree or related degree in a scientific field required preferably in medical expertise and Quality Management. An advanced degree (i.e. Master, PhD) is a plus. Good Management / Leadership / Risk Management, Analytical and Communication skills essential. Solid understanding of Quality Systems, National regulatory requirements PC skills required

Languages: Languages of India (Hindi) and English essential, any additional language is a plus

Experience:

- Minimum of 5 years professional experience in Quality Management in a medical or pharmaceutical Quality environment. Experience of working with US companies/exposure to US environment. Preferably with some experience in warehouse management.

- Knowledge in process validation and risk management

- Adequate knowledge in ISO 13485, 21 CFR 820, 21 CFR 11, Drug & Cosmetic Acts the relevant regulatory requirements in country, and all other applicable requirements.

- Experience of Regulatory Inspection/ Local Inspection preferred.