About Company:
Hetero is one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs. Backed by 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, generics, biosimilars, custom pharmaceutical services and branded generics. The company is globally recognized for its strengths in Research and Development, manufacturing and commercialization of a wide range of products. Hetero has 36 state-of-the-art manufacturing facilities strategically located worldwide, approved by stringent global regulatory authorities. Our portfolio includes 300 plus products encompassing major therapeutic categories such as HIV/AIDS, Oncology, Cardiovascular, Neurology, Hepatitis, Nephrology, Urology, Diabetes, Ophthalmology, Hepatology and Immunology etc. Hetero has a strong global presence in over 145+ countries and focusses on making affordable medicines accessible to patients worldwide.
Website
http://www.hetero.com
Job Description:
Injectable & Medical Devices :
1. Define strategy for Drug Device Combination Products (DDCP) and align across functions such as Business Development, Intellectual Property (IP), Portfolio, Sales & Marketing, Formulation, Quality, Regulatory, & Manufacturing
2.Develop & execute end-to-end Packaging Solutions across all formats including Auto Injectors, PEN Injectors, Prefilled Syringes, Vials, Ampoules, Cartridges etc., in partnerships with Design Houses, Prototype Suppliers, and Manufacturers (of Devices, Cartridges, PFS, Vials, Ampoules, Rubber/Plunger Stoppers etc.)
3. Co-Develop, validate, & implement various Primary Packaging Lines, Device Assembly Lines, Secondary & Tertiary Packaging Lines in partnerships with Engineering Team and Equipment Suppliers. Achieve Material-Machine Interfaces, with maximum efficiency & productivity
4. Develop, validate, & implement various Packaging Analytical & Laboratory Testing Equipment and Operating Methods
5.Execute Development Batches, Exhibit/Submission Batches
6. Responsible for generating Device Functionality Tests and for preparing Regulatory Submission Packages (Device History File or DHF) for combination products. Fully implement Regulatory Guidelines such as ISO 11608, ISO 13485, ISO 14971, FMEAs, Risk Management/Control, Human Factor Equivalency Studies, and Response to queries from Drug Authorities
Vacancy Details :
Medical Device :
Packing Development
Job Location :
Jeedimetla, Hyderabad
Contact :
vijaybabu.r@hetero.com