Openings in Hetero for DQA - Microbiology and Openings for Extractable leachable expert in Amneal

Openings in Hetero for DQA - Microbiology and Openings for Extractable leachable expert in Amneal

        Hetero Jobs and Amneal jobs

About the Company 

The company established in 1993, and is of Indian origin, recently completed 25 years of expertise. This is equipped with 36 state of art facilities for manufacturing distributed globally and approved by many regulatory authorities like USFDA, TGA,MHRA, MCC and so on. Company has a profile, as on of the largest producer of anti retroviral drugs for the treatment of HIV/AIDS. Research and development department is given as strong pillar. 
Coming to the portfolio there are about 300 plus products including HIV/AIDS, oncology, immunology, nephrology, cardio vascular, diabetics, urology and so on, these produce a revenue of over 2 billion $ by supplying to around 126 countries worldwide. The firm has centers distributed in Europe, USA and in Argentina there by continuously striving for the progress of the mankind and aiding in providing affordable medicines.
When comes to the API (Active pharmaceutical ingredient), this is one of the largest producer in the world, have large scale production capability with a portfolio of more than 300 API. Visakhapatnam located in andhrapradesh,API plant is one of the  Asia’s largest SEZ complex, having around 500 acers of excellence area. 
This has made a step in oncology portfolio (having 35 plus drugs) and providing medicines at economical prices. Furen Hetero, recently started in China, which is a joint venture between hetero and Furen group in oncology group.
Research and development started division started in 1995, giving opportunity to more than 1000+ scientists, ultimately providing the niche generics, NDDS (Novel drug delivery system), Complex API. Hetero research foundation is a state of art facility with diverse specializations. The group also having biological facility along with its manufacturing and API operations.


Dear All ,

Greetings from Hetero Laboratories Ltd

We have openings for the following

Department : DQA -Microbial

Position: Deputy Manager 

Experience: 10 to 15 yrs.

Work Location: Jadcherla ,Telangana.

Qualification: Any Graduate

Interested candidates kindly share your CV's to [email protected]


Amneal have opportunity for Extractable & Leachable expert at Ahmedabad location. Request to find below the required details:


Required Experience: 12-18 Years

Mandatory Requirement: Must have expertise over Extractable & Leachable studies.

Job Location: Ahmedabad


Job Description:

Review of Extractable and Leachable Protocols/Report for all ANDA submission for multiple dosage forms and provide/discuss comments with cross functional team.

Review of Sterility Assurance Package documents with respect to compliance to regulatory guidelines and submission requirements for Terminally sterilized and aseptically manufactured products Injectable and Complex Products.

Work with R&D and Analytical team and if needed with outside contract facility to finalize the extractable/leachable report as per FDAs expectation for various dosage forms.

Draft the deficiency responses related to Extractable/Leachable queries from Agency.

Provides approaches to conducting safety evaluation of extractables and leachable.

Update the knowledge and current thinking of FDA to avoid any deficiency from Agency.

Prepare regulatory strategies for all relevant projects covering all key points and include in white paper.

Ensure timely availability of final extractable/leachable report for all ANDA submission.

Work very closely with RA Project managers at the time of product initiations & ANDA submission and ensure the availability of quality extractable/leachable report.

Interested candidates may share their CV at [email protected] mentioning the Subject line "Application for Extractable & Leachable Expert