About the Company
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