Promoted by the late Mr. Amrut Mody, a pioneer of the Indian pharmaceuticals business, Unichem Laboratories has grown to become one of India’s most respected pharmaceutical companies. It is committed to delivering better health through superior products. By combining strategic research and in-depth industry knowledge, Unichem aims to transform itself into a global pharmaceutical drug company with an increasing focus on cutting-edge research and developed markets.

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With formulations constituting the core of the company business, Unichem is backward integrated to API Manufacturing, which adds value to the customer in terms of quality and sustainability.

Position: Officer- Manager CQA

Location: Hyderabad

Job Description:

1. To ensure that the manufacturing and testing of Unichem Intermediates and APIs at the Optimus Drugs and Optrix Laboratories are as per the Unichem approved and filed manufacturing process and testing procedures ensuring cGMP and CGLP compliance.
2. To review Change controls and all associated documents including Risk Assessment raised and approved by Optimus Drugs/Optrix Laboratories and sent to Unichem CQA for customer approval.
3. To review and track the progress of validations of Unichem intermediates and API being executed at Optimus Drugs and Optrix Laboratories ensuring the execution as per the approved protocol.

4. To provide the customer approval for all related manufacturing documents to Optimus Drugs/Optrix Laboratories.
5. To review and approve Vendor qualification documents for additional raw material vendors other than Key intermediates as and when required by Optimus Drugs and Optrix Laboratories in consultation with PR, RA, and Head CQA.
6. To perform internal audits at Unichem manufacturing locations and audit other vendor sites as and when required. To ensure that audit reports and compliance reports with CAPA plan are prepared and implemented.
7. To ensure for all Unichem products being executed at Optimus Drugs/Optrix Laboratories locations that detailed investigations are in place for Out of specifications, market complaints, Unplanned deviations, OOT, stability failures, and that appropriate CAPA is planned and executed as per the defined procedures.

The Employee will be on Unichem Laboratories Limited Company payroll but will be based out at Optimus Drugs and Optrix Laboratories at Hyderabad

Qualification: M.Sc

Experience: 10-12 Years

Salary: Negotiable

Contact Details:

hrd@unichemlabs.com

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