MSAT PD Lab - Assistant / Executive

5 - 10 years

3 - 8 Lacs

Posted:4 months ago| Platform: Naukri logo

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Full Time

Job Description

Job Title: MSAT (PD Lab) Assistant / Executive

Location: Kakinada, AP

Company: Lyfius Pharma
About Lyfius Pharma is 100% subsidiary of Aurobindo Pharma. Its largest API Unit of Aurobindo. Lyfius spread across 236 acres in Kakinada SEZ and it is second largest API manufacturing facility in ASIA.


Roles & Responsibilities• Responsible for Validation which shall include: Preparation/Review/Approve of MPR. Preparation/Review/Approve of process validation protocols. Preparation/Review/Approve & compilation of validation report.• Responsible for Tech transfer which shall include: Coordination with Vendor/cross functional teams for Tech transfer activities. Execution of Tech transfer products at Receiving Units.• Responsible for QIP which shall include: Identifying root cause for QIP. Execution of QIP. Conclusion/Recommendation of QIP.• Responsible for OOS/OOT investigation which shall include: Identifying probable and most probable root cause for OOS/OOT.• Ensure that validations is carried out as per the protocol & qualification protocols meets the cGMP & regulatory requirements.• Follow up & coordinate with cross functional team for execution of validation.• Give the input for the monthly reporting system, participate in the internal & external audits, present the documents to auditors/inspection team.

Educational qualification: Masters/Bachelors Chemical

Minimum work experience: 5-8 years of experience in Process development / MSAT / Tech transfer

Skills & attributes:

Technical Skills
• Experience in the scale up/ technology transfer of products in relevant dosage forms or technologies. (API)