MSAT PD Lab - Assistant / Executive

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)