Executive To Assistant Manager -Plasma Fractionation

Role & responsibilities

• Execute and monitor plasma fractionation and downstream processing activities including plasma thawing, fractionation, precipitation, centrifugation, filtration and purification.
• Support manufacturing and quality activities for Albumin, IVIG, Immunoglobulins, and other plasma-derived products.
• Operate and monitor process and laboratory equipment as per approved SOPs, BMRs and specifications.
• Perform sampling and testing of plasma, raw materials, intermediates, bulk and finished products as applicable.
• Support analytical, biochemical and microbiological testing including protein concentration, purity, pH, osmolality, electrophoresis, potency, bioburden, sterility and endotoxin testing.
• Review manufacturing and analytical records to ensure compliance with approved procedures and specifications.
• Perform and support line clearance, batch record review and shop-floor QA activities.
• Handle and participate in investigations related to deviations, OOS, OOT, incidents, CAPA and change controls.
• Ensure compliance with GMP, GLP, data integrity, biosafety and applicable regulatory requirements.
• Support process validation, cleaning validation, method validation/verification/transfer and equipment qualification activities.
• Maintain accurate and complete manufacturing, QC and QA documentation.
• Coordinate with Production, QA, QC, Engineering, Warehouse and other cross-functional teams for smooth batch execution and timely release.
• Participate in internal audits, regulatory inspections and compliance activities.
• Monitor process performance, yields and quality attributes and report abnormalities to the concerned department.
• Follow all applicable safety, hygiene, contamination-control and controlled-area requirements.

Preferred candidate profile

Candidates with hands-on experience in plasma fractionation, plasma-derived medicinal products, Albumin, IVIG, Immunoglobulins, coagulation factors or plasma protein purification will be preferred.

Experience in GMP-regulated biologics, blood products, biotechnology or sterile pharmaceutical manufacturing may also be considered.