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1.0 - 6.0 years
2 - 7 Lacs
Visakhapatnam
Work from Office
Role & responsibilities: 1. Should have hands-on experience in manufacturing of plasma derived proteins like IgG, Albumin, clotting factors etc. 2. Hands on experience in nanofiltration of plasma derived proteins. 3. Experience in URS preparation and qualification of equipments in downstream manufacturing facility. 4. Should have experience in handling chromatography systems like AKTA process, AKTA Pilot etc. and execute chromatography operations. 5. Should have experience in handling different columns like BPG column, chromaflow column and Axichrom column including its packing and unpacking. 6. Should have experience in handling continuous centrifuge. 7. Should have experience handling Semi-automatic and manual TFF systems . 8. Execute and monitor supporting activities like steam sterilizer, DHS, Filter integrity machine etc. 9. Should have experience in handling stainless steel vessels, single use bags and CIP/SIP skids . 10. Experience in preparing the solution/buffers for downstream operation. 11. Experience in execution and review of batch manufacturing records, solution preparation records, log books etc. 12. Experience in keeping the facility neat and clean with respect to internal and external audits. Initiation of QMS documents like Change control, Deviation, Risk assessment, CAPA, change implementation and effectiveness verification and support for closing open documents on time. Qualification: M.Sc/M.Tech/B.Tech
Posted 1 day ago
7.0 - 9.0 years
7 - 9 Lacs
Manesar
Work from Office
Role & responsibilities : Knowledge in handling and troubleshooting purification chromatography systems & columns at small scale and large scale Various Chromatography techniques like Ion exchange, Affinity, HIC etc. TFF systems , Hollow Fiber/cassette Should be well versed with FPLC, AKTA- Process, AKTA- Pilot. Capabilities for linear scalability of R&D process to Mfg. scale. Batch planning, Resource management, Team Training. Shift Schedule Preparation, Audit readiness Handling QMS, Project management, Deviation, Change control, CAPA, OOS, GDP Plan daily downstream execution activities Drive the qualification activities for all downstream equipment. Execute, troubleshoot, and scale up of purification processes, aseptic Operation. Compliance to cGMP in all the manufacturing activity, and timely closure of executed documents and batch records. Active trouble shooting to minimize the various risks prior to execution and during execution. Preferred candidate profile: Should have good communication and presentation skills (verbal & written) Person with high self-motivation, go-getter, enthusiastic. Leadership skills, with steadfast resolve and personal integrity Should have minimum 7 + years of Experience.
Posted 4 weeks ago
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