post graduation in Biotechnology/ biochemistry/ Microbiology/Chemistry: QA-Manager(Biologics)

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Dear , Position - Manager – Quality Assurance - Biologics Exeperience – 6 - 8 Years Qualification – Post graduation in Biotechnology/ biochemistry/ Microbiology/Chemistry. Job Description : •Should have experience in managing the quality function of commercial manufacturing unit catering to India and semi-regulated markets. •Should be team leader as well as team player with sound analytical, communication and interpersonal skills. •Should be able to review the QC reports and guide QC function for GMP compliance. •Should have competencies required for understanding and analyzing the microbiology, immunology and bioassay analysis reports. •Experience in handling Internal audits, CAPA, deviations, change controls, OOS, OOT, investigations related to process and product failures, market complaints etc. •Experience in handling technology transfers and analytical method transfers from R&D to plant. •Should have hands on experience in conducting qualifications of manufacturing and services equipment (DQ/IQ/OQ/PQ). •Should have experience in validating HVAC, Purified water, WFI, Pure steam, Process gases etc. •Should be well versed with process validations and analytical method validations. •Minimum One to two years experience in the managerial function of manufacturing plant. Desirable : Must have experience of at least five years in the QA departments of reputed biological industries working on recombinant therapeutic proteins . Knowledeg of: 1. Biosimilars / guidelines - process knowledge, execution of validations 2. Analytical method qualifications / validations. 3. Biotech Process(Media prep-upstream-Downstream process), clean utilities . 4. Bioreactor validations, water system validations. 5. Manufacturing and maintenance. Regards: Ranjana-080-41663048 Email id-ranjana@yuchra.com

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