Accomplished Senior Branch Manager at Bajaj Capital Insurance Broking Pvt.ltd, I leveraged expert risk management and exceptional relationship-building skills to enhance branch productivity and staff development. Achieved significant revenue growth by innovating customer service strategies and fostering a culture of excellence. Proven track record in sales management and operations optimization.
Client : Amgen Singapore Manufacturing Pte Ltd (ASM)
Amgen is a American multinational Biopharmaceutical company with independent Biotechnological firm. A global service leader in biologics manufacturing, it has outstanding track record of reliably delivering high-quality medicines to the patients with the serious illnessesses (Osteoporosis, Rheumatoid Arthritis, Bone cancer and kidney diseases.,etc)
Role & Responsibilities:
Perform routine / non-routine sampling and testing of water system, environmental monitoring.
• Performance Qualification (PQ) of utilities (WFI, WDI, and Clean Steam) for manufacturing facility.
• Familiarity on Operation and Maintenance of generation, storage and distribution of Water for injection.
• Perform chemical and microbiological testing (Bioburden, Endotoxin and Visual appearance) for water samples.
• Perform all required data entries into LIMS (Laboratory Information Management System) and cGMP documents.
• Maintain and update the quality management system (QMS) including reporting and follow up on corrective and preventive actions arising from audits and non-conformance
• Awareness of programming of Delta V automation system.
Analysis of Chemical and Microbiological tests:
• Perform routine microbial/chemistry sampling and testing by using established protocols to support the manufacturing processes/process validation.
• Execute manufacturing activities by providing QC support to the in-process testing of production samples.
• Experienced in co-ordination between various departments (QC, QA and Manufacturing) with regards to QC Testing and reporting of results.
• Conducting the Total Organic Carbon (TOC) analysis, Total aerobic count (TAC endotoxin, bio burden, nitrate, and conductivity, Coliform testing of Purified Water, WFI, and Clean Steam.
• Perform quality testing of raw materials, in-process and finished products.
• Maintain thorough understanding of GMP and GLP regulations and have applied this knowledge to ensure proper documentation to support testing procedure.
• Document and review executed procedures and record data in compliance to quality system specifications.
• Perform calibration / verification and maintenance for all laboratory equipment.
PQ of Environmental Monitoring of Clean room areas
• Evaluate cleaning effectiveness of manufacturing suite to meet ongoing quality processes and compliance.
• Well trained in gowning procedures according to ISO Grade 5, 8 and ISO 9 clean room facilities.
• Perform Viable and Non-Viable environmental routine and non-routine monitoring, sampling and testing of clean room areas and biological safety hood by performing CFU calculations from viable air sample plates, contact plates.
• Support the route cause analysis for sample failure and Out of Specifications by Initiating discrepancy report for environmental monitoring action excrutions, adverse trends and deviations.
Handling Equipments for EM:
Practiced environmental monitoring by using MET One 3400 portable air counter, CLiMET® 1054 is laser particle counter for air particulate monitoring and Viable monitoring by using Emtek P100 Air Sampler, SAS Super 100 Sampler, Mas 100 Air Sampler.
Areas expertise:
§ QC testing and Sample Management
§ Microbiology lab operations
§ Routine and non- routine Environmental Monitoring of classified manufacturing clean rooms
§ Biochemistry and Molecular biology techniques
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