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An established industry player is seeking a Production Fill & Finish Senior Supervisor to ensure compliance with stringent GMP standards and lead a dedicated team in a fast-paced environment. This role involves overseeing daily operations, managing training programs, and driving continuous improvement initiatives. The ideal candidate will possess hands-on experience with sterile automated filling machines and demonstrate strong leadership skills. Join a forward-thinking company focused on developing innovative biotech products and making significant scientific breakthroughs in the pharmaceutical industry.
Ensure all daily activities related to fill & finish operations are executed smoothly, aligning with GMP/WHO TRS Sterile standards, and resolve any issues promptly.
Coordinate & implement training programs for all fill & finish personnel, evaluate training effectiveness to ensure compliance with regulatory and quality standards such as integrity, aseptic behaviors, safety, & GDP.
Manage daily activities across teams to maximize personnel and equipment utilization across shifts, optimizing efficiency.
Oversee data management tasks, ensure accurate data entry, and troubleshoot ERP system issues as needed.
Ensure all personnel & teams understand safety & GMP protocols, monitor compliance, and lead investigations to resolve any issues.
Coordinate continuous improvement initiatives based on data analysis and process evaluations, collaborating with stakeholders to enhance safety, quality, & efficiency.
Prepare detailed equipment & machine URS and timelines, oversee procurement to ensure machines are ready and qualified within schedule.
PT Etana Biotechnologies Indonesia is an affiliate company investing in building a biosimilar plant, focusing on drug substance (host cell) development and manufacturing locally.
Our portfolio includes a wide range of biosimilars, especially in the field of hormones. We are also involved in developing cutting-edge biotech products and have a track record of major scientific breakthroughs.