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Lead and develop a multidisciplinary team of process engineers, specialists, and manufacturing professionals, fostering a culture of safety, quality, accountability, and continuous improvement. Take ownership of operational performance within the DSP
Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM; Participate in internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs;
Root cause analysis (RCA) and CAPA implementation for project topics, and general lab topic. Investigation and management of deviations, as Lead Investigator. Quality oversight and audit readiness in GMP-regulated labs (participation in audits for
This role will be pivotal in ensuring all products manufactured meet the standards required for marketed drug products. They will be accountable for defining contamination control strategy and its sterility assurance practices and sever as a subject