Job Description
Oversee the quality functions within Morphotek’s biopharmaceutical pilot plant.
Manage and mentor Senior Manager/Manager level functional department heads within the plant ensuring adherence to cGMPs, EMEA, ICH and JP regulations.
Once the plant is operational this individual will provide quality oversight of manufacturing, microbiological processes, sample receipt, validation and training.
Serve as the principle quality assurance resource for the biopharmaceutical manufacturing facility and manage, advise and guide activities of the department staff.
Direct department activities to ensure implementation of quality systems, including, but not limited to, document control system, creation and revision of SOPs, training, deviations, corrective/preventive actions and internal auditing.
Direct department activities to ensure creation, implementation and quality review of production batch records, analytical test results, and environmental monitoring processes.
Create trend reports of processes such as environmental monitoring results, deviations, analytical test investigations, and audit findings. Ensure execution of internal audits.
Interact internally with Operations, Project Management, R&D, Finance and Senior Management.
Review of technical, validation and other protocols and reports, with emphasis on adherence to quality and to FDA, EMEA, ICH and JP guidelines.
Desired Skills & Experience
Graduate level degree in quality and/or biological sciences or related subjects is preferable. Must have knowledge of FDA, EMEA and JP regulations as they pertain to building design, aseptic process requirements and development of antibody-based biotherapeutics
At least 8-10 years experience as quality assurance senior management of which a significant portion must be with oversight of the manufacturing of antibody-based biotherapeutics or biologics
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Email: jobs@aarenconsultants.in
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