Empleos en Maçanet de la selva, cataluña, españa

Job Title : Deputy Manufacturing Manager

About the Job :

The Deputy Manufacturing Manager is responsible for overseeing and managing aseptic manufacturing operations within a cleanroom environment. This role ensures compliance with cGMP regulations, leads process improvements, and provides strong leadership to a team of supervisors and operators. The Deputy Manufacturing Manager will directly oversee 4 to 6 direct reports and support a manufacturing division of approximately 120 personnel involved in the production of mammalian or microbial-based pharmaceutical or biologic products.

Key Responsibilities :

• Oversee and manage all aspects of aseptic manufacturing, including sterile filling, lyophilization (if applicable), capping, and inspection processes.
• Ensure strict adherence to aseptic techniques, environmental monitoring, and gowning requirements to maintain sterility assurance.
• Provide leadership and guidance to a team of 4 to 6 direct reports, fostering professional growth and ensuring alignment with operational goals.
• Support and oversee a broader manufacturing division of approximately 120 personnel, ensuring operational efficiency and compliance.
• Collaborate with maintenance, engineering, and quality teams to troubleshoot equipment issues and ensure minimal downtime.
• Drive continuous process improvements, optimizing manufacturing efficiencies while maintaining compliance with FDA, EMA, cGMP, and other regulatory requirements.
• Participate in regulatory audits and inspections, ensuring documentation accuracy and process validation compliance.
• Maintain and approve manufacturing documentation, including SOPs, batch records, deviations, CAPAs, and change controls.
• Lead investigations into process deviations and implement corrective and preventive actions (CAPAs) to ensure ongoing compliance and operational excellence.
• Foster a culture of safety, compliance, and continuous improvement across the manufacturing team.

Requirements :

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