A Senior Production Manager is required by CareerWise Recruitment for our Galway based client. The Senior Production Manager will be responsible for overseeing and managing production activities within the Galway facility. This includes ensuring compliance with cGMP, regulatory authorities, optimization of production processes, leading teams, and ensuring timely delivery of high-quality sterile injectable products. This role requires someone who has worked in Sterile Environment.
Role of this position
* Lead and supervise daily sterile filling operations, ensuring compliance with manufacturing schedules and quality standards.
* Manage and develop a team of Production Supervisors, fostering a high-performance culture.
* Review, approve, and distribute manufacturing instructions for APIs and intermediate solutions.
* Oversee the production and filling of products into vials or syringes according to approved procedures.
* Ensure compliance with cGMP, FDA, HPRA, and other regulatory bodies; support audits and inspections.
* Maintain a trained workforce and implement ongoing retraining programs to meet evolving regulatory requirements.
* Collaborate with Engineering, Technical Services, QA, QC, Supply Chain, and R&D to support operations, equipment maintenance, and validation activities.
* Manage department budgets, monitor consumable inventory levels, and ensure the upkeep of production facilities.
* Review and approve documentation including batch records, deviations, CAPAs, change controls, and SOPs.
* Promote a culture of safety and ensure compliance with Environmental, Health, and Safety standards.
JOB REQUIREMENTS
* Minimum of a Degree (or equivalent) in engineering, science or manufacturing related discipline and a minimum of 5 years’ experience managing teams within a manufacturing environment (preferably pharmaceutical).
* Experience in Sterile and Aseptic fill/finish would be advantageous
* Good decision making skill
* Capability to set clear goals, communicate these clearly and ensure progress to completion
* Leadership skills and ability to develop or train team members.
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