Job Title
A Senior Production Manager is required to oversee and manage production activities within a facility.
This includes ensuring compliance with cGMP, regulatory authorities, optimization of production processes, leading teams, and ensuring timely delivery of high-quality products.
Key Responsibilities:
* Lead 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.
* Promote a culture of safety and ensure compliance with Environmental, Health, and Safety standards.
Requirements:
* Minimum of a Degree (or equivalent) in engineering, science or manufacturing related discipline.
* Minimum of 5 years' experience managing teams within a manufacturing environment.
* Experience in Sterile and Aseptic fill/finish would be advantageous.
* Good decision making skills.
* Leadership skills and ability to develop or train team members.