Production Supervisor

OVERALL ROLE OBJECTIVE: The post holder will be expected to supervise a team of personnel within the Production area in order to ensure that product is produced in accordance with the relevant SOPs. The post holder will be required to promote continuous improvement whilst ensuring there is adherence to cGMP, Almac SOPs and Policies.

JOB SPECIFIC RESPONSIBILITIES: The post holder will: 1. Monitor, on a daily basis, the allocation of tasks to relevant production personnel in line with business needs and customer expectations, arranging overtime as required and managing leave to ensure departmental KPIs are met. These tasks include, for example:

• Issue and reconciliation of material
• Production set up checks
• Review of executed batch records
• Monitoring output and efficiencies
• Ensuring reject rates are kept to a minimum
• Ensure production analysis details are completed promptly and accurately as soon as possible after completion of operation
• Assist in the delivery of factory tours for customer visits or audits

2. Maintain a regular presence on the floor to ensure supervisory oversight in order to monitor compliance with cGMP and general housekeeping within the Production areas. 3. Review resources within the team and ensure sufficient, trained personnel are available to perform the tasks. In doing so, become involved in the recruitment and selection process. 4. Review and approve GMP documentation as detailed in the relevant procedures. 5. Foster a positive environment within the team to promote staff development and facilitate team meetings. 6. Perform the role of key-trainer and mentor personnel in the team providing advice and guidance in order to build on their competence and experience. 7. Monitor output, quality and consistency of reporting staff and provide feedback regularly throughout the year and via the PMP process. Recognise good performance and address poor-performance and any issues in accordance with HR policies. 8. Be accountable for staff performance, ensuring departmental Key Performance Indicators (KPIs) are met. 9. Act as a Production representative on assigned business projects, providing advice and guidance from a Production perspective, ensuring a positive approach to continuous improvement. 10. Continuously consider opportunities for business improvement and be forthcoming with ideas/suggestions regarding process simplification and improved compliance. Be proactive regarding implementation of such through the generation/revision of SOPs and ensure good engagement with global counterparts in order to gain agreement (as required). 11. Report / escalate serious / potentially serious breaches of GMP compliance or matters of concern to the Production Manager in an open and timely manner for appropriate resolution. 12. Provide support to the Lead Investigators during the conduct of an investigation to enable them to perform a thorough root cause analysis. 13. Ensure any CAPA / Follow-up items assigned to you or your direct reports are actioned in a timely manner or that an Addendum is submitted if it is not possible to complete in line with the target completion date. 14. Apply problem-solving skills to a wide range of issues and act in a Production advisory capacity. In doing so interact with relevant Project Services and Quality personnel in order to address quality issues. 15. Attend teleconferences / meetings / customer visits, as required, representing the Production department. 16. Provide data as required for customer meetings in relation to Production activities. 17. Work to a consistently high standard, even when under pressure. 18. Maximise efficiency through successful time management and the ability to prioritise daily activities independently. 19. Fulfil any necessary administrative duties associated with the role, as and when required. QUALIFICATIONS

Degree (or equivalent) or significant relevant supervisory experience KEY SKILLS

Proven ability to complete documentation of an exceptional standard Ability to adhere to written instructions High attention to detail

Ability to work effectively on own initiative and effectively contribute within a team environment Effective communication skills (verbal, written and interpersonal)