Overview: This position will report to the Manager Manufacturing.
The ideal candidate will provide strong leadership to the Manufacturing teams on a 24/7 shift pattern in a sterile Drug Product facility.
They will have strong GMP and quality system knowledge and the ability coach/mentor a team on the quality system requirements as well as maintaining a strong culture of safety within their shift team and in the manufacturing area in general.
The candidate will have excellent troubleshooting skills using standard industry problem solving techniques.
Job Summary: Support the Manufacturing Manager in leading a shift of Process Technicians to achieve production targets efficiently in line with GMP, safety and other regulatory standards in an assigned process area.
Ensure shift Process Technicians are given clear direction and information to perform daily tasks as per the production schedule.
Lead an assigned process area Work Centre Team (WCT) to ensure cross functional alignment on objectives and action plans.
Ensure the manufacturing schedule is accurate and up to date reflecting current status of production and clearly plan out all critical path activities for assigned process area.
Foster a good safety culture in our team and act as a safety role model Be responsible for compiling, maintaining, and reviewing all necessary reports, documentation batch records/ EBRs relevant to the manufacturing area including use of relevant software systems and standard operating procedures.
Proactively identify training needs for their manufacturing shift and facilitate completion of training to meet the area resource and cross training models.
Assist, plan and implement continuous improvement ideas / opportunities using lean principles.
Be proactive in the identification of process related issues including escalation & follow up for effective resolution to minimise impact on the manufacturing schedule.
Contribute and assist with corporate, FDA, HPRA and other regulatory bodies during company audits.
Takes the lead on the 24/7 shift team in the absence of the Manufacturing Manager Basic Requirements: Educated to degree level or equivalent in a scientific or engineering discipline Must have relevant aseptic experience within a manufacturing function in a sterile pharmaceutical manufacturing or similar environment Be results-oriented with excellent organizational, communicational and team development skills with an ability to successfully interact with people, create a team environment and generate co-operation.
Strong understanding of the quality system requirements and regulations for working in an aseptic drug product facility and ability to communicate those requirements to the manufacturing team.
Demonstrated ability to deliver to team, site and personal objectives.
Preferred: Demonstrated understanding and use of right first time techniques and lean manufacturing concepts.
Team leadership experience leading a process area in the manufacture of sterile drug Strong ability to lead, challenge and positively influence in an interactive team environment Strong computer skills - knowledge of Electronic Batch Records (PAS/X), Quality tracking system (QMTS) and personnel performance tracking (MAP) etc.
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