- Support Manufacturing Manager and Manufacturing TLs by management GMP documentation within the manufacturing areas, as the finite schedule SME in manufacturing and building and reporting manufacturing KPIs.
- Coordinates the management and tracking of GMP documentation and quality actions within the Manufacturing areas including:
o Manufacturing Batch records
o Quality Actions (deviations, CAPA, change controls)
o Develops KPIs for documentation completion versus schedule and activity RFT criteria
- Measure and report RFT / trend data and work with departments to resolve recurring issues
- Maintains the weekly finite schedule (from Supply Chain) and measures daily adherence and updates Supply Chain on batch completion details
- Updates tier 0 and tier 1 metrics daily, as required, on behalf of manufacturing TLs and/or manager
- Coordinates preparation of manufacturing presentations for routine forums such as Quality review, S&OP, etc.
- Attends weekly schedule meeting in lieu of Manufacturing managers for TLs if required
- Leads preparation activity in manufacturing for internal and external regulatory audits
- Participate in internal supplier and regulatory audits and key quality initiatives as appropriate
- Liaise, schedule and support Process Engineering and Facilities works to be carried out and raise work orders and GMP permits as required.
Education & Qualifications Required:
- Third level qualification an advantage
- Minimum of 2 years’ experience in a similar role
- Experience working in a GMP environment is required
- Excellent organisational skills
- Excellent accuracy and attention to detail
- Excellent interpersonal skills
- Working knowledge of computer packages
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.