Our client, a pharmaceutical company in Mayo are currently looking to recruit a Biologics Inspection and Packaging Senior Manager for their site.
Senior Manager of Inspection and Packaging to support Biologics Capacity Expansion. Work closely with a cross functional team including but not limited to Global Pharm Tech, Engineering, Quality, Validations, QCI and external Design Team to develop and qualify commercial inspection and packaging areas to support the Business needs. Initially the role will be heavily involved in the development and qualification of Biologics vial and prefilled syringe inspection and packaging processes to ensure the facilities are commercial ready from a Personnel, Quality, Safety and Opex perspectives.
Hire will lead a team of personnel to develop and commercialize Biologics Capacity Expansion projects.
- Recruitment and development of Biologics Capacity Expansion Inspection and Packaging Department.
- Develop themselves and their teams as SME on biologics product components, primary container closure, container closure integrity, equipment, automation, data integrity, QRM (CQA’s, CPP’s, CCP’s), cross contamination, coding labelling, thermoform sealing, cartooning, T&T
- Knowledge on all upstream & downstream processes and impact of subprocess to CQAs, industry complaints, customer, etc…
- High level of input into DFMEA & PFMEAs for facility, equipment and process
- Challenge of Design documentation to meet QA, OPEX and EHS requirements (URS, ES, DS, SDS, HDS, FSDS, RTM, DQ, Pre-FAT, FAT, SAT). Vendor site visits.
- Review, approval & execution of validation activity to meet QA, OPEX and EHS requirements (IQ/OQ/PQ/PPQ)
- Work in conjunction with BCE Trainer on the development of overarching training strategy and roadmap for BCE Operations (Inspection and Packaging)
- Develop and execute clear action plans to ensure Inspection and Packaging Department is ready for commercial launch per EHS, QA and Opex requirements.
- Development of process flows, SOPs, risk assessments, training processes, batch records, logbooks and necessary documentation to support a commercial Inspection and Packaging department.
Education & Experience
- Bachelor’s degree in Science/Engineering or equivalent.
- Minimum 7 years’ experience in the Pharmaceutical/Biopharmaceutical industry
- Knowledge/Experience of working within an Inspection/Packaging environment
- Proven track record in effective people management to deliver on business goals and objectives
- Good interpersonal and communication skills essential for working across multi-functional teams
For further information on this Biologics Inspection and Packaging Senior Manager role in Mayo please contact Clara Burke on 086 8168273 / firstname.lastname@example.org
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