Our client, a pharmaceutical company in Mayo are currently looking to recruit an Inspection & Packaging Manager for their site.
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.
Packaging Manager Role required to support New Product Introductions in Packaging for various technologies. The Packaging Manager role will be the primary point of contact for on the selected projects and will coordinate activities to ensure all deliverables are in place to facilitate a smooth transition to commercial operations. This role will work with various functions to facilitate a smooth transfer from R&D/ GPT to operations for given projects. The Packaging Manager will be responsible for ensuring all GMP activities are assigned to various functions and that timelines are adhered to.
- Recruitment and development of Biologics 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
- MSc degree with three years’ experience or a degree in a Science or Engineering discipline with five
- or more years of applied experience in Pharma/ Biologics.
- Experience with commercial & / or clinical manufacture.
- Excellent technical writing and communication skills.
- Proven ability to problem solve.
- Must be a self-starter with a pro-active approach
- Experience with interacting in project teams.
- Experience with packaging technologies
- Flexibility of working hours may be required
- Experience with GMP regulatory inspections
For further information on this Inspection & Packaging Manager role in Mayo please contact Clara Burke on 086 8168273 / firstname.lastname@example.org
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