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- Generation of commercial and clinical packaging master batch records for new commercial product launch and repeat commercial projects.
- Generation of clinical packaging master batch records
- Maintenance, review, and update of existing master packaging batch records
- To support the site schedule and readiness to execute
- Generation of Bill of Materials (BOMs)
- General ResponsibilitiesTo comply with company policies including internal and external Health and Safety and Environmental standards as required.To work in a safe manner with due regard to one's own safety and that of others. At all times abide with the companies' health and safety policies.Generation, control, and review of master packaging batch records in line with the site schedule (MPS & Finite).To attend relevant internal meetings as and when required.To ensure compliance with company policies and procedures and internal and external Health & Safety and environment standards.To undertake such tasks and to manage specific internal or ad hoc projects and when required to meet department and business needs and within scope of the jobholders' capabilities and responsibilities.Any further documentation requirements as and when identified to support business and future growth.
- Training Level Specific ResponsibilitiesTechnician Level 1Generation of BOM'sUpdate MBR's with simple to minor updates (Format update, Artwork update, minor change to process step) under supervisionReview simple to minor updates on MBR's (Format update, Artwork update, minor change to process step) under supervision.Create MBR info cards within PCI QMS system.Generate simple to minor MBR's for, Blistering, primary packaging & secondary packaging under supervision.Attend project awareness meetings.Ensure RTE is met every week.Ensure No MOC Actions are overdue.Deputies SQDC meetings when required.
- The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.
- GMP Skill Level 1 is essential for this role
(further information regarding GMP Requirements Hierarchy, can be obtained at SOP-L&D-001)
Product Set Up Specialist - Tredegar, United Kingdom - PCI Pharma Services
Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Main purpose of role:
Provide packaging master batch record service for PCI Pharma in line with business needs, this includes:
Main responsibilities:
Regulatory/Industry Responsibilities:
General
GMP Requirements Hierarchy
Join us and be part of building the bridge between life changing therapies and patients.