Job Information
PCI Pharma Services Packaging Documentation Technician Level 1 in Oakdale, United Kingdom
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:
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)
Main responsibilities:
General Responsibilities
To 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 Responsibilities
Technician Level 1
Generation of BOM’s
Update MBR’s with simple to minor updates (Format update, Artwork update, minor change to process step) under supervision
Review 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.
Regulatory/Industry Responsibilities:
General
- The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.
GMP Requirements Hierarchy
- GMP Skill Level 1 is essential for this role(further information regarding GMP Requirements Hierarchy, can be obtained at SOP-L&D-001)
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled