Job Information
PCI Pharma Services Clinical Planning Specialist in Grossbeeren, Germany
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.
Role and Responsibilities
Ensure the one time delivery of Project Set-Up activities including but not limited to:
Creation of Projects in the ERP system.
Creation of Item Codes and linking of Item Codes for inter-company projects.
Creation of Bill of Materials in the ERP.
Issuing and completion of Works Orders.
Preparation and maintenance of Master Batch Records Support project specific and production queries in dual language for MHRA and LAVG
Work closely with Project Managers, QPs and other Operational departments.
generate and translate documentation to facilitate in the packaging and release of products.
Post completed Work Orders in JDE for Doc Metrics and Billing
Create and analyze KPIs/ metrics for the Operations department
Support and coordinate continuous improvement projects for the Operations Department
Support and work on compliance activities (EVENTS, DEVIATIONS, etc) in the eQMS system
Support and act as Deputy for Clinical Planning Manager, including communication and alignment with other departments like Project Management and Quality
Qualifications and Education Requirements
Minimum of 3 years experience in production control/ production planning or similar activities, preferably in pharmaceutical industry
Experience with batch record creation
Team player
Self-motivation / achievement drive.
Analytical thinking and Problem Solving.
Adaptability.
Initiative.
Judgement and decision making.
Conceptual Thinking.
Preferred Skills
Proficient in the use MS Office Packages and ERP systems.
Excellent written and verbal communication skills in German and English
Excellent attention to detail.
Strong time management and organisational skills.
An understanding of Quality Standards including GMP, GDP and Good Documentation Practice.
#LI-AB1
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