Clinical Planning Specialist - Dresden, Deutschland - PCI Pharma Services

PCI Pharma Services

Geprüftes Unternehmen

Dresden, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 intercompany 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
Team player
Selfmotivation / 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.

Join us and be part of building the bridge between life changing therapies and patients.

Let's talk future

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._