Project Specialist

Vor 5 Tagen

Dresden, Deutschland PCI Pharma Services Vollzeit

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.

Job Title: Project Specialist - Berlin
- Department: Production (Operations)
- Reporting to: Clinical Planning Manager
- Responsible for (staff): None
- General Purpose of Role: Creation of operational documentation, and use of ERP system to facilitate the packaging and release of product(s), within client expectations and timelines.
- Main 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.-
- Work towards achievement of personal development goals.-
- Where required, undertake tasks and projects outside the job holder’s area of responsibility.- Outcomes of Role:
- The ability to generate and translate documentation to facilitate in the packaging and release of products.-
- Support JDE transaction to allocate work orders-
- Post completed Work Orders in JDE for Doc Metrics and BillingSpecific Knowledge / Skills Competence:
- Business or science degree or equivalent qualification- Several years of experience in a similar role, preferably a third-party packaging or pharmaceutical environment- Excellent interpersonal skills to ensure a professional and courteous manner when dealing with external and internal customers- Strong written and verbal communication skills- Flexibility or the ability to adapt, react quickly and deal with change in a fast-paced environment- Proficient in the use MS Office Packages and ERP systems (ideally JDE)- 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

Behavioural Competencies:
- Team work.
- Self-motivation / achievement drive.
- Conscientiousness.
- Self Confidence.
- Analytical thinking and Problem Solving.
- Adaptability.
- Initiative.
- Judgement and decision making.
- Conceptual Thinking.
- Attitude embracing company vision and values.

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._

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