(Associate) GMP Project Manager
The GMP Project Manager / Ass. Project Manager is prime contact for the customer and has a unique role in a link between CS and Quality Assurance from a documentation perspective. The role requires an in depth understanding of clinical trials supplies and the services that the company is able to provide and the ability to act as a conduit between Operations/CS and the client QA. Assisting in the timelines management – milestone tracking – with regards to GMP documentation. The role requires competent use of systems and SOPs and will be required to perform to company’s quality standards and timelines.
- Work with Packaging PM on project planning/tacking.
- Reviewing and approving Batch Records pre- and post-production according to client specific processes/SOP.
- Working with both the pre and post approval groups ensuring that the documents are in compliance with the customer specific requirements as well as SOP/GMP regulations.
- Compiling client QA documentation for their review and subsequent release.
- Main CS GMP contact with the client when reviewing/advising on document requirements – this includes Project Meetings at the customer site or company. Representation at kick off meetings as required by the customer.
- Development of processes e.g. labeling; sampling methodology for company and their client.
- Training both internally and externally on cSOPs and processes.
- Advisory role with the client on best practice within the industry.
- Works with internal QA to meet the customer requirements in regards to process improvement/compliance.
- Define and implementation of customer needs.
- Timeline Management – Milestone tracking – weekly Project updates to the customer.
- Internal: Team Leader / Sr. Manager Customer Services / Operations Head / QA Head
- External: Clients as required / Other subcontractors/vendors as required
Qualifications and Experience:
- Good level of advanced education and at least 12 month experience in clinical trial management as Associate Project Manager or appropriate position.
- In accordance with the GMP Project management skill/training matrix.
- Excellent communication and co-ordination skills and project co-ordination skills.
- Previous work experience, preferably in pharmaceutical environment.
- Ability to express detail in simple terminology, both written and verbal.
- Able to perform time management and handle work load.
- Fluent in both written and spoken German and English
- Relevant working/residency permit or Swiss/EU-Citizenship required