- 21 november 2018
- vacaturenummer: 9060482
Yacht Life Sciences has a vacancy for a Senior Manager Document Control - EU.
We are seeking a highly motivated individual as a Senior Manager Document Control EU. You will work with the Quality Systems team in supporting the efforts in an exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Director of Quality Systems in EU.
- As a Senior Manager Document Control EU you will provide oversight of the company's clinical GMP Document and Records Management system. This position will be located at the manufacturing site, and will establish the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site. This involves writing and maintaining document control procedures and participating in the development and roll-out of document control tools.
- Manage document control processes and systems for GMP activities in compliance with internal procedures and policies as well as regulatory requirements.
- Manage the routing, review, approval, distribution and archival of new and revised controlled documents.
- Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures.
- Establish and maintains records management system including secure storage, retrieval, retention and destruction.
- Develop and deliver training and/or site guidance on document and records management roles, and processes.
- Define resource requirements; assign resources to tasks; manage assigned team.
- Bachelor’s degree and a minimum of 10-12 years of experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
- Knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Minimum of 3-5 years of management experience
- Strong knowledge of GMP, SOPs and quality systems
- Excellent writing and editing skills
- Works on multiple assignments in collaboration with various department system owners
- Advanced skills with MS Office applications Word, Excel, Access, as well as Adobe Acrobat
- Ability to communicate and work independently with scientific/technical personnel
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Direct and full-time employment at our client
Our client is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998
Werken voor Yacht
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Uiteraard staat deze vacature open voor zowel mannen als vrouwen.
Deze vacature wordt via YACHT aangeboden. Het solliciteren en verdere contact verloopt via YACHT.