Documentation Specialist

Doorsturen
 
  • Aanbod € 35,000 - € 50,000
  • Functiegroep Quality & Safety
  • Dienstverband Fulltime
  • Vacaturenummer 8891300
  • Locatie Boxmeer
  • Contract Detachering via YER
  • Branche Medical & Health

Over deze vacature

Alexx is an Animal Health Global Document Management System used to store Regulatory relevant documents across R&D. This system runs within the Veeva Vault Platform (cloud based software).

  • Alexx Migration
  1. Migrate documents both paper and electronic originals
  2. Migration of documents can include: external regulatory related documents from SharePoint sites, network shares (i.e. shared drives), and electronic media
  3. Scan (if needed) and classify documents to be made viewable in Alexx
  4. Reclassify already existing metadata on documents in Alexx from temporary storage to a permanent location

  • It will satisfy the requirements according to VICH GCP, FDA, EPA and OECD GLP regulations and guidelines

Functie

  • Request new study numbers for use in system, new products, contract organization names, when necessary
  • Classify, reclassify or upload documents into the systems appropriate business function areas (clinical, literature, preclinical, quality, regulatory, statistics, etc.) using the appropriate metadata
  • Contact the appropriate business function personnel to obtain information to correctly identify documents
  • Quality and/or completeness approval of documents
  • Assist associates with identifying and classifying of a document
  • Act as Alexx – Veeva Vault function/process point person for MAH-US
  • Back-up to the Global Archivist
  • Will assist with other Veeva Vault tasks as the project progresses
  • Other duties as required

The Documentation Specialist will report to the Alexx Program Manager, based in Boxmeer.

  • This position is vital to the overall outcome of this project. This position is required in assuring MAH research remains within all compliance regulations and standards in regards to document control.
  • Ensure document integrity throughout the process by accurately classifying/reclassifying metadata.

Bedrijf

In 1923, Saal van Zwanenberg started Organon, where at that time pancreatic porcine insulin was purified. It was the start of over 90 years of innovative pharmaceutical production in Oss. Approximately 1,500 colleagues currently work on the production and development of medicines at two locations.

Quality Operations (QO) at MSD Biotechnology operations Oss has the following sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents HUB. The QO Department must ensures adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of MMD products according to MMD Policies, Guidelines & Procedures and regulatory requirements by appropriate oversight and monitoring.

Provides day to day support for Biotech Operations, raising concerns if needed or directing users to do so. In co-operation with functional areas and in line with quality procedures and guidelines, support the handling of deviations, including implementation of CAPA’s. Partner with internal and global groups for technical issues resolution related to investigations or system issues.

Aanbod

We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to MSD.

Our benefits are very competitive and designed around your preferences:

  • A competitive salary depending on experience
  • Extensive set of tools to drive your career, such as a personal development budget, training and coaching
  • Healthy work-life balance

Profiel

  • Bachelor’s degree with 7 years’ experience in a related field and/or industry experience
  • Knowledge of FDA GxP, EPA GLP, and OECD GLP regulations and guidelines
  • Must have strong (English) communication, organization and writing skills
  • Ability to work independently, strong attention to detail/accuracy and perform in a multi-task environment
  • Affinity with scientific R&D documents within the life science industry is required
  • Expertise in Document Management Systems (Documentum, Veeva Vault) and/or repositories like SharePoint would be preferred
  • Expertise in Office related software (Microsoft Word, Acrobat, etc.)
  • Ability to apply strategic and analytical thinking to a project
Doorsturen