Accessibility Links

Documentation Specialist

  • Job reference: 935953
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 09/06/2021

Orion Group Life Sciences have an exciting opportunity for a Documentation Specialist for our Multinational Biopharmaceutical client in Cork on an initial 11-month contract.

The Documentation Specialist is accountable for the smooth execution of all appropriate documentation associated within the Restructuring Group responsible for the decommissioning and deletion activities associated with legacy products on site.

He/She will contribute to the High-Performance culture within the group by providing a flexible, accurate service to enable the achievement of MMD key priorities.

The Documentation Specialist is an active member of the cross functional Restructuring Team, providing support, guidance and expertise to ensure the success of the group.

The Documentation Specialist will participate and comply with the MMD Quality Management System (QMS) requirements, including ownership, as relevant to you.

Primary activities/responsibilities:

  • Updating/deletion of documents through the MIDAS system.
  • Preparation of change control documentation on TrackWise System.
  • Tracking of GCM tasks on TrackWise System.
  • Processing of documentation through the Change Control System.
  • Regular updates to Tier boards with various metric information such as Incidents, Investigations, CAPAs, GCM tasks, EHS actions, Safety metrics, etc.
  • Generation and control of Purchase Orders on SAP.

Experience/Qualifications:

  • Minimum Leaving Certificate with a high level of achievement.
  • Desirable: Qualification in a science/engineering/technical subject.
  • Desirable: Evidence of Continuous Personal Development.
  • Desirable: Six Sigma Yellow Belt.
  • Knowledge and experience of GMP, GDP and DI in a pharmaceutical environment.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality, Engineering, Tech Services etc).
  • At least three years experience in the Pharmaceutical industry or a similar regulated environment.
  • Multi-tasking in a fast-paced project environment
  • Independent, self-confident worker with good initiative
  • High level technical writing skills and good organization skills
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Desirable experience - SAP, MIDAS, TrackWise, Change Control
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.

For more information on this role, call Beatriz Olmedo on +34 602 492 025 or email beatriz.olmedo@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 935953


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

Similar jobs
QA Associate 30949
  • Salary Negotiable
  • Job type Contract
  • Location Dún Laoghaire, Dublin
  • Description Orion Group Life Sciences have an exciting opportunity for a QA Associate for our Multinational Biotechnology client based in South Dublin on an initial 12-month contract with the potential to extend
QA Documentation Specialist
  • Salary Negotiable
  • Job type Contract
  • Location Cork
  • Description We at Orion Group are currently recruiting a QA Documentation Specialist on behalf of one of our Multinational Biotech Client in Cork on an initial 11-month contract
Technical Writer 30919
  • Salary Negotiable
  • Job type Contract
  • Location Dún Laoghaire, Dublin
  • Description Orion Group Life Sciences have an exciting opportunity for a Technical Writer for our Multinational Biotechnology client based in South Dublin on an initial 12-month contract with huge potential to