Pharmaceutical & Biotechnology

Documentation Specialist

  • Contract
  • Swords, County Dublin, Ireland
  • 42018182

The Role

PE Global are recruiting for a Documentation Specialist for our pharmaceutical client based in Swords, Co. Dublin This is an initial 9-month contract role with hybrid working options.

Job Responsibilities

  • Provide key operational support to the Upstream shift teams to ensure right first-time execution/delivery of manufacturing of batches
  • Support routine operations in the areas of safety and GMP compliance
  • Work with the Integrated Process Team (IPT) to ensure the effective and efficient on-time delivery of batch production in Upstream Operations. This requires the delivery of process excellence and reliability across all areas of the IPT.
  • Support Shift Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance and team training, including coordination of daily production activities.
  • Collate and analyse downtime tracking data and link to problem solving.
  • Provide Communication updates to manufacturing shift teams.
  • Co-ordinate and support Audits including preparatory work.
  • Coordinating and authoring Quality Notifications and Corrective and Preventive Actions (CAPAs). Ensuring accurate and timely documentation and updates to maintain compliance with quality standards and regulations.
  • Creation of Protocols.
  • Creation and revision of Standard operating Procedures (SOPs) Work Instructions (WI’s) as required

 

Education and Experience

  • Degree or 3rd level qualification (Science, Engineering).
  • Advanced soft skills e.g. Excel, PowerPoint to generate metrics, presentations as applicable
  • High level technical writing skills, Advanced PC skills such as Excel, MS Access, Word, PowerPoint, Familiarity with automated approval systems such as Trackwise, Documentum etc.
  • Excellent communication skills and ability to highlight constraints and resource challenges
  • Knowledge of Lean Six Sigma and Lean methodologies, with an understanding of regulatory requirements.
  • Self-motivated with excellent organizational skills
  • Working knowledge of Upstream processes is highly desirable.
  • Ability to interact with multiple stakeholders across numerous departments.
  • Ability to work independently and as part of a team.

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV to aisling.oleary@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***