Documentation Specialist

2022-09-15 16:06:042050-02-20Team Horizon
Job TypeContractor
SectorQualityOperations & ManufacturingRegulatory
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref#1002612
Job Views333
Documentation Specialist – Team Horizon
We are seeking applications for an experienced QC Documentation Specialist (6-month contract) for our client, who are a leading biopharmaceutical company. In this role you will be responsible for managing routine documentation workflows, authoring quality documents and actively participating in continuous improvement in documentation management.
In this role, you should have excellent technical writing skills, relationship building and problem-solving skills. A high attention to detail and excellent verbal and written communications skills are vital to success in the role. High proficiency in MS word is essential.
Why you should apply:
  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  • Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.

What you will be doing:
  • Primary duties of the position are focused on documentation management for the QC Lab Support Team.
  • Writing and revision of Standard Operating Procedures (SOPs) and related documents.
  • Track documents through approval process and work with approvers to deliver documents in-line with Quality Control project plans.
  • Identify process improvements within the function and drive the initiative forward to implementation and effectivity
  • Comply with internal SOP’s, standards and associated training
  • Responsible for assigned CAPA’s, Change Controls and Deviations program and initiation of Corrective Action plans in the Alexion Quality Management System, TrackWise.
What you need to apply:
  • Degree undertaken in chemistry or biological science with a preference for Analytical Chemistry or Biochemistry.
  • Experience of SOP authoring and document management processes.
  • Excellent communication, interpersonal and organizational skills.
  • Ability to work well both independently and in a team environment.
  • Ability to prioritize work and multitask, working closely with the QC Manager-Stability (Lab Support).
  • Conducts work in compliance with cGMPs, ICH guidelines and safety and regulatory requirements.
  • Represent Alexion Pharmaceutical interests, objectives, and policies in a professional manner.
  • Takes a structured, analytical approach to problem solving.
  • An understanding of the methodology and analytical techniques used for biopharmaceutical testing is preferred.
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