QC Documentation Specialist

  • Contract
  • Dublin

Website TPM04548

Summary:
A QC Documentation Specialist is required for a biopharmaceutical company in West Dublin. The incumbent will be responsible for managing routine documentation workflows, authoring quality documents and actively participating in continuous improvement in documentation management.

Responsibilities:

  • 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.
  • In this role, you should have excellent technical writing 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.
  • 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 affectivity.
  • 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 TrackWise.

Qualifications & Experience:

  • Degree undertaken in chemistry or biological science with a preference for Analytical Chemistry or Biochemistry.
  • Computer skills (MS Office, MS Excel) or comparable word-processing and spreadsheet applications is preferable.
  • 1-2 Years working in pharmaceutical quality operations.
  • Experience of SOP authoring and document management processes.
  • 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 our client’s 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.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.