QA Operations Specialist

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. Iceland
Posting date: 09 May 2019

A speciality biopharmaceutical company is currently recruiting a QA Operations Specialist to join their office in Reykjavik. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing. This is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.

Job Responsibilities:

  • Working as a QA contact person with API as an area of responsibility.
  • Providing general QA expertise and support for API.
  • Providing QA expertise during the investigations of Deviations or OOS; and QA approving these and their related CAPAs.
  • Supporting and approving Change Control records.
  • Contributing to the preparation of inspections as per defined and agreed role.
  • Participating in CAPAs resolution of inspection findings.
  • Reviewing and approving QA of product specifications and master batch records.
  • Reviewing batch records and associated documents from API before a formal release to the next manufacturing step.
  • Review and approving QA of records and reports related to area of responsibility.
  • Drafting, reviewing, and approving Quality Operations SOPs and of documents from areas of responsibility.
  • Review QA and releasing of Cell Banks.
  • QA approving any quality records related to API processes.

Skills and Requirements:

  • Degree educated in a relevant discipline.
  • Previous quality operations experience in a GMP environment.
  • Biologics experience desirable though not essential.
  • Demonstrable project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Owen Bach at +44 203 826 1330 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.