QA Operations Specialist

A newly founded biotechnology company is currently seeking a QA Operations Specialist to join their office in Reykjavik. This organisation is fast becoming a pioneer and leader in the field of biosimilars, with a growing portfolio of developed and manufactured products across the value chain, from cell line development to commercial manufacturing. This position represents an exciting opportunity to work with an already prestigious and dynamic company.

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.
• Performing QA reviews and approving product specifications and master batch records.
• Reviewing batch records and associated documents from API before a formal release to the next manufacturing step.
• Performing QA review and approving records and reports related to area of responsibility.
• Drafting, reviewing, and approving Quality Operations SOPs and documents from areas of responsibility.
• Overseeing QA review and release of Cell Banks.
• Acting as the QA approver for any quality records related to API processes.

Skills and Requirements:

• Educated to at least degree level in medicine, pharmacy, or life sciences; higher qualification (eg MSc, PhD) preferred.
• An extensive track record (approx. 2-4 years) of previous medical writing experience gained within a medical communications agency or scientific publishing environment.
• Ability to produce "de novo" high quality and accurate scientific copy in a range of writing styles.
• Understanding of the science and data behind client marketing messages.
• Excellent written English, attention to detail and oral communication skills (including presentation skills) - comfortable dealing with KOLs/clients/senior company staff.
• Completed ABPI training.
• Good knowledge of strategic medical communications-understanding pharmaceutical industry drivers.
• Fully understands and demonstrates adherence to international, national and industry specific compliance guidelines (IFPMA, ICJME, GPP, ABPI, other specific SOPs)
• 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 Steven Fuller at +44 203 854 2630 or upload your CV on our website - www.Proclinical.com.

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.

#LI-SF1

#Compliance/Quality