Hobson Prior are currently working with a specialty biopharma organisation who are focused on the advancing and manufacturing biosimilar medicines. Our client is looking for a QA Specialist to join them on a permanent basis.

Job Responsibilities:

• Working as a QA contact person with drug product manufacturing as an area of responsibility.
• Provide QA support to project teams and perform review of regulatory submission dossier documentation, prior to obtaining regulatory approval.
• Provide QA expertise during the investigations of Deviations or OOS; and QA approve these and their related CAPAs.
• Contribute to the preparation of inspections as per defined and agreed role.
• QA review and approval of QMS documentation.
• Review of batch records and associated documents from drug product manufacturing department before a formal release to the next manufacturing step
• Contribute to the development, approval and maintenance of quality policies and procedures as required

Key Skills:

• Thorough understanding of Quality Systems and GMP environment of pharmaceutical manufacturing
• Excellent written and oral communication skills both in English
• Strong collaboration skills and ability to build partnerships internally and externally
• Critical thinking and evaluation of process problems
• Collaborative team player

Requirements:

• Significant QA or manufacturing experience (5-10 years) working with sterile manufacturing.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.