Hobson Prior are looking for a QA Biologics Manager to provide advice and support on operational and general QA activities to the organisation's teams working on Drug Substance and Drug Product development, Technology transfer, manufacture and submission preparation. You will join a top biopharmaceutical organisation in Slough on a contract basis.

Job Responsibilities:

• Deliver advice and support on operational and general QA activities to UCB teams working on Drug Substance and Drug Product development, Technology transfer, manufacture and submission preparation.
• Review and approval of project documentation.
• Review and approve analytical, DS and DP CMC submission sections.
• Work closely with Technical Operations teams to ensure that all QA services for the project are provided in an effective and efficient way.
• Ensures free flow of information to the appropriate stakeholders.

Key Skills:

• Demonstrates initiative and an ability to help team and others solve problems creatively.

Requirements:

• A minimum of 8 years working in the pharmaceutical biologics industry in a quality assurance position. Operational GMP experience would be a distinct advantage.
• Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations together with quality principles and techniques.
• Understands practical applications of GMP, compliance principles and theories incl. risk management.
• In-depth knowledge and understanding of applicable regulations, quality principles, relevant business processes and techniques.
• Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the business.

Experienced in one or more of the following:

• Regulatory submission preparation for biological products
• Ich q2 analytical method validation principles and general analytical techniques
• Gmp process validation
• Ds and/or dp process manufacture for biological products

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.