Our client has an urgent need for an experienced QA manager to join the team REMOTELY INTIALLY for an initial 12-month contract.
This position will support operational Quality Assurance activities for our client’s biological development projects.
Duties will involve;
• Review and approval of project documentation, for example:
o Technology Transfer protocols and Reports
o Manufacture and analytical testing (process description, master batch records, analytical methods, specifications)
o Quality Agreements
o Process development studies
o Analytical validation studies according to ICH Q2
o Stability studies
o Protein characterisation
o Mammalian working cell banks (preparation, testing, characterization)
o Review of completed CMO batch documentation
o Deviations, Change controls, CAPA
• 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.
EDUCATION & EXPERIENCE REQUIRED
• 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.
• Experienced in one or more of the following:
o regulatory submission preparation for biological products
o ICH Q2 analytical method validation principles and general analytical techniques
o GMP process validation
o DS and/or DP process manufacture for biological products
• 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
• Understands practical applications of GMP, compliance principles and theories incl. risk management
Please send me your most up to date resume or call me anytime to discuss in more detail.
Glen Fairbrother on 02079401212 / glenf@msigroupltd.com
