Hobson Prior are currently looking for a QA Systems Manage (IT/Data Integrity) to join a brilliant biotech organisation on a permanent basis with hybrid working available. Our client is focused on changing lives with groundbreaking treatment.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will assist with compliance on all GMP/GDP and GCP regulations guaranteeing adherence to GxP and data integrity legislation.
• Serve as the System Owner /Administrator role for GxP IT systems that reside within QA.
• The ideal candidate will carry out evaluations of data integrity documentation periodically and as needed.
• Offer aid for any other quality systems which involves Non-Conformances, CAPA, QTAs, as applicable connected to GxP IT systems.
• Collaborate with IT associates assuring suitable oversight of IT systems.
• Mediate with IT division associates linked to GxP impact and GxP compliance of IT systems and impact assessment of pertinent change controls.
• Any other assigned duties.

Requirements:

• Experience with TrackWise, LIMS and Documentum and/or any other QMS systems.
• Acquaintance global GxP, e.g., FDA CFRs, EU, 'Third countries' other than the UK.
• Familiarity within a pharmaceutical manufacturing, testing or quality assurance setting in a similar position.
• Prior involvement with IT QA, maintained by knowledge of IT QA compliance needs and procedures, and high level of familiarity with numerous GxP IT systems.
• Capabilities of a data integrity SME as well as familiarity with systems validation.
• Interpersonal, influential and communication skills both verbally and in writing.
• Shareholder management abilities with scientific and technical expertise.
• Comprehension of GxP suitable in the UK.
• Acquaintance within Quality Systems, for example: change control, non-conformances and CAPAs.
• Expertise on basic statistical tools and strategies.
• Computer literacy.
• Capable of assimilating information and exhibiting a high attention to detail.

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.

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