Quality Systems

1 month ago

Worthing West Sussex, United Kingdom Hobson Prior Full time

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. 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.
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.
Acquaintance within Quality Systems, for example: change control, non-conformances and CAPAs.
Computer literacy.
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