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Research Quality Assurance Officer - Contract

MNA Recruitment (Pty) Ltd • Other • Middelburg, Mpumalanga, South Africa • 5h ago

A leading pharmaceutical company has a contract position for a Research Quality Assurance Officer.
Role:

Quality assurance for veterinary research studies under GCP and GLP accreditation.

Education requirement:

Any undergraduate scientific qualification.

Experience requirement:

Experience of conducting GCP and GLP quality audits for research studies.
Extensive knowledge of VICH and GLP guidelines.
Candidates with no GCP or GLP auditing experience should have extensive ISO auditing experience.

Duties:
QA duties include:
Auditing of studies according to OECD GLP principles and VICH GCP principles

This includes proof reading and auditing study protocol / reports and amendments for compliance with specified scientific guidelines and the principles of OECD GLP and VICH GCP
Audit and review study raw data along with the reporting of this data
Audit critical phases of the studies
Conduct test site audits when required
Conduct facility audits to monitor, report non-compliances to maintain the quality system at MRU
Train personnel on the principles of GLP and GCP
Act as monitor in GCP studies when required
Serve on the AEC when required
Assist with regulatory inspections where required and lead the SANAS accreditation inspections
Should have basic knowledge of validating computer systems to ensure the correct validations are done for systems implemented on site

Oversee the documenting of quality system at MRU through Standard Operating Procedures (SOPs)

Regular review and updating of SOPs used at MRU and the implantation of global company procedures / policies
Ensure the SOP complies with local SOP requirements before finalisation
Assist with the distribution of SOPs in the system

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on />Should you receive no feedback within 7 days, please accept your application as unsuccessful.

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