Overview
Reference Number: JO-2307-519835
QA Executive
Rate: Negotiable
Job Type: Permanent
Location: Hatfield
Role of QA Executive:
❖ To work as part of the team to ensure the company KPI’s are achieved
❖ To provide support and assistance to QA Manager in maintaining PQS and all activities/
functions of RMIA and SCD(UK) Ltd as a MA holder
❖ To help maintain compliance with the principals of Good Manufacturing Practices in all
activities associated with the MIA.
❖ To manage all Technology transfers projects with CMO’s to which they are assigned.
❖ Ensure CMO’s continue to manufacture in compliance post technology transfer
❖ To ensure batch documents are reviewed prior to QP release
Main Responsibilities:
To assist the QA Manager where required including but not limited to the following:
❖ Provide monthly updates of progress against KPI’s
❖ Work with the QA team to:
• Update, maintain and distribute the Standard Operating Procedures
(SOP’s).
• Updating and maintaining all PQS/ QA tracking tools / logs.
• Review and compilation of Product Quality Reviews, Risk Assessments, Reports
• Management of product complaints and active participation in recalls.
• Active use of all quality functions within the PQS – change controls, deviations and
CAPAs.
• Filing and archiving of all Quality-related documents
❖ Specific for Tech Transfer/ Project Management:
• Review and respond to Change requests, Deviations and CAPA’s from CMO’s
• To liaise internally with relevant QP’s to ensure regulatory requirements are
assessed and documented
• Collate information required for; and liaise with the Rx Regulatory team for variation
submissions
• AMT transfer with EU/UK QC laboratories
❖ To act as main contact for technology transfer of licenced products with CMO
❖ Review all completed batch documents received from CMO’s/QC sites prior to QP release
❖ Address any issues identified with CMO’s/QC site prior to QP release
❖ Active participation in internal, external, and competent authority audits
❖ Active participation and presentation during meetings
Miscellaneous:
❖ To comply with Health and Safety Regulations.
❖ To maintain the confidentiality of all information relating to the business activities of the
companies mentioned.
❖ To attend relevant training courses as required by the Company.
❖ To perform other duties as directed by the Company.
Candidate must have:
• Hold a suitable degree in a scientific subject
• Minimum 5 years’ experience in a GMP/MIA environment, preferably with QA
experience
• Project management experience highly recommended.
• Good interpersonal skill
• Excellent written and communication skills
• Competence in Microsoft Office
