QA Executive

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