Job Description

Role of QA Executive:

\xe2\x9d\x96 To work as part of the team to ensure the company KPI\'s are achieved

\xe2\x9d\x96 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

\xe2\x9d\x96 To help maintain compliance with the principals of Good Manufacturing Practices in all

activities associated with the MIA.

\xe2\x9d\x96 To manage all Technology transfers projects with CMO\'s to which they are assigned.

\xe2\x9d\x96 Ensure CMO\'s continue to manufacture in compliance post technology transfer

\xe2\x9d\x96 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:

\xe2\x9d\x96 Provide monthly updates of progress against KPI\'s

\xe2\x9d\x96 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

\xe2\x9d\x96 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

\xe2\x9d\x96 To act as main contact for technology transfer of licenced products with CMO

\xe2\x9d\x96 Review all completed batch documents received from CMO\'s/QC sites prior to QP release

\xe2\x9d\x96 Address any issues identified with CMO\'s/QC site prior to QP release

\xe2\x9d\x96 Active participation in internal, external, and competent authority audits

\xe2\x9d\x96 Active participation and presentation during meetings

Miscellaneous:

\xe2\x9d\x96 To comply with Health and Safety Regulations.

\xe2\x9d\x96 To maintain the confidentiality of all information relating to the business activities of the

companies mentioned.

\xe2\x9d\x96 To attend relevant training courses as required by the Company.

\xe2\x9d\x96 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

CPL