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Trainee Qualified Person (Q.P.) in Scotland

Trainee Qualified Person

(with offer to pay for formal training to become a QP)

 

Summary

The Trainee QP is responsible for the management and running of the Quality department at the manufacturing facility. Responsibilities include setting up, maintaining and improving GMP compliant (2003/94/EC) Quality Management Systems within our clients business, and for ensuring these systems are compliant, implemented, and both user-, client-, and business- friendly.

 

Key Responsibilities & Duties

QA responsibilities include but are not limited to:

  • Co-ordinate and approve equipment and facility qualification, validation and maintenance in accordance with appropriate regulatory and usage requirements.
  • Prepare and review Quality Agreements with clients defining responsibilities of the Contract Giver and Receiver in terms of Quality and compliance requirements.
  • Assess, inspect (where required) and approve contractors to ensure they meet the company’s and Regulatory Authority compliance, technical and service requirements (Ref N-QSOP005).
  • Lead client and Regulatory inspections, and co-ordinate any observations to ensure that they are adequately addressed.
  • Review and approve all master study related documents and SOPs to ensure compliance to the appropriate Regulatory requirements.
  • Ensure change control of master procedures includes appropriate review and authorisations.
  • Maintain, review and approve all regulated study related and SOP master documents within the facility
  • To approve or reject, as he sees fit, starting materials, packaging materials,  intermediate, bulk and finished products used within the contract testing or manufacturing facilities.
  • To ensure that all necessary testing is carried out and the associated records evaluated
  • To ensure the required initial and continuing training of staff in quality systems is carried out.
  • Dotted line management of the Document Control/Archivist roles which is managed by the Document Control Manager who reports to the Associate Director of Quality.
  • Policy and procedure creation
  • Perform internal audit functions (process audit, assay audit, documentation audit, etc)
  • GxP statement and approval of batch certificates / reports
  • Perform supplier assessments and lead supplier inspections
  • Assess impact of deviations and provide guidance, support and co-ordination of  CAPA
  • Co-ordinate any client and supplier related quality issues
  • Review and approval of Operational Policies and procedures
  • Recruitment of  adequately qualified personnel for the Quality department
  • Perform training and assessment in Quality issues as required
  • Management and line management responsibilities as defined in SOPs
  • Provide advice / guidance on any compliance issues (e.g. complaints, OOS, deviations, CAPA, etc)
  • Writing and approval of compliant documentation
  • Advise and approval of validation requirements (facility, equipment, software, materials, personnel, etc) according to GxP requirements

 

Qualifications / Skills required

  • A degree in a relevant scientific discipline
  • At least 5 years Quality experience, preferably within a GMP or GLP environment.
  • Line Management experience
  • Thorough understanding and experience applying EU and US GMP or GLP regulations
  • Extremely organised approach is required coupled with the ability to influence without authority

Reference

PTQP

Location

Scotland
Motherwell

Salary

£35,000 to £50,000
plus training costs

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