Trainee Qualified Person (Q.P.) in Scotland
Trainee Qualified Person
(with offer to pay for formal training to become a QP)
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