Summary of Position
The QP is expected:
To undertake the duties of Qualified Person as specified in Article 51 of Directive /83/EC and in accordance with requirements of Annex 16.
To ensure Curium compliance with the requirements of Good Manufacturing Practice.
To ensure that every batch of PET radiopharmaceuticals has been manufactured and tested in compliance with:
The laws enforced in the Irish State in respect of such product
The provisions of Curium’s or any contract giver license
The provision of product authorisation and other standards, which relate to said product.
To certify and register that each production batch of the medical preparation to which the licence relates satisfies the above requirements as soon as practical after each such batch has been manufactured.
Essential Functions
1. Main Role:
Review and evaluate batch manufacturing on site providing immediate decisions required for short lived products.
Authorise batch disposition to meet the needs of the business (Annex 16 GMP Regulations) and regulatory requirements in timely manner.
Ensure testing is carried out, according to validated analytical methods and EU Pharmacopoeia specifications.
2. Quality Management:
Contribute to the Quality Management system (QMS) for the production of PET radiopharmaceuticals.
Strictly adhere to GMP and safety protocols laid down by the HPRA, MHRA and EPA in accordance with issued licenses. Corresponding adherence to quality documents and local rules developed by Curium in conformity to such licensing requirements.
To provide quality influence and guidance to all aspects of workflow.
3. Quality Documentation:
Contribute to the preparation and approval of process deviations, out of specification reports and change controls paying particular attention to ensure that problems are addressed in compliance with GMP and company procedures in a timely manner.
Contribute to and approve all other GMP and Quality related documents.
Operate within SOPs and make recommendations for changes necessary for quality improvements.
4. Projects & Products:
Support the development of new products technologies within Curium.
Participate in corporate quality initiatives, as required.
5. Marketing Authorisation:
Ensure the Manufacturing Authorisation is up to date and adhered to at all times.
6. Complaints:
Monitor the nature, extent and frequency of Complaints.
Ensure complaints are properly investigated and closed out in a timely manner.
7. Withdrawal/ Recall:
Co-ordinate the Withdrawal and Recall procedures.
8. Validation:
Ensure appropriate analytical method validation is carried out for all non-compendial test methods.
Support site validation activities ensuring that regulatory requirements are met.
9. Product Disposition:
Ensure the dispositioning of 18F products is completed in a timely manner.
10. Auditing:
Co-ordinate Curium’s internal and external auditing programmes.
Prepare audit reports and ensure all follow up actions are completed in a timely manner.
11. Computer System Validation:
Ensure computer systems in use at Curium meet the criteria of Annex 11.
Monitor the procedures in place for the use of computer software and systems at Curium to ensure compliance with regulations.
12: Training:
Participate in relevant training courses.
Provide training and support for others in the area of GMP and the Curium Quality System.
13: Customers:
Assist in keeping customers informed of any supply related issues in a timely fashion.
14. Pharmacovigilance:
Assist with the PV system in ensuring that Curium is in compliance with Good Pharmacovigilance (GVP) at all times.
Requirements
1. Third level qualification in a scientific discipline – pharmacy, medicine, physics, chemistry, pharmaceutical chemistry and biology.
2. Meet the education requirements for the role of a Qualified Person such as a diploma in Pharmaceutical Manufacturing Technology or equivalent.
3. Minimum 3 years’ experience as QP on a manufacturing license for aseptic sterile products.
4. cGMP experience with relevant work experience acting as Qualified Person, named on the Manufacturer's/Importer's Authorisation (MIA) ; consideration will be given to other relevant experience and education
5. Valid independent work permit