Telephone: 086 8395533
Qualified Person / Compliance Officer
Our client, a medical device company in Galway are currently looking to recruit a Qualified Person / Compliance Officer for their site.
- To ensure that all products are released in accordance with GMP guidelines and the relevant marketing authorisations.
Essential Duties and Responsibilities:
Responsibility for batch release as per EU guidelines by ensuring the following requirements have been met:
- The batch and its manufacture comply with the provisions of the marketing authorisation (including the requirements for importation where relevant);
- Manufacture has been carried out in accordance with GMP (in the case of an imported batch that it has been manufactured to standards equivalent to EC GMP);
- The principal manufacturing and testing processes have been validated (account has been taken of the production conditions by review of the relevant documentation);
- Any deviations or planned changes have been duly authorised. Any changes requiring variation to the marketing authorisation have been notified and authorised by the relevant authority.
- All the necessary checks and tests have been performed;
- All necessary production and quality control documentation has been completed and endorsed by the appropriate staff;
- Forward any incoming reports (whether it is through post, e-mail, fax or in person) regarding pharmacovigilance / adverse action reports to the relevant QPPV in a timely manner.
- All audits have been carried out as required by the QA system;
- Take into consideration any other relevant factor that may affect the quality of the batch.
- Forward any incoming reports regarding Pharmacovigilance/Adverse Action Reports to the relevant QPPV in a timely manner.
- Partake in Pharmacovigilance audits as required.
- Conduct Routine Quality Audits of the facility to ensure compliance with current EU GMP, be proactive in resolving issues which may arise.
- Ensure the Internal Audit schedule compliance as per schedule.
- Ensure the preparation and compliance of the annual GMP site training programme.
- Conduct External audits, compile reports and manage associated responses as required.
- Management and assistance with the site change control system.
- Management of the customer complaints system and associated CAPA’s.
- Quality review and approval of validation protocols and reports.
- Participate in regulatory/customer audits of the site as appropriate and when required
- Quality approval of rejection notices as appropriate and when required.
- Signing GMP declaration forms for API suppliers as appropriate and when required.
- Investigate and approve QC and stability out of specifications.
- Provide technical support for Product Launch and existing Products, ensuring compliance with the registered dossier
- Review /lead Process investigations and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
- Ensure Process transfer is documented and conducted in accordance with Regulatory Standards.
- Quality review and approval of manufacturing documentation for the company & third party contract manufacturing.
- Provision / Updating of existing Quality Procedures in order to ensure compliance with EU GMP
- Contributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.
- Preparation of Key Performance Indicators for the Quality Assurance department and also assisting in the maintenance of records for the company KPIs as per Quality Management review requirements.
- Ensure timely feedback on customer/production queries as appropriate.
- Preparing product quality review schedule and reports for the company and third party contract manufacture products & ensuring compliance.
- Assist in product investigations and ensuring risk assessment approach is applied
- Management of the deviation & CAPA’s system.
- Collating weekly & monthly trends and assisting Visual Management & the Quality Material Review Board meetings.
- Degree in Science discipline or equivalent.
- Minimum of 5 years’ Quality Assurance experience within the pharmaceutical industry; B.Sc. degree as a minimum requirement
- Qualified person named on licence, preferably in solid dose facility
- Strong organisational skills / ability to prioritise work
- Proven track record as a team player
- Excellent communication and presentation skills with a hands-on approach
For further information on this Qualified Person / Compliance Officer role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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