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Qualified Person / Compliance Officer

Job Title: Qualified Person / Compliance Officer
Contract Type: Permanent
Location: Galway
REF: 93781
Job Published: 3 months ago

Job Description

Contact: Bimi Felix
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.

Basic Summary:
  • 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.

Person Specification:
  • 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 /
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