Quality Specialist – QMS

Job Title: Quality Specialist – QMS
Location: Tredegar
Department: Quality
Reporting to: Senior Quality Specialist – QMS
Responsible for (staff): N/A

General Purpose of Role:

  • To ensure the effective administration, monitoring and completion of Quality System activities at Penn Pharma (PCI Tredegar).
  • The job holder is required to work on their own initiative and largely independently on key responsibilities under the supervision of the Head of QMS.
  • The nature of the role of QA Specialist – QMS requires consistency of attitude and behaviour from the job holder to all aspects of Pharmaceutical Quality Assurance and the constant pursuit of excellence and efficiency throughout the organisation.
  • The role demands technical and regulatory knowledge, high standards of attention to detail and the desire to see tasks through to completion.

Main Responsibilities:

  • Conduct Internal Audits to an agreed programme.
  • Co-ordinate and complete External Vendor Audits to an agreed programme.
  • Track corrective and preventative actions from Internal and External audits. Where possible, close corrective and preventative actions or provide help and advice to other departments to assist with closure.
  • Use Penn software system; to raise, monitor, implement and close corrective and preventative actions.
  • Maintain and update the Approved Supplier List.
  • Complete assessments for of suppliers, where necessary.
  • Schedule audits to comply with Penn procedures, risk assessments and in the most cost effective way.
  • Report relevant Key Performance Indicators.
  • Conduct GxP training to site personnel and contribute to GxP training packages where necessary.
  • Ensure timely review and approval of relevant Quality documentation.
  • Collation of the company Quality Management Review (QMR) information for review by Senior Management.
  • Proactively seeking opportunities for continuous improvement.
  • Use of Quality Risk Management systems to ensure that risks are adequately controlled in accordance with current requirements.
  • Ensure appropriate investigations of deviations, errors, complaints, failures and adverse events requiring documented review and action.
  • To review non-compliance identified by audit, deviations and complaints and use technical/professional judgement to make appropriate product quality decisions (in association with site QPs) and initiate and promote quality improvements.

Specific Qualifications:

  • A minimum of a scientific degree or Quality Assurance qualification with demonstrated experience in a regulated pharmaceutical environment.

Previous Work Experience:

  • Experience in a similar role in the pharmaceutical industry with up to date credentials relevant to both investigational (clinical trial) and marketed (commercial products).

Specific Knowledge / Skills Competence:

  • Excellent interpersonal skills being able to communicate effectively with a wide range of individuals and groups.
  • Proven ability and desire to continuously improve, by seeking new approaches and generating ideas.
  • Proven ability to plan work effectively, by taking a long-term view and developing structured action plans to meet business objectives.
  • Must be able to effectively manage multiple tasks simultaneously.
  • Must be a completion driven individual, with the attitude to drive projects to completion in considerable detail.
Posted on Categories EU, EU Tredegar, Vacancies

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