Job Title: Quality Specialist – QMS
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.
- 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.
- 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.