Description:
Working as part of the Quality Team, the Quality Specialist will support the business in ensuring compliance with Good Distribution Practice (GDP) and the requirements of ISO 9001.
Key Duties
- Participate in the external audit programme. This will involve conducting Principal Audits for UDD / UDC / UDW.
- Manage GxP Vendors
- Participate in regulatory audits, to include preparation, attending throughout the audit and involvement in the follow up of any findings
- Management of the internal audit schedule. Ensuring the schedule is adhered to and assisting the audit team to ensure the audits and any follow up actions are completed on time.
- Provide Quality support to the Document controller.
- Participate in the periodically review of Bona-Fides.
- Interaction with the HPRA and Marketing Authorisation Holders, ensuring compliance with regulatory and quality requirements.
- Provide training on aspects of QMS and ensure relevant personnel involved in GDP operations are trained and records maintained.
- Assist with deviations from GDP, identification of root cause and ensure CAPAs are identified and implemented as defined.
- Support the Change Control Programme.
- Principal management, including T&Q’s, KPI’s and other requests.
- Keep up to date on regulatory requirement and changes to regulations
Other Duties Not Identified Above May Be Required.
Key Experience / Skills / Education
- Demonstrates good verbal, written, and interpersonal communication skills.
- Strong organizational skills, including ability to follow assignments through to completion.
- Relevant experience (3yrs +) working in the pharmaceutical or regulated distribution industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
- Knowledge of applicable regulatory requirements including working knowledge of current Good Distribution Practice (GDP).
- Qualification in a life science and/or willingness to complete