Quality Compliance Specialist

at  United Drug

QUALITY COMPLIANCE SPECIALIST

This job description sets out the scope of the role of the Quality Compliance Specialist, with the main duties of the position at the date when it was completed. It does not include or define all responsibilities or duties which the post holder may be expected to carry out. Duties may vary from time to time without changing the nature of the post or the level of responsibility. The post holder may also be required to carry out any other duties to co-operate with the general work of the organisation, as required by their line or department manager.

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

OVERVIEW / PURPOSE OF THE ROLE

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 RESPONSIBILITIES

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.