Qualified Person Needed in Northern Ireland

We are currently looking for a Qualified Person (QP) to join a pharmaceutical company based in Northern Ireland.

Salary & Benefits

• £77,000 per annum
• Comprehensive benefits package offered

The Role

• Operate within the Code of Practice for Qualified Persons in the pharmaceutical industry as relevant to the manufacture of clinical trial materials and licensed materials, as appropriate.
• Remain current with country specific requirements and clinical trial legislation relating to the business, offering expert advice in a consultancy role as the need presents itself.
• Remain familiar with the structure and content of a Clinical Trial Application, the most commonly occurring issues and be able to offer customers guidance on best practice.
• Determine the requirements for, and level of release necessary for materials handled at the facility, including the release of just-in-time labelled material for dispatch.
• Evaluate study supply chains and assess, as applicable.
• Audit manufacturing and testing sites. Compile audit reports to a high standard in accordance with the relevant procedure.
• Review QP Study Files as new releases are scheduled and become familiar with the specifics of the Clinical Trial.
• Review study and lot specific documentation necessary to facilitate QP Release. Use technical knowledge to assess the criticality of any issues. Confirm compliance with the Clinical Trial Application.
• Assess stability data in light of pending expiry updates.
• Ascertain the status of the Clinical Trial Application in each participating country prior to release, considering the impact of substantial amendments or notifications to the Clinical Trial Application.
• Perform QP Release in accordance with the schedule. Proactively highlight matters and interdependencies that could impact on release timelines, ensuring the customer and project staff are kept informed. Assess the impact of such and provide advice on avoidance strategies.
• Fulfil any necessary administrative duties required with QP activities.
• Ensure all customer contact, oral and written, is carried out professionally in order to develop and maintain good working relationships with each customer (both internally and externally).
• Receive and follow through on all customer queries received, ensuring a response is supplied in a timely manner.
• Escalate any customer complaints in accordance with the relevant procedure.
• Co-ordinate/attend internal/external teleconferences/meetings, initiating Qualified Person related discussions for new or ongoing business, as required.
• Represent the Quality Compliance aspects of the business during customer audits and sales visits, promoting Clinical Services expertise in Qualified Person related activities, in the generation of new or on-going business.

Requirements

• Honours Degree in Biology, Pharmacy, Chemistry or related subject
• Experience in undertaking the routine duties of a Qualified Person
• Experience in a Quality related role within the pharmaceutical industry
• Experience in more than one dosage form
• Experience in Biological Drug Products
• Experience in auditing suppliers, API facilities, drug product manufacturing or testing sites
• Experience working in a contract manufacturing arena
• Knowledge of Clinical Trials Legislation

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