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Alan O'Riordan
Life Science

+353873657522
[email protected]
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Details

Qualified Person


Reference:AOORASYW-885602 Location: Cork
Cork City
Qualification:MastersExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person

Qualified Person

Location: Cork, Ireland
Relocation: No

Job Description Summary

As the Qualified Person, you will manage and drive the site QA systems in close cooperation with other specialists in the QA Product Quality Team. You will coordinate and execute all QA duties relating to QP batch release and communicate all issues.

Job Description Responsibilities
• Coordination of the certification of finished product batches to the market as required under the EU directive 2001/83/EC
• Ensure that the batch and its manufacture comply with GDP, GMP, Regulatory Licences and Marketing Authorization
• Maintain oversight of deviations, CAPA & Change Controls and ensure any issues which have a regulatory impact are notified to health authorities and mitigated as required
• Continuous improvement of the manufacturing and quality systems – Identifying and building in efficiencies as necessary from a systematic and compliance perspective
• Coordinate support for operations in general troubleshooting and problem solving, providing technical direction and guidance to support overall business needs
• Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice.

Qualifications and experience

• Eligible to act as a Qualified Person in line with local and EU directives.
• 3rd level qualification in Science / Engineering discipline
• Significant experience within a GMP / QA environment in a pharmaceutical company or similar regulated environment

Desired Skills
• Ability to create and maintain effective interpersonal relationships with all levels of personnel within all cross functional departments in the organization
• Excellent communication, negotiation and risk based decision making skills, promoting openness, dialogue and collaboration
• Results oriented with a strong ability to effectively troubleshoot and problem solve issues
• Promote a continuous improvement culture.

Eligibility requirements: A good level of English and a valid work permit (Stamp 4/ EU Citizenship)

For further information, contact Alan on [email protected] or via phone at 087 365 7522