Senior QA Specialist

Desired Skills: quality assurance,change controls,CAPA

The role:

PE Global is currently recruiting for a Senior QA Specialist on behalf of a leading pharmaceutical company based in Tipperary. This is an initial 11-month contract role.

Responsibilities:

• As a Senior QA Specialist, you will be a key driver of quality assurance activities at our site, ensuring that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA.
• You will take ownership of maintaining compliance within your assigned areas, working closely with cross-functional teams to uphold the highest standards of quality and regulatory adherence.
• Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and site-specific requirements.
• Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
• Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
• Assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance.
• Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies.
• Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks.
• Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement.

Education and Experience:

• Degree in Science, Quality, or a related Technical field.
• 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
• Strong written and verbal communication skills, capable of clearly articulating complex quality issues.
• Logical thinker with the ability to remain proactive and composed under pressure.
• Proven ability to work effectively both independently and collaboratively within a team.
• Exceptional attention to detail and precision in preparing and reviewing GMP documentation.
• Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***