Senior QA Specialist

Co Tipperary
Contract
Full-time

1 day ago

ref. 01208Senior QA SpecialistAsset Recruitment is seeking a Senior QA Specialist for a contract position, on behalf of our client, a global pharmaceutical company based in Co. Tipperary. The successful candidate will play a central role in Quality Assurance activities at the site, guaranteeing that all operations are aligned with cGMP requirements from authorities such as the FDA and EMEA. In this role, you will take ownership of maintaining compliance within their assigned areas, collaborating with cross-functional teams to uphold the highest levels of quality and regulatory compliance.This role will initially require the person to be onsite for training. Once the training is completed, it will transition to a hybrid arrangement, with one day per week working from home.Key Responsibilities include:

Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and site-specific specifications.
Supervise and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and guiding necessary updates.
Oversee Quality Assurance operational duties related to product disposition, ensuring timely and compliant decision-making.
Participate and execute internal audit program, including conducting audits as required to ensure ongoing compliance and improvement.
Support in implement and maintaining QA policies, SOPs, and reports that support site operations and compliance.

Requirements:

5-10 years’ experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
A Degree in Science, Quality, or a related technical field.
Pharma experience required
Excellent written and verbal communication skills.
Analytical thinker with demonstrated ability to remain proactive under pressure.
Excellent attention to detail and accuracy in creating and reviewing GMP documentation.
Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar
Strong communication and organizational skills.

Asset Recruitment

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