QA Operations Specialist

ref. 01244

QA Operations Specialist

Fantastic opportunity for a QA Operations Specialist to join our client, a leading Pharmaceutical company located just outside of Dublin.

Role

The QA Operations Specialist will lead Quality Assurance, being a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations.

Primary responsibilities involve maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations and provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required.

The ideal candidate will have fulfilled the educational requirements for this role and have the necessary experience within an FDA/EMEA regulated environment.

Responsibilities

1. Lead, facilitate and participate daily on cross-functional teams to collaboratively address compliance issues and achieve project milestones.
2. Participate in investigations and risk assessments related to deviations/complaints and changes, ensuring appropriate actions are implemented timely.
3. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements at the facility.
4. Complete QA operational duties related to product disposition including in-coming material release and the performance of detailed review of eBR prior to QP release.
5. Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.
6. Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
7. Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required.
8. Assist in the creation and maintenance of QA policies, SOPs and reports in line with site requirements.
9. Participate in and support risk management activities in line with relevant guidance and best industry practice.
10. Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
11. Ensure the escalation of compliance risks to management in a timely manner.
12. Assist in the execution of the internal audit programme including the performance of audits as required.
13. Work collaboratively to promote strong relationships with management and colleagues while driving a safe and compliant culture.

Requirements

1. A Degree qualification (Science/Quality/Technical).
2. 8-10 years of experience, ideally in Quality Assurance, Technical Operations or Quality Control within the Biological and/or pharmaceutical industry.
3. Project Manager capability with strong understanding of Operations.
4. Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
5. Strong written and verbal communication skills.
6. Experience in quality management systems such as Veeva, SAP, PAS-X etc.
7. Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
8. Strong attention to detail and accuracy in preparing and reviewing GMP documentation.
9. Experience in direct interactions with regulatory authorities during site inspections.

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