Quality Auditor

PE Global; Tipperary; On-site; EUR 65,000 - 90,000; Full time

Job summary

PE Global is recruiting a Quality Auditor for a leading pharmaceutical company in Tipperary, Ireland. This 11‑month contract sits within Global Development Quality (GDQ) and supports GMP QA activities related to the GDQ IMP Licence at the site.

You will audit data, methods, facilities and systems, review release documentation, and help drive continuous improvement through CAPA, deviations and change controls.

Qualifications

• Degree in Engineering, Science, Quality, or a related Technical field.
• 4+ years of experience in Quality Assurance within FDA/EMEA regulated environments.
• Strong quality auditing experience.
• Strong written and verbal communication skills.
• Logical thinker with the ability to remain proactive under pressure.
• Proven ability to work independently and collaboratively within a team.
• Exceptional attention to detail and precision in GMP documentation.

Responsibilities

• Completes audits of data, information, procedures, facilities, equipment and systems (incl. computer systems) to ensure compliance to SOPs, GMPs and regulations.
• Review and approve production and analytical documentation for release of drug substances, products and packaged finished goods.
• Communicate and collaborate with cross-functional areas to resolve audit comments and issues.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and recommend continuous improvement.

Skills

Quality auditing

Auditing experience

Communication skills

Attention to detail

Education

Engineering/Science/Quality degree

Job description

The role:

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

Description:

The Contractor is a member of a team within Global Development Quality (GDQ) and is involved in supporting the GMP Quality Assurance activities for the GDQ IMP Licence at the site.

Responsibilities:

• Completes audits of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to SOPs, GMPs and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement
• Creates and maintains assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPA’s.
• May assist in the induction process for new starters.
• Generally follows standard procedures and consults with manager/supervisor on exceptions.
• Compiles data for reports and presentations - May interpret data and draw conclusions.
• Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
• Keep abreast of cGMP requirements as described in applicable worldwide regulations.
• Additional activities may be assigned by the manager/supervisor

Education and Experience:

• Degree in an Engineering, Science, Quality, or a related Technical field.
• 4+ years of experience in Quality Assurance within FDA/EMEA regulated environments.
• Strong quality auditing experience
• 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.

Eligibility:

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