Quality Assurance Specialist

Job Title: QA Specialist - Packaging and Labelling Operations (12-month Contract)

Location: Cork, Ireland

Company Overview: Join a leading biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines that address unmet medical needs. Our focus areas include HIV/AIDS, liver diseases, cancer, inflammation, and serious respiratory and cardiovascular conditions. We are committed to improving the care of patients living with life-threatening diseases worldwide.

Job Description: We are seeking a QA Specialist to support our Packaging and Labelling Operations on a 12-month contract. The successful candidate will join our QA Department, focusing on the QA packaging and labelling support team. This role requires a proactive individual with a sound knowledge of quality assurance systems, methods, and procedures.

Key Responsibilities:

• Ensure compliance with applicable cGxP regulatory requirements.
• Develop and review Standard Operating Procedures (SOPs) and other controlled documents.
• Perform QA review and release of primary and secondary packaging components.
• Conduct QA review and approval of artwork.
• Identify deviations from accepted practices, evaluate impacts, and determine appropriate actions.
• Review and approve GMP Deviation investigations and CAPAs.
• Review and approve Master data and recipes required for operations.
• Participate in data gathering exercises to develop and maintain QA metrics.
• Engage in compliance improvement projects, and represent QA in cross-functional meetings.
• Assist with compliance audits and walkthroughs to ensure site compliance with GMP.
• Work with secondary packaging contract organizations, reviewing and approving related documents.

Qualifications:

• Prior experience in the pharmaceutical industry, ideally within a QA role.
• Demonstrated knowledge of current Good Manufacturing Practices (cGMPs) and FDA/EMEA standards.
• Proficiency in applying QA principles, industry practices, and standards.
• Basic knowledge of OPEX Lean tools and root cause analysis.
• Strong audit, investigation, and report writing skills.
• Excellent verbal, technical writing, and interpersonal skills.
• Proficiency in Microsoft Office applications.

Education and Experience:

• 4+ years of relevant experience in a GMP environment with a BS degree, or
• 3+ years of relevant experience with a MS degree.
• Pharmaceutical industry experience is preferred.

Behaviors:

• Positive attitude and enjoys working as part of a team.
• Resilient with the ability to deliver in a challenging environment.
• Ability to engage and manage multiple stakeholders to achieve objectives.
• Curious with a strong learning agility.
• Operationally excellent and organized with a systematic approach to prioritization.
• Process-oriented to achieve business objectives.

Core Values:

• Integrity: Always doing the right thing.
• Teamwork: Collaborating in good faith.
• Excellence: Working with a high level of commitment and capability.
• Accountability: Taking personal responsibility.
• Inclusion: Encouraging diversity.

How to Apply: If you are interested in this opportunity, please apply below or message me directly at clandy@i-pharmconsulting.com!