Quality Assurance Specialist
- Cork
- Contract
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!