Senior Quality Systems and Compliance Specialist
Reference: | AMC21217 |
Location: |
Meath
|
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
Quality Systems and Compliance Specialist (Senior)
AMC21217
Contract – 6 months
Co. Meath
We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Co. Meath. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Join the dynamic team at the Research & Development Division facility as a vital member of the Global Development Quality Assurance team. In this role, you'll play a pivotal part in ensuring the highest standards of quality and compliance across our operations.
Key Responsibilities:
- Collaborate daily with cross-functional teams to address compliance issues and meet project milestones effectively.
- Lead and participate in investigations of deviations, risk assessments, and changes, ensuring timely implementation of appropriate actions.
- Review and approve Change Controls, Deviations/CAPAs, SOPs, and related documentation for compliance with GMP and site requirements.
- Provide oversight to GMP readiness, technical transfers, regulatory approvals, and clinical operations.
- Contribute to the development of training materials and provide subject matter expertise (SME) training on Quality Assurance SOPs as needed.
- Assist in the creation and maintenance of QA SOPs, metrics, and reports to meet site requirements.
- Identify and implement efficiencies and quality improvements to foster a culture of continuous improvement.
- Foster strong relationships with management and colleagues to promote a safe and compliant environment.
- Ensure timely escalation of compliance risks to management.
Required Skills:
- Bachelor’s degree or higher in Science, Quality, or a related field.
- 4-5 years of experience in Quality Assurance, Quality Control, or Technical Operations in the biological and/or pharmaceutical industry.
- Proficiency in QRM, SQM, Deviations, and Change Control processes, with experience in investigations and problem-solving.
- Strong attention to detail and precision in preparing and reviewing GMP documentation.
- Excellent written and verbal communication skills.
- Ability to think logically and be proactive in a startup environment.
- Team player with the ability to work independently.
- Familiarity with quality management systems such as Veeva, SAP, PAS-X, Delta V, Trackwise, etc.
- Knowledge of FDA, HPRA, EMEA, and other regulatory requirements related to Biologics and/or Pharmaceuticals.
Desirable Skills:
- Experience in direct interactions with regulatory agencies during site inspections.
- Previous experience in a sterile/low bioburden environment.
If you're passionate about quality and compliance and thrive in a collaborative, fast-paced environment, we'd love to hear from you! Please feel free to contact Angela McCauley on +353 (0)87 693 0951 or angela.mccauley@lifescience.ie for further information.