LSC have a great contract opportunity for a CQV QA Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide QA Oversight: Ensure all CQV activities meet GMP and regulatory standards.
- Review CQV Documents: Approve qualification protocols, reports, and risk assessments.
- Support Equipment Qualification: Oversee qualification of analytical instruments
- Manage Quality Events: Review and resolve deviations, change controls, and CAPAs.
- Ensure Compliance: Monitor adherence to FDA, EMA, and internal quality procedures.
- Conduct Risk Assessments: Identify and address risks related to systems and processes.
- Support Documentation Control: Maintain timely QA review of all GMP-related documents.
- Collaborate with Teams: Work cross-functionally to support validation strategies and timelines.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BSc in Science or Engineering
- At least 5 years of relevant experience in the pharmaceutical industry in a similar or related role.
- Strong understanding of GMP and validation principles.
- Familiarity with relevant software packages, such as KNEAT and VAULT Quality.
For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available at this time. Thank you for your attention.
Apply via this advert or contact Gráinne Hodnett at LSC on 021-4777329 if you have any more questions about this.
