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MSD Quality Assurance Senior Specialist Ireland 290574562
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Job Description
What you will do:
Bring energy, knowledge, innovation and influence to carry out the following:
Responsible for oversight of site deviations (investigations and incidents), collaborating with cross-functional teams, including but not limited to Quality Control, Warehouse, QA Operations, technical and manufacturing to effectively investigate site deviations and ensure alignment with quality and regulatory expectations.
Lead and support site deviation investigations to identify root causes, assess impact, and implement corrective and preventive actions (CAPAs).
Ensure timely documentation and resolution of deviations in accordance with topic 3.5 Deviation Management and regulatory requirements.
Lead, coach, support and develop site investigators who are proficient in root cause analysis tools and technical writing.
Collaborate with Topic 3.5 Deviation Management and 3.8 CAPA Topic Lead to ensure compliance to our company standards and relevant regulatory requirements.
Drive compliance with site and global deviation metrics.
Managing the escalation/update to Site Leadership of more significant investigations.
Coach and support investigators during site global & regulatory inspections and provide support to the Internal Audit Program on site.
Developing and implementing a robust strategy for the investigation of major site events
Provide subject matter expertise in root cause analysis and technical writing to drive best practices and maintain right first time.
Engage with the appropriate organizations centres of excellence (CoE) and with external partners to ensure the very best of processes are brought to Dunboyne.
What skills you will need:
In order to excel in this role, you will more than likely have
Minimum degree or post-graduate qualification (Science/ Pharmacy/ Engineering).
At least 6 years’ experience in the pharmaceutical industry (preferably experience in Biologics)
Understanding and practical application of GMP standardsandregulations
Working knowledge of Deviation Management regulations and best practices
Excellent communication and interpersonal skills, with the ability to collaborate effectively at all levels of the organization and with external partners.
Proven record of influencing change
Skilled supporting cross-functional investigations with a high standard of technical writing.
Analytical problem-solving skills
So, if you are ready to:
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
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