MSD Quality Assurance Senior Specialist 

Ireland 

290574562

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

No Travel Required

1st - Day

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