MSD Lab Operation - Compliance Specialist 

Ireland, Cork 

913315018

Job Description

Bring energy, knowledge, innovation to carry out the following:

• Supports the Lab Operations Compliance Plan and Quality Metrics generation.
• Complete review and approval of Lab Operations documentation.
• Leads walk-down and support Audits.
• Participate in the preparation for and hosting of regulatory Internal, and Customer Audits.
• Investigation of Quality Notifications.
• Provide Compliance guidance to Operating procedure.
• Review Deviation trends and identify effective CAPA’s where necessary.
• Member of the Site PIR, working with Lab Operations IPT to ensure that the department is Permanently Inspection Ready.
• Proactive monitoring of CAPAs to ensure holistic trends are proactively resolved.
• Participates in the overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA.
• Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
• Partner with cross functional groups to support change management to implement process improvements.
• Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, regulatory inspections and incident investigations.
• Consistently deliver on specific area Key Performance Indicators (KPIs), e.g. EHS metrics, production plan, compliance and team training

Ensure highest Quality & Compliance standards. kills you will need:

In order to excel in this role, you will more than likely have:

• Third-level Qualification in a Science or Engineering related subject.
• 5+ years’ experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience.
• Demonstrated technical knowledge and experience in compliance (GMP, Engineering and Technical).
• Excellent communication, decision making, people influencing and project management skills.
• Relevant GMP standards.
• Quality System.
• Understands key business drivers and uses this knowledge to make decisions and prioritize.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

Not Applicable

*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.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.