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Quality Compliance Specialist – Oral Care
Perrigo Company plcQuality Compliance Specialist ensuring compliance with regulatory standards at Perrigo. Responsible for monitoring product safety and performance in medical devices and pharmaceuticals.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
data analysisstatistical trendingchartinggraphingcomplaint handlingMDR evaluationsCAPA administrationGMP complianceproduct quality improvementproduct failure analysis
Soft Skills
communicationteamworkattention to detailself-motivationproblem-solvingorganizational skillsinterpersonal skillsadaptabilitycritical thinkingcollaboration
Tools & Technologies
Microsoft OfficeExcelTrackWiseQMS documentationGMP floor auditscomplaint reporting systemsinternal audit coordinationexternal audit supportdata visualization toolsstatistical software
Industry Keywords
medical device industrypharmaceutical environmentGMP requirementsCAPAMDRquality management systemcomplianceauditsinspectionsproduct performance issues
About the role
Key responsibilities & impact- Act as a Liaison for the insourced Complaint Handling system.
- Review complaint reports from various sources for different products.
- Support Medical Device Reporting (MDR) evaluations
- Support CAPA administrative activities
- Participate in internal and external audits/inspections, including preparation and on-site support.
- Serve as scribe during external audits
- Assist with coordination of internal audits and GMP floor audits
- Escalate issues to Senior Compliance Specialist or Management
- Support administrative tasks for QMS meetings and documentation
- Follow GMP requirements
- Support continuous improvement initiatives to enhance product quality and compliance.
- Perform basic data analysis, including statistical trending using Excel charts/graphs.
- Learn Perrigo products, becoming knowledgeable on product failure modes and performance issues.
- Identify unique situations, high-risk complaints, or increasing trends and escalate to management.
- Work and communicate with a variety of different functional groups
- Support effective implementation of all GMP requirements and understand how it affects products/processes supported and/or owned.
Requirements
What you’ll need- Bachelor's degree in technical disciplines such as Engineering, or Science preferred.
- Minimum of 1+ years of experience in medical device industry or pharmaceutical environment.
- Proficient in the English language.
- Work well with peers and management in a team environment and as an individual contributor.
- Good verbal and written communication skills.
- Proficient in Microsoft Office and TrackWise
- Ability to perform basic data analysis, charting and graphing in Excel.
- Understand and carry out oral instructions.
- Read, understand, and interpret manuals and written instructions.
- Self-motivated, with excellent attention to detail.
Benefits
Comp & perks- Competitive compensation
- Career development opportunities