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Barden are delighted to be supporting our rapidly expanding Global Pharmaceutical and Healthcare client in their search for a Quality Specialist. The Quality Specialist will assist the Quality Compliance Manager in the daily management of quality events including the analysis of post marketing activity arising from product complaints and queries.
This is an initial 12 month fixed term contract.
Roles & Responsibilities:
- Review, approve quality records (change controls, deviations, CAPAs, procedures, validation and other quality related documents.
- Ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections.
- Daily operation of the product complaint and medical enquiry process.
- Ensure all complaints are logged, assessed for regulatory reporting requirements, investigated and closed in a timely manner.
- Complete monthly reconciliation of complaints.
- Support and participate where required in the submission of product field alert and other safety reporting.
- Maintain a database of product information to ensure that the third service providers have the information they need to respond to customers queries and circulate product complaint and adverse drug event in line with agreement contacts.
- Analyse and trend data, generate metrics and prepare reports for the Quality department and management, escalate any product, supplier or system issues found, tracking to resolution.
- Drive continuous improvement of processes to ensure quality is maintained while efficiency is optimized.
- Participate in regular team and group meetings ensuring to keep the management team updated on issues and actions which impact the business.
- Support cross-training opportunities and skills.
ABOUT THE PERSON:
Education & Work Experience:
- Bachelor’s degree required.
- 5 years GMP experience
- 3 years QA experience
Qualifications/Skills and Knowledge Requirements:
- Experience in recording and handling of customer complaint and queries. Along with working knowledge of complaint related risk assessments and FAR’s3
- Experience in acting as Quality approver of Quality events (change controls, CAPA’s and Deviations)
Hi, we’re Barden. We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Legal, Life Sciences, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions. Simple.
