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Quality Specialist, Cork City



Cork City, Ireland 

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€50,000.00 - €55,000.00

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Job Description:


* 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 complaints and adverse drug event in line with agreement contacts.
* 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.
* Review, approve quality records (change controls, deviations, CAPAs, procedures, validation, and other quality related documents. Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections.
* 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.
* Maintain a good understanding of existing and emerging pharmaceutical regulations and evaluate the impact on the private label business.
* 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.
* Provide day-to-day department support activities as necessary to aide completion of project deliverables.
* Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required and cross training as required.


* Educated to degree level, ideally B.Sc. in Chemistry, Microbiology or other scientific discipline.
* 5+ years pharmaceutical experience in a progressive multinational organization. Minimum 3 years in a Quality Assurance role.

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com.

If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O’Connell on + 353 86 126 3871 or send your CV to doconnell@berkley-group.com
Company Info
Berkley Recruitment Group

Cork, Ireland

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