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Product Quality Specialist - Pharma

Job Seekers Ireland Engineering, Science Pharmaceutical

Job Summary

  • Cork
  • Permanent
  • BBBH781799
  • May 07, 2021
  • Competitive
Job Description

An excellent office based Quality Assurance role with a leading Global business, perfect for someone who has strong systems experience and are comfortable working with International teams

This is an excellent permanent role within a multi-national pharmaceutical company where you will have the opportunity to work in an office setting and away from the manufacturing floor. This opportunity will allow you to join an engaging and inclusive team where 'one team one dream' really means something. This role will give the successful individual the opportunity to build and maintain new relationships with customers, regulatory bodies and suppliers.

This role will support the US side of the business. The post holder will be responsible for ensuring that licensed pharmaceutical products are manufactured and tested in compliance with cGMPs, US FDA and other applicable regulations. The individual will support in the monitoring of multiple global contract manufacturer sites, review and product and batch records, analyse and trend data, generate metrics and prepare reports for the Quality department and management and ensure product issues are escalated and resolved.

Someone who has strong systems experience and who has experience working with international teams would work well within this environment.

KEY RESPONSIBILITIES

  • Review documentation for all batches and shipments of product to ensure compliance to quality standards prior to shipping and distribution.
  • Support the introduction of New Products into the business from contract manufacturers
  • Prepare metrics to monitor and cross-compare the quality systems of contract manufacturers.
  • Review and assess deviations, change controls, product complaints, Investigation reports and assigned CAPA's from CMOs and follow up with contract manufacturers as needed to ensure effective understanding and resolution
  • Review Process validation and annual product reviews for products from contract manufacturers to ensure products are validated and remain validated
  • Assist in ensuring Product Quality policies are conducted correctly and efficiently
  • Assist in Quality internal and external audits as required.
  • 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.

REQUIREMENTS

Education & Experience:

  • Educated to degree level, ideally B.Sc. in Chemistry, Microbiology or other scientific discipline.
  • 4+ years pharmaceutical experience in a progressive multinational organisation. Ideally the post holder will have manufacturing, technical or laboratory experience.

Knowledge and Skills:

  • Solid understanding and knowledge of cGMP and regulatory principles in a pharmaceutical manufacturing environment.
  • Ability to work independently and make decisions based on judgement and integrity.
  • Proven analytical skills and ability to transfer findings into report and presentation formats.
  • Ability to work effectively with others to accomplish goals in a challenging environment.
  • Excellent communication skills with ability to communicate at all levels within the organisation.

If you feel you would be a fit, or would like to find out more about this role, click the 'apply now' button or reach out to Kellie on 021 2300 300 or kodonovan@morganmckinley.com today

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

kellie-o-donovan
Kellie O'Donovan
  • Senior Consultant | Engineering Recruitment - Quality & Validation
  • 353 (0) 21 2300300
  • kodonovan@morganmckinley.com