Senior QA Specialist

Senior QA Specialist

Zoetis

Tullamore, Ireland

Role Purpose

The Senior QA Specialist will play an active role in support of the general site quality system. In addition, take an active role in internal and external audits, outsourced activities, batch review and release, analytical data review and interface with cross functional departments on quality matters.

The Senior QA Specialist will support the ongoing maintenance and continuous improvement of existing QA process and SOPs across all disciplines.

Reporting Structure

  • Reporting to the Quality Operations Manager.

Duties & Responsibilities

  • Review & approval of batch records for Cell Culture operations and Purification operations to ensure compliance with the requirements of cGMP and batch review and batch disposition process. Compilation of all required documents for QP release. SAP Batch review transactions;
  • Review and approval of production and QC raw data at source;
  • Support change management, deviations and CAPA systems as required;
  • Review and approval of non-conformance reports including deviations, laboratory investigations & environmental excursions;
  • Partake in or lead Internal and External audit program including 3rd party audits and supplier reviews;
  • Support the ongoing site training system and deliver training modules where required;
  • Partake in the vendor management process to include vendor assessments, auditing and qualification and supplier change notification. Oversee and support site Material requirement specifications;
  • Prepare Quality agreements with required Vendors;
  • QA oversight of site gowning programmes;
  • Support ongoing running and maintenance of Electronic Quality Management System;
  • Participate in ongoing site data integrity projects;
  • Support site risk management procedures;
  • Overview product and cell bank stability programmes, submission of samples, filing of results and providing updates;
  • Manage specific projects that may arise, in a timely and efficient manner.

POSITION SPECIFICATION

Qualifications, Experience, Skills, Knowledge and Attributes

  • Third level Degree in a life science discipline;
  • At least 5-7 years Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP;
  • Good knowledge of regulatory and cGMP guidelines and directives, including product certification, validation, quality control and manufacture including QbD and Risk Management;
  • Experience of interaction with cross-departmental teams;
  • Excellent interpersonal and communication skills, meticulous eye for detail;
  • Self-motivation;
  • Computer literate;
  • Strong time management awareness and the ability to drive projects forward.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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