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  • DUBLIN 2
  • Job reference number:15358873
  • Client ID:RI/AM16451
  • Posted on:14-JUN-2018
  • Location:WICKLOW
  • Job type:PERMANENT

Quality Engineer (pharma) - County Wicklow.

The ideal candidate will have a science related background with a solid understanding of cGMP guidelines as they pertain to API pharmaceutical manufacturing, with an emphasis on quality standards, compliance, facility, equipment and process qualification activities.

You will be responsible for providing quality oversight, managing the technical quality aspects associated with the manufacture of API's and other materials. Areas of emphasis include but are not limited to implementing ISO9001:2015, Trackwise, supporting customer audits, risk management, process validation and capability assessments, periodic review of validated systems, trend analysis of data and completion of annual product quality reviews.

Essential Duties and responsibilities of this position include but are not limited to:

• Design and execute Quality related protocols; and summarise studies to ensure consistency of data and compliance with manufacturer and customer specifications and with current Good Manufacturing Practices.
• Investigation reporting for Process Deviations, OOS, Material Failures and Customer Complaints with minimal guidance using root cause methodology.
• Assist in identifying root causes and co-ordinate corrective action to quality issues in the facility.
• Compile and interpret quality data, monitor event trends in order to provide proactive corrections/improvement alternatives to minimise the potential for repeat incidents.
• Act as technical liaison, as needed, between process technology, manufacturing, external manufacturers & suppliers.
• Write risk assessments to assess and identify potential risks associated with various manufacturing and facility activities and identify appropriate mitigation plans.
• Drive operational excellence and improvement projects related to Quality. Recognise and implement opportunities for continuous improvement.
• Participate in Site Validation activities including Process, Cleaning and Equipment validation. Assisting in creating process documentation to ensure production processing consistent within validated parameters.
• Capable of singular project management (within the realm of Quality Engineering) for smaller scope Quality Engineering Plans.
• Preparation of Annual Product Reviews in line with annual schedule.
• Issues data, memos, presentations and reports concerning Quality projects or areas of interest.
• Lead Quality aspects and support new product introductions and assist in ensuring product development activities have all necessary Quality Engineering supporting justification.
• Completion of Customer questionnaires and other miscellaneous queries.
• Supports Audits: Hosting and preparation of responses and implementing corrective actions along with QA Supervisor/ QA Manager
• Conducting both Internal and External cGMP audits
• Team participant in the review and approval of new suppliers.
• Review and approval of batch related documentation and final product release.
• Operation and maintenance of the Documentation system including Change Control.
• Drafting of SOP’s, Monographs and Master Batch Records.
• Develop and maintain metrics systems to provide feedback on Quality performance.
• Provision of training/guidance to junior staff.
• Carrying out all tasks with minimal guidance.

Qualifications and experience required:

• Degree Qualification –Science / Chemistry discipline or equivalent experience with relevant regulatory experience.

At least 2 years' pharmaceutical, laboratory, manufacturing or Quality Engineering related experience in a regulated FDA environment.

• Previous experience in Biopharmaceutical manufacturing facility & quality systems an advantage.
• Thorough knowledge of cGMP's and SOP's related to Quality.
• Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ISO standards, ASTM standards, etc.
• Excellent knowledge/understanding of protocol acceptance criteria and capable of determining appropriate Corrective action/Preventative Action (CAPA).
• ASQ Certified Quality Engineer, Six Sigma training and Lean Manufacturing training desirable

This job originally appeared on RecruitIreland.com