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QA Engineer

 

Reporting to the QA Supervisor, the role of the QA Engineer is to ensure that all site operations are fully in compliance with current international standards for cGMP. This compliance to be maintained with the implementation of effective SOPs and systems, of test methods equipment and processes, cGMP training programs, and effective auditing and self-inspection programs.

PLEASE NOTE THIS IS A FULL-TIME CONTRACT POSITION

 

YOUR ROLE

  • Completion of Customer questionnaires and other miscellaneous queries.
  • Responding to Customer/Regulatory audits and implementing corrective actions
  • Involvement in Customer site audits and preparation of a response to findings along with QA Supervisor/ QA Manager
  • Conducting both Internal and External cGMP audits
  • Lead Quality aspect of new product introduction projects.
  • Participate in Site activities including Process, Cleaning, and Equipment . Assisting in creating process documentation to ensure production processing consistent within validated parameters.
  • Recognize and implement opportunities for continuous improvement.
  • Preparation of Annual Product Reviews.
  • Write risk assessments to assess and identify potential risks associated with various manufacturing and facility activities.
  • Team participant in the review and approval of new suppliers.
  • Review and approval of batch related documentation and final product release.
  • Investigation reporting including Process Deviations, OOS, Material Failures, and Customer Complaints with minimal guidance using root cause methodology. Assist in identifying root causes and coordinate corrective action to quality issues in the facility.
  • Operation and maintenance of the Documentation system including Change Control.
  • Drafting of SOP’s, Monographs, and Master Batch Records.
  • Oversight of Pest Control system.
  • Drive Operational Excellence and Improvement projects related to Quality
  • Develop and maintain metrics systems to provide feedback on Quality performance. Monitor event trends in order to provide proactive corrections/improvement alternatives to minimize the potential for repeat incidents
  • Provision of training/guidance to junior staff.
  • Carrying out all tasks with minimal guidance.

 

WHO YOU ARE

  • Level 8 Degree Qualification –Science / Chemistry discipline
  • Previous experience in QC/ Equipment/Process/Cleaning / Quality role, in a Regulated FDA Environment.
  • Knowledge of Deviation, CAPA, Audit, Change Control, and Customer complaint Trackwise Modules and SAP.
  • Knowledge of 9001:2015
  • Proficient in Microsoft Packages and database systems.
  • Experience in SAP and Trackwise in a Quality Capacity
  • Capable of singular project management
  • Excellent oral and written communication skills.
  • Experience in Regulatory Affairs.
  • Attention to detail and good organisational skills.
  • Mature judgment, problem-solving and decision-making ability. 
  • Ability to operate in a team-based environment and to work on their own initiative where required.
  • Demonstrated knowledge of ICH guidelines
  • Experienced Auditor

 

 

Job Requisition ID:  208241
Location:  Arklow
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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