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Compliance Specialist – Technical Operations

  1. West
  1. Contract
Competitive
  1. Compliance / Quality Assurance
14-09-2023
32174
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Compliance Specialist - Technical Operations - Life Science - Limerick 

Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client’s side for a global Pharmaceutical organisation on a major expansion project based in the picturesque Munster region of Ireland. 

Located just 20 minutes from the nearest international airport, the manufacturing site is workable for those wishing to commute to/from Ireland for a contract position. You will be required on site for 5 days per week Monday – Friday working 45 hours.

Role Summary:
  • Completes investigations of technical deviations for department issues of noncompliance.
  • Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness. 
  • Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support.
  • Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/prevention action plans.
  • Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documentation, etc. to assess for compliance with established quality standards, policies, and procedures. 
  • Completes investigations of technical deviations for department issues of noncompliance.
  • Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
  • Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support.
  • Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/prevention action plans.
  • Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documentation, etc. to assess for compliance with established quality standards, policies, and procedures.
Requirements: 
  • Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
  • Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
  • Strong interpersonal, written, presentation, communication, and investigation skills with the ability to engage with a diverse range of individuals across all levels of the organisation.
If this role is of interest to you, please apply now for immediate response! 

The candidate must have the rights to work in the location stated in the job advert.

Please note, Quanta part of QCS Staffing does not sponsor Visa applications.

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