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Principal Auditor (LOA006973)

Reference:A006973
Location: Dublin
Qualification:Degree
Experience:10+ Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Quality Auditor

Responsibilities

  • Manages the auditing metrics program which involves tracking audit responses and auditee’s CAPAs until completion and closeout.
  • Manages audit activities which include audit agendas, audit reports and communicates finding to external and internal stakeholders.
  • Performs evaluations of quality systems and practices to identify potential problems such as non-conformance to applicable SOPs and quality standards (GMP, ICH, ISO, IPEC, etc.), coordinates resolutions, and provides guidance on quality/compliance risk levels.
  • Supports the audit program by independently conducting internal and external audits or participating as an audit team member.
  • Contributes to the development of the annual audit plans and schedules.
  • Collects, collates and evaluates applicable key auditing performance parameters for metrics report generation and presentation to management and stakeholders.


As related to Enterprise Quality Auditing Functions:

  • Responsible for the development and implementation of EQA programs, policies, procedures, agreements & controls.
  • Leads Mock PAIs of CMOs to prepare the facilities for audits and assess gaps in the system.
  • Organizes and leads periodic audit review meetings.
  • Provides guidance for continuous improvement to ensure compliance with regulations and current industry standards.
  • Evaluates metrics to determine trends and opportunities for continuous improvements.
    Assists in FDA inspections and may interact with regulatory authorities during regulatory inspections.

Qualifications:

  • Minimum of a BA/BS with a minimum of 10 years’ experience in a pharmaceutical manufacturing or Quality Assurance/Compliance environment.
  • ASQ-CQA or ASQ-CQE certified highly desired.
  • Possesses strong technical and quality/compliance background related to pharmaceuticals/biologics.
  • Possesses thorough knowledge of current domestic and international standards and regulations related to pharmaceutical dosage forms/devices, (e.g., cGMP, GLP, ICH guidelines and guidance documents) and how to apply them to products pending release, and marketed products.
  • Has extensive experience and technical expertise in over 10 audit areas, such as API, Micro Lab, sterile drug product, Contract Pkg., Mock PAI, etc.
  • Demonstrates the ability to review investigations, change control, analytical data, test reports, batch records and certificates of analysis and other technical documents
  • Demonstrates the ability to conduct GMP audits of drug product and/or medical device manufacturers, as well as manufacturers of chemical raw materials and packaging components.
  • Demonstrates the ability to conduct focused quality incident investigations.
  • Able to use Word, Excel, Power Point and Outlook.
  • Excellent communication skills, both written and verbal.
  • International Travel


If you would like further Information you can contact the recruiter directly:

Libby Ryan | Tel: +353 (0) 1 507 9254




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