Sr QA Specialist

Sr QA Specialist

PPD - Pharmaceutical Product Development

Athlone, Ireland

As a Senior Quality Assurance Specialist you will provide comprehensive expertise to the department covering one or more specialized quality management areas, such as GxP manufacturing, quality systems investigations and audits, lab investigations, root cause analysis, or Total Quality Management (TQM), assuring all systems, processes and their outcomes comply with applicable international and national regulations and guidelines and fulfill client and company requirements, and may lead vendor and internal audits, participate in client and regulatory inspections, and/or manage the administration and reporting aspects of quality management systems.

Summarized Purpose:

Provides comprehensive expertise to the department covering one or more specialized quality management areas, such as GxP manufacturing, quality systems investigations and audits, lab investigations, root cause analysis, or Total Quality Management (TQM), assuring all systems, processes and their outcomes comply with applicable international and national regulations and guidelines and fulfill client and company requirements, and may lead vendor and internal audits, participate in client and regulatory inspections, and/or manage the administration and reporting aspects of quality management systems. Serves as quality consultant to the organization in their area(s) of GxP expertise, acting as a resource for training activities and policy-making decisions, supporting business leaders in mitigation of risk, and responsible to build relationships between on-site QA services and QA management of designated clients.

Essential Functions and Other Job Information:

Manages and leads all activities associated with client, regulatory, vendor, quality management system and/or internal audits and investigations to include: coordination, scheduling, hosting, conduction of audits and review of audit responses.

  • Verifies compliance with SOPs/WPDs and contractual obligations for audit target selection and frequency of audits to ensure ongoing quality;
  • Liaises with several internal departments and senior management to provide full internal oversight of the GxP/GDP services provided to clients and facilitate interaction across functional, regulatory and legal teams;
  • Develops, updates and disseminates SOPs/WPDs as they relate to quality processes;
  • Performs internal and external audit related activities as needed and escalates significant issues appropriately. Continually ensures audit readiness of client files;
  • Contributes to quality process improvement activities to ensure the organization meets or exceeds client expectations for the implementation of quality management systems and processes;
  • Ensures full compliance with internal procedures pertaining to quality investigations, quality audits and quality improvement initiatives;
  • Provides mentorship and guidance to less experienced quality staff;
  • Performs root cause analysis. Assists in resolving critical quality issues to include CAPAs, complaints and recalls, and resolves non-critical quality issues such as deviations;
  • Generates reports to provide internal management with tracking, trending, informed analysis reports, process improvement data and key performance metrics.

Education and Experience:

  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification;
  • Relevant quality assurance experience (comparable to 10+ years) including expertise in GxP regulations gained from time served in a pharmaceutical, biotechnology and/or medical device industry.

Knowledge, Skills and Abilities:

  • Comprehensive expertise in all aspects of pharmaceutical GxP regulations (e.g. quality systems, root cause analysis and Total Quality Management) including international regulations;
  • Knowledge of applicable parts of 21 CFR regulations;
  • Knowledge of ISO standards where applicable;
  • Expertise in GxP and appropriate regional clinical research regulations and guidelines;
  • Proven proficiency with leading a range of project based or internal GxP audits and vendor audits to high standards;
  • Superior oral and written communication skills;
  • Expert problem solving, risk assessment and impact analysis abilities;
  • In depth experience in root cause analysis;
  • Excellent negotiation and conflict management skills;
  • Ability to remain flexible, multitask, and prioritize competing demands.

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© EuroJobsites 2019

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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