Science & Pharmaceutical JobsCompliance QA Manager

  • 51095
  • Temporary/Contract
  • Dublin West

Collins McNicholas

As an experienced support resource, your role will have reponsibility for leading continuous improvement initiatives, global quality projects, compliance initiatives, and risk assessments and remediation activities 

QA Compliance Responsibilities

  • Provides inspection readiness support through the identification of compliance gaps and risks, and participation in the remediation process.
  • Provides on-site support during regulatory inspection, as applicable, as Front or Back Room resource and Division scribe.
  • As part of the Global Audit and Compliance team, supports the Compliance Program through the coordination and execution of on-site internal audits and the identification of remediation plans.  
  • Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close.
  • Responsible for communication and documentation of internal and external compliance related information.  Includes changes in regulations, new guidelines and guidance documents from regulatory authorities and trade organizations.
  • Responsible for leading continuous improvement initiatives including creation, scoping and implementation.
  • Manages assigned global quality projects and compliance initiatives.
  • Trains employees on areas of expertise, as requested.

QA Compliance minimum requirements

  • Bachelor Degree or equivalent level of education in a relevant scientific/ technical discipline such as Chemistry, Pharmacy, Biology, Microbiology, Engineering or industry experience with sufficient exposure to pharmaceutical industry
  • 7-10 year experience in pharmaceutical Industry or government regulatory agency and at least 5 years of GxP experience with responsibility for managing the quality system
  • Experience in conducting and handling audits and inspections
  • Strong knowledge of relevant regulations for quality systems and compliance.
  • General knowledge of technical, chemical and pharmaceutical processes, validation procedures and analytical methodology
  • Capable of analysing data in order to support the development of strategies to effectively manage the action plans that will resolve the issues.
  • Excellent verbal and written communication skills and project management skills.
  • Open to International travel up to 40%

option to work 2 days remotely

For a confidential discussion and more information on the role, please contact Tina Egan

tina.egan@collinsmcnicholas.ie

09064 78104

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