Job Detail

Location Sligo
Salary Negotiable
Posted
Role Type Fixed Term Contract
Contact Clara Burke
email science@hero.ie

Senior Compliance Specialist

Senior Compliance Specialist



My client a leading pharmaceutical company in Sligo is looking to hire a Senior Compliance Specialist on a one-year fixed-term contract basis.

As the Senior Compliance Specialist, you will be responsible for developing, managing, and documenting Quality Systems to ensures full compliance with all applicable regulatory and requirements.

Key Responsibilities include:

  • Coordinate the development and maintenance of the company’s quality system in compliance with all applicable regulatory requirements and to ensure that products manufactured meet the requirements of end-users, of regulatory authorities and the company
  • Lead and guide team members including Compliance Specialists, Documentation Controllers and QA Administration Controllers
  • Develop and coordinate the Quality System, ensuring full compliance by all personnel with its requirements
  • Ensure Quality Systems Manager and QA Director is kept informed of system failures to ensure corrective/ preventive action is undertaken where required
  • Take ownership of performance measurements of the Quality System providing reports at management review, during quality performance meetings and all other required reviews
  • Preparation of plant Site Master File and Product Quality Reviews
  • Assisting in the investigation of and coordinating customer complaints/exceptions by ensuring the implementation of effective corrective/preventive action where necessary
  • Supplier evaluation and approval of maintenance and technical agreements
  • Coordinating and management of change control programs and ensuring compliance reviews on change requests are performed on non-manufacturing related changes
  • Support the Quality Systems Manager and QA Director in Inspection readiness programs
  • Work closely with the International Quality Assurance, FDA, IMB and other regulatory bodies
  • Establishing the Corrective / Preventive Action system and procedures
  • Verification of effectiveness of corrective/preventive actions arising out of product, vendor evaluation and approval
  • Working with QA Director, Compliance and MQA group to ensure we meet the customer, quality, service, regulatory and financial goals
  • Identifying any causes of non-compliance of the quality system while maintaining effective communication with all employees within the plant and external auditors
  • Adhere to and supports all EHS & E standards, procedures, and policies

Education and experience required:

  • A third level qualification in a science, quality or relevant discipline
  • At least 4 years’ experience in a similar position
  • Strong knowledge of regulatory requirements
  • Quality systems experience and familiar with vendor evaluation, qualification, coordination of change management process etc.
  • Strong communication skills both verbal and written

For further information on this Senior Compliance Specialist role in Galway please contact Clara Burke on 086 8168273 / science@hero.ie


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Clara Burke

JOB-11388

Senior Compliance Specialist

Clara Burke

Role Type Fixed Term Contract
Contact Clara Burke
email science@hero.ie
mobile +353 86 816 82 73
linkedIn profile click here

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