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Senior QC Associate

Job description

Senior Compliance Analyst

Work within a growing biologics unit for a world leading pharmaceutical company. In association with the associate director and Snr manager the Compliance analyst will work to meet company goals and objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and regional Ministries of Health. This position will support and manage the following:

  • Deviation management
  • Change Control Program
  • Inspection Management: (Coordinate site GMP inspections; Internal site preparation; pre-audit MOH requests; Response/report compilation & issuance; Post audit commitment management); 
  • Quality metrics & monthly quality system & Senior Management review meetings; (Meeting preparation and coordination of post meeting commitments
  • Manage regulatory standard/guidance revision assessments
  • Coordinate the site quality plan and ensure plan execution
  • Manage compliance initiatives program
  • Management of site quality risk management program: (Management of the site QRM improvement plan. Attend risk assessment meetings)

 

Responsibilities:

  • You will maintain strong relationships with management to develop the Compliance and Quality Assurance function.
  • You will work with senior management to assess implications of new regulatory requirements and ensure effective analysis of quality KPIs and protocols.
  • Support the Quality Program and Regulatory Audits.
  • Oversee change controls and new product introductions from a compliance perspective.
  • Coordinate site quality monthly meetings for assessment of quality system performance.
  • Management of vendor audit program
  • Review and approval of Trackwise records and associated documentation 

 

Requirements:

  • 3rd level degree in Science or Engineering with 4 years or more experience within a Pharmaceutical or similar environment.

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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