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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Quality Compliance Specialist


Reference:SCAWCL-608433 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Quality Compliance Specialist
Our pharmaceutical client are expanding their team and are currently recruting for a Quality Compliance Specialist to join them on a permanent basis.

Responsibilies

  • Assist with the QMS System set up for GDP
  • Maintaining the Change Control system, Deviations, CAPA and Complaints and coordinating the follow up and closure of all open items.
  • Maintaining the internal and external audit schedule and QP declarations. Assist with audits when required.
  • Maintaining Bona Fides of suppliers and customers, including audit documentation and quality agreements.
  • Performance of documentation reviews for registration documents and QMS documents in general
  • Supporting batch release activities when needed
  • Ensure that training plans are implemented and training records are maintained
  • Support Pharmacovigilance and Regulatory Affairs as directed when required, e.g. compliance activities, co-ordinating documentation requests
  • Other ad hoc duties as and when required
  • Acting as EU quality contact person with partners and subsidiaries for internal quality compliance matters
  • Co-ordinate with other departments and Consultants to support the business needs
  • Proactively drive a quality culture within the organisation

Requirements
  • A degree in a life science or pharmacy discipline.
  • Minimum 4 years of quality systems experience or equivalent in the pharmaceutical industry
  • A good understanding and working knowledge of GDP and GMP
  • Familiarity with relevant Legislation, Regulations and Guidelines applicable in Ireland and EU
  • Proficiency in the English language with strong verbal and written communication skills is essential
  • Ability to process technical information
  • Accuracy and excellent attention to detail
  • Excellent organisational skills
  • Good interpersonal skills
  • Excellent Computer skills (Microsoft Word, Excel)