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Senior Automation Compliance Specialist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Dublin
  • Sector: Scientific
  • Date posted: 13/02/2019
  • Job reference: BBBH96909

Senior Automation Compliance Specialist

  • Dublin
  • Permanent
  • Neg Salary

The Senior Automation Compliance Specialist role will involve steering the entire development of the facility's Quality Assurance IT strategy, ensuring the processes conform to company policies and comply with cGMPs, Health Agency regulations and all other applicable governing regulations, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world.

Role Responsibilities

  • Be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labelling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
  • Be involved in all quality-related activities for computerized systems which are required by the Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity.
  • Work closely with stakeholders and SMEs from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
  • Inspire and motivate your team to uphold a high-performance culture that drives Quality Assurance excellence;

Qualifications / Experience

This role requires a seasoned QAA Senior Specialist with a minimum of 5 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.

A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.

Technical

Must have at least 3 years of experience in delivering validated IT solutions or an application support role in a regulated environment.

People

  • The motivation to be an inspiring member of a high performing team.
  • The desire to continuously learn, improve and develop
  • A great communicator, decisive decision maker and proven ability to deliver excellence
  • Confidence to direct off-site suppliers to the project, willingness to support the team and a laser light focus to deliver excellence
  • Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
  • Experience with new product introductions and/or process qualification/technology transfer

Education

Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance their career.

PLEASE NOTE: Candidates must have full working rights in Ireland i.e. a current Stamp 4 Visa or an EU Passport to be eligible to work in Ireland to be considered for the role.

For more information or to apply to the role contact Emmet on 01 6455250 or email to emmet.mceneaney AT experis.ie.

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