Quality Compliance Specialist - Change Control

Competitive
Permanent
Limerick
14 May 2020
BBBH759463

This company will give you brilliant exposure to a fast paced, full on facility where the growth potential and promotional opportunities are well within your grasp.

I am currently working with a leading biotechnology company that invents life-transforming medicines for people with serious diseases. This company are going through huge expansion at the moment and are on the look out for a Quality Compliance Specialist on a full time basis.

This company will give you brilliant exposure to a fast paced, full on facility where the growth potential and promotional opportunities are well within your grasp. This is an excellent opportunity for anyone who loves to be kept busy and are highly career focused.

The key focus of this role is to coordinate and maintain the site Change Control process to ensure that this key element of the QMS continuously operates in a compliant manner while meeting ongoing business requirements. The role may also involve supporting other quality system elements such as Deviations, CAPA or QRM as required.

Key responsibilities include:

  • Responsible for ensuring compliance with all aspects of Quality inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
  • Primarily responsible for administration and oversight of the Change Control process but may also be responsible for one or more of the site quality systems including but not limited to; CAPA's, deviations and Quality Risk Management
  • Responsible for review and approval of associated change control documents, and other documents such as SOP's, CAPA documentation and Failure investigations
  • Maintaining the electronic systems used for Change Control, Deviation Management and CAPA.
  • Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements
  • Provision of monitoring and trending metrics associated with change control and other site quality systems
  • Actively participate in continuous improvement initiatives.
  • Participates in regulatory, customer audits & quality risk assessments.
  • Training of personnel on change control and other quality system processes

Education and Experience:

  • Requires BSc/BEng in scientific discipline or related field with 3+ years of relevant work experience in pharmaceutical or related industry.

If this sounds of interest, or if you would like to hear more then click the 'Apply Now' button below or reach out to Kellie on kodonovan@morganmckinley.com or 021 2300 300.

Other live vacancies:

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  • Quality Lead - Permanent - Essential Oils - Cork
  • Quality Officer - Permanent - FMCG - Cork
  • Product Release Manager - Permanent - FMCG - Cork
  • Quality Systems Associate - Permanent - Biopharma - Cork

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Kellie O'Donovan's picture
Consultant | Engineering Recruitment - Quality & Validation
Cork 353 (0) 21 2300300 | kodonovan@morganmckinley.com