Collins McNicholas

QC Specialist – Change Control 

This role will involve coordinating and maintaining the Change Control process on site to ensure that this key element of the  Quality Management System operates continuously in a compliant manner while meeting ongoing business requirements.

You will also support other quality system elements such as Deviations, CAPA or QRM as required.

Responsibilities:

  • Ensure compliance in all aspects of Quality for the manufacturing, quality systems, quality control, validation, facilities, and materials management.
  • Administration and overseeing the Change Control process.
  • Responsible for one or more of the site quality systems including but not limited to;

–          Deviations

–          CAPA

–          Quality Risk Management

  • Responsible for review and approval of associated change control documents, and other documents such as:

–          Failure investigations

–          corrective/preventative action documents

–          Standard operating procedures

  • 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 and customer audits.
  • Participates in quality risk assessments.
  • Collaborates with functional departments to resolve issues and maintain compliance
  • Identify gaps in systems and develop feasible plans for correction
  • Training of personnel on change control and other quality system processes

 

Requirements:

  • Bachelors of Science or Engineering or related field.
  • 3+ years experience in a pharmaceutical or regulated environment.
  • Analytical, attention to detail and utmost ethical behaviour.

 

For more information or to apply for this position, please call Ben Forde on 061-512270

 

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