Senior Quality Systems Specialist

  • Reference: GY44626AO
  • Job Type: Permanent
  • Location: Limerick
  • Category: Science, Pharmaceutical & Food

Summary:
Maintains site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.

• Administration and oversight of site quality systems including but not limited to:
  – Deviations
  – CAPA
  – Change Control
  – Audits
  – Customer Complaints

• Responsible for review and approval of the following types of documents, relating to area functions:
  – failure investigations
  – change control documents
  – corrective/preventative action documents
  – standard operating procedures

• Maintaining electronic systems used for Change Control and Deviation Management.

• 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 site quality systems.

• Actively participate in continuous improvement initiatives.      

• Participates in regulatory and customer audits.

• Collaborates with functional departments to resolve issues and maintain compliance.

• Identify gaps in systems and develop feasible plans for correction.

• Training of personnel on quality system processes.

 

Requirements:

  • Requires BSc/BEng in scientific discipline or related field with 5+ years of relevant work experience in pharmaceutical or related industry.
  • Supervisory experience preferred.
  • Good working knowledge of electronic Quality Management Systems and associated metric generation preferred.

Proficient at report generation using Excel and other MS Office applications.

For a confidential discussion and more information on the role/company please  email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

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  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
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