Visual Inspection Specialist

6 days ago

Sligo, Sligo, Ireland beBeeVisualInspection Full time €50,000 - €70,000

Job Overview:

This role is a vital part of the manufacturing operation for biologics in Sligo.

It's a 12-month contract position that requires collaboration with cross-functional teams to ensure compliance with safety, regulatory, and organizational requirements.

Responsibilities include:

  • Developing and modifying procedures as needed to support the manufacturing operation;
  • Participating in process, equipment, and facilities validations efforts and projects implementations;
  • Reviewing and approving process-related commissioning, qualification, and validation protocols for completeness and accuracy;
  • Executing protocols in a timely basis to meet project schedule requirements;
  • Leading Process FMEAs for Visual Inspection and establishing, optimizing processes for certification of technicians;
  • Maintaining a defect library and trending Visual Inspection Defects;
  • Ensuring alignment of Site Visual Inspection procedures with Global Guidance Documents and Regulatory Requirements;
  • Providing technical input to guide SOP development for Visual Inspection;
  • Leadership of manufacturing and validation activities during project life cycle;
  • Coordination with internal/external stakeholders for particle/defect evaluation;
  • Investigating process exceptions or malfunction incidents affecting the process.

Requirements:

  • Relevant third-level qualification in an engineering, science, or technical discipline (Degree Level or Master's Preferable);
  • At least three (3) years of combined experience in Technical/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization;
  • Experience in the manufacturing environment of a biotechnology, pharmaceutical, or health care plant, preferably with knowledge of clean utilities.

A strong understanding of manufacturing processes, including those for biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilization operations is desirable.

The ideal candidate will have a proven track record of delivering results in a fast-paced environment and be able to work collaboratively with cross-functional teams.

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