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GMP Compliance Professional

3 weeks ago

Cork, Cork, Ireland Careerwise Recruitment Full time

CareerWise Recruitment is seeking a highly skilled Quality Assurance Specialist to join our client's team on an initial 12-month basis. This role involves ensuring that all quality-related activities are conducted in accordance with Good Manufacturing Practice (GMP) regulations.

The ideal candidate will have a Bachelor's Degree in a scientific or technical discipline and at least 3-5 years of experience in a quality, validation, or compliance role within the biological and/or pharmaceutical industry.

The successful applicant will be knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals and able to apply GMP regulations to all aspects of the position.

Key Responsibilities:

  • Ensure all quality-related activities are conducted in accordance with GMP regulations
  • Carry out tasks related to the administration of event management systems, including review and approval of event, deviation, and customer complaint documentation
  • Administer site change control systems and compile annual product reviews
  • Support all validation activities on site as described in the Site Validation Master Plan

Requirements:

  • Bachelor's Degree in a scientific or technical discipline
  • At least 3-5 years of experience in a quality, validation, or compliance role within the biological and/or pharmaceutical industry
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals