Quality Assurance Specialist

2 days ago

Sligo, Sligo, Ireland beBeeCompliance Full time
Product Transfer Specialist

 

Job Description

 

At our site in AbbVie Manorhamilton, Sligo, we are currently recruiting a Product Transfer Specialist to join our team. This role is responsible for ensuring that new products manufactured at the site meet requirements of applicable regulatory requirements and company procedures and policies.

 

Responsibilities:

  • Maintaining the effectiveness of the integration of new products into the quality system.
  • Ensuring compliance with regulatory requirements and company policies.
  • Supporting product transfers from development through to commercialization, collaborating closely with cross-functional teams to address quality concerns and ensure mitigation.
  • Evaluating vendors, managing technical agreements, and reviewing product specifications.
  • Collaborating with CMC QA, R&D, S&T, and other functional groups to maintain roles and responsibilities and identify potential quality issues.
  • Coordinating site reviews of product-related material specification documents and analytical test methods.
  • Generating corrective action documentation and attesting product transfer deliverables.
  • Providing expertise to internal auditors and outside regulatory agencies on product transfers and technology.

 

Qualifications:

  • A third-level qualification in a science or quality discipline.
  • Minimum 3 years' experience in pharmaceutical or sterile manufacturing environments.
  • Strong written and verbal communication skills.

 

Benefits:

  • Equal opportunity employer.
  • Commitment to operating with integrity and driving innovation.

 

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