Sterile Pharmaceutical Professional

7 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €90,000
Job Description

Senior Specialist, Sterile Drug Product, QA Manufacturing Operations


As a Senior Specialist, you will play a key role in the startup of a commercial sterile drug product manufacturing facility and post-startup execution and maintenance of Quality Assurance (QA) activities related to commercial sterile drug product manufacture and release.


  • Provide QA oversight for Aseptic Sterile Drug Product processes, including formulation, filling, lyophilization, capping, and automated visual inspection.
  • Collaborate with project teams to address questions during project design, construction, and qualification, and provide QA oversight across all phases.

Key Responsibilities During Commercial Operations:


  • QA support of manufacturing operations, including commercial operations and new product introductions.
  • Batch record review and on-the-floor support of manufacturing activities.
  • Quality oversight for the inspection program.
  • QA operations review of events and investigations.
  • Authoring, review, and approval of QA-related procedures; review/approval of functional area documentation.
  • Support disposition process for commercial and clinical drug products.
  • Participation in GMP reviews for new facility construction and new equipment support systems.
  • QA support for MES implementation and development of batch records.
  • Change control assessment and CAPA evaluation/close-out.
  • Interface with relevant departments to ensure compliance with GMP and regulatory requirements.
  • Support external and internal audits.
  • Drive and support a culture of continuous improvement and safe working practices.
  • Designee for Manager, Sterile Drug Product, QA Manufacturing Operations when required.

Qualifications, Knowledge and Skills Required
  • Bachelor's degree in Science or a related discipline with 2-3+ years of QA Operations or related experience in biologics or pharmaceutical environments.
  • Clear understanding of current Good Manufacturing Practices (cGMP) requirements for manufacturing and/or systems and compliance.
  • Detailed knowledge of sterile drug product is advantageous.
  • Ability to work independently and as part of a team; open to shift work; ability to operate within a matrix to meet deadlines.
  • Excellent communication and presentation skills; strong time management and organizational skills with ability to multi-task.
  • Demonstrated behaviors and commitment to safety and quality.

This role offers an exciting opportunity to join our organization and contribute to the success of our team.

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