Quality Assurance Specialist Job Description
We are seeking a Quality Assurance Specialist to join our Pharmaceutical organization in Dublin. The role will be responsible for ensuring adherence to safety standards and regulatory requirements.
* Main Responsibilities:
* Ensure adherence to safety standards and SOPs in all activities.
* Review and approve production batch records and associated documentation.
* Provide real-time quality oversight and support for production unit operations.
* Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
* Offer Quality Assurance support for on-the-floor investigations and deviations.
* Review and approve deviations for closure, ensuring compliance with appropriate documentation.
* Participate in customer complaint investigations.
* Conduct routine Quality Assurance walks on the production floor.
* Review and issue logbooks, ensuring compliance with procedures.
* Provide training and guidance to staff for effective performance.
* Review and approve cGMP records, ensuring compliance with appropriate documentation.
* Support continuous improvement and Operational Excellence initiatives.
* Undertake other tasks/projects as assigned by the manager.
Requirements:
* Bachelor's degree in a relevant field.
* Minimum 2 years of experience in Quality Assurance.
* Strong knowledge of regulatory requirements and industry standards.
* Excellent communication and problem-solving skills.
Benefits:
* Competitive salary and benefits package.
* Opportunities for career growth and development.
* A dynamic and supportive work environment.