Senior Quality Assurance Specialist
This is a key role in the quality assurance team where you will be responsible for ensuring that all manufacturing and product release activities are in alignment with regulatory requirements.
Key Responsibilities:
* Review and approval of batch records to ensure compliance with current Good Manufacturing Practices (cGMP)
* Participate in QA documentation management, resolve documentation issues and help produce relevant metrics to monitor efficiency
* Support change management, deviations and corrective and preventative action (CAPA) systems as required
* Support ongoing review of events, deviations and non-conformances associated with batch release activities
* Support site risk management procedures
* Support the implementation and continuous improvement of an effective quality management system
* Provide QA support to Quality Control including review of Quality Control (QC) raw data
Required Skills and Qualifications:
* Third level degree in a life science discipline
* At least 5 years Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP
* Good knowledge of regulatory and cGMP guidelines and directives
* Excellent interpersonal and communication skills
* Self-motivation and computer literacy
Benefits:
* Competitive salary and bonus
* 25.5 days holiday per annum plus public holidays
* Defined contributory pension plan
* Private medical insurance for you and your family
Others:
* Lifting light weights (e.g. batch paperwork folders), sitting, standing and walking
* Visa status: must be eligible to work and live in Ireland