An exciting new opportunity for a Quality Assurance Specialist to join a leading medical company based in Carlow. The QA Specialist (NPI / DS / Materials) will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities
Overview of Main Responsibilities
- Ensuring that the process for the introduction of biologics/vaccines is in compliance with cGMP and the associated regulatory requirements.
- Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing.
- QA oversight on the receipt and release of Drug Substance to site.
- Role Functions
- Provide quality oversight and direction for the introduction of new products, drug substance and materials onto site covering the end to end strategy.
- Quality point of contact at both a site level and for all external inputs (Transfer Site QA/QC/ Regulatory), including co-ordination of/attendance at Quality working group meetings.
- Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
- 3-5 years’ experience in a quality role, ideally in pharmaceutical manufacturing environments.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Knowledge of cGMP and GDP preferred
- Report, standards, policy writing skills required.
- Equipment and process validation.
- Sterile filling processes and equipment.
- Lean Six Sigma Methodology experience desired.
- Proven decision making capability with accountability and responsibility
For a confidential discussion and more information on the role, please contact Kevin Griffin