LSC have an exciting contract opportunity for Senior Quality Assurance Professional - Plant Technical Quality Assurance (PTQA). This is your chance to be part of a company that's committed to unlocking the potential of biology for patients suffering from serious illnesses. As a Senior Quality Assurance Professional - Plant Technical Quality Assurance (PTQA), you'll play a crucial role in ensuring the highest standards of quality in this cutting-edge facility.
ABOUT THE ROLE:
The Plant Technical Quality Assurance (PTQA) Specialist is a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
- Act as the Quality point of contact during New Product Introductions, Technology Transfer, and Process Validation activities for Aseptic products
- Review and approve Process Development and Validation documentation
- Provide Quality direction at Change Control and Deviation Review Boards
- Oversee change control and Deviation/CAPA records
- Ensure all activities meet site and regulatory expectations
ARE YOUR SKILLS A MATCH?
- University degree in Science or Engineering-related discipline (preferred)
- 7+ years of experience in the pharmaceutical or biotechnology industry
- Strong understanding of Validation and New Product Introduction principles
- Experience in aseptic manufacturing
- Expertise in change control, non-conformance, corrective and preventative actions, and validation practices
- Excellent critical thinking and communication skills
- Ability to work independently and collaboratively in a team-based culture
Please apply directly via this advert or contact Kathy Gillen on 021 4718212 to discuss this opportunity in more detail.
All applicants must have a valid work permit for at least 12 months. LSC do not offer work permit or visa sponsorship.
