LSC have a great contract opportunity for a Senior Quality Assurance Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 10 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Quality Oversight of new equipment qualification:
- Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation
- Act as the Quality point of contact and decision-maker c & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.
- Validation and Documentation:
- Quality review and approval of validation documentation, including:
- Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAES).
- Validation Plans, Protocols (IQ, OQ, PQ), and associated reports.
- Ensure robust and compliant validation documentation to support site activities.
- Risk Management and Compliance:
- Conduct risk assessments and develop mitigation strategies for potential challenges in equipment introduction.
ABOUT YOU - ARE YOUR SKILLS A MATCH?- University degree in a Science or Engineering-related discipline.
- Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.
- Proven expertise in new equipment introduction, technical transfer, PPQ execution, and lifecycle management.
- Strong understanding of validation principles and regulatory requirements for C & Q / Validation (FDA, EMA guidelines).
- Experience with change control, non-conformance resolution, and CAPA implementation.
- Excellent organizational, communication, and collaboration skills.
- Ability to work independently with minimal supervision and operate effectively across functional boundaries.
- Critical thinking and problem-solving abilities.
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please note that we are unable to provide visa sponsorship. Thank you for your understanding.
Apply via this advert or contact Gráinne Hodnett on 021 4777 329 if you have any more questions about this opportunity!
