Senior Qa Validation Specialist

4 weeks ago

Dublin, Ireland Lsc, Life Science Consultants Full time

Overview
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
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 for 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 (QRA/ES)
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 / Qualifications
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
Visa / Employment Requirements
Applicants interested in contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa.
We are unable to provide visa sponsorship.
Thank you for your understanding.
How to apply
Apply via this advert or contact Siobhan Cummins at if you have any questions about this opportunity.
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