Quality Assurance Specialist

2 weeks ago

Cork, Cork, Ireland beBeeValidation Full time €80,000 - €100,000
CQV Lead Role

As a key member of our team, the CQV Lead will oversee and coordinate CQV project activities in line with the site project strategy. This involves working closely with cross-functional teams to develop and execute an optimum validation strategy.

Main Responsibilities:
  • Lead and coordinate CQV projects to ensure timely execution and compliance with industry regulations.
  • Support the transition to a digitized C&Q platform by ensuring seamless integration and minimal disruption to ongoing processes.
  • Develop and maintain project plans, schedules, and budgets to align with business objectives and ensure effective resource allocation.
  • Act as the primary point of contact between clients, internal teams, and external vendors to drive project success and foster collaborative relationships.
  • Manage and coordinate all CQV documentation to support CQV activities and ensure accurate record-keeping.
  • Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards.
  • Support continuous improvement initiatives by implementing best practices in project execution and quality assurance, driving process efficiency and effectiveness.
Requirements:
  • Experience in deploying or working extensively with a digitized C&Q platform (e.g., Kneat Solutions) to streamline workflows and improve data management.
  • A clear understanding and previous experience in deployment and execution of a Risk-Based Validation (RBV) process in line with ISPE guidelines to ensure compliance and regulatory adherence.
  • Proven experience managing teams or projects in a fast-paced, complex environment to prioritize tasks, manage multiple stakeholders, and achieve project goals.
  • Relevant qualification and/or 10+ years of experience in biotech/pharmaceutical industry qualifying GXP systems to ensure expertise and knowledge in regulatory requirements.
  • SIGNIFICANT PROJECT LIFECYCLE EXPERIENCE IN DELIVERING CQV PROJECTS FOR CAPITAL EXPENDITURE PROJECTS.
  • A clear understanding of regulatory requirements for EU and other regulatory bodies ensuring CQV is delivered meeting all regulatory requirements and guidelines.
  • Excellent verbal and written communication skills, with experience developing strong working relationships with other departments and stakeholders.
  • Strong analytical problem-solving skills and dynamic decision-making abilities to navigate complex situations and drive positive outcomes.

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