QA Specialist

QA Specialist

Reporting to the AAA Site Remediation Lead, the AAA Remediation QA Specialist is responsible for GMP quality assurance oversight of remediation activities and the on-time execution of project deliverables, ensuring successful completion of remediation commitments and successful inspection outcomes. There will be a strong focus on equipment validation, compliance, record backlog elimination, and sterility assurance. This is a high visibility and demanding role, bringing with it the opportunity to learn about the company, shape global healthcare trends and have impact at the highest level. Major accountabilities: Responsibilities include but not are limited to:

• Execute and/or approve deliverables for the Site Remediation Project Plan enabling overall strategic implementation of remediation activities within the site's commitments to Health Authorities.
• Work in close collaboration with site-based SMEs to ensure the implementation of robust, high-quality deliverables, with clear alignment between inspection SMEs and site leadership.
• Review and approve remediation actions related to facility, computerized systems, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted. Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC remediation work.
• Review and approval of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation related matters in support of record backlog reduction.
• Responsible for routine reporting of the status of deliverables and risk to the Site Remediation Lead and delivering relevant content for governance meetings.
• Drive the site's Inspection Readiness program for regulatory inspections, Client baseline audits /audits and providing hands-on support at sites in preparing for inspections / audits
• Define and plan agendas, deliver content and/or lead preparation for project governance meetings, as delegated by the Site Remediation Lead.
• Actively drive high quality deliverables at the site by promoting a high standard of Quality Culture. Helps build and drive a culture of compliance throughout the organization.
• Inspire change management initiatives and embed collaboration forums across the sites and as required with stakeholders. Control project scope to limit schedule changes and to capture changes of scope that may arise.
• Partner with Site QA to ensure the Primary SME is trained and ready to deliver remediation evidence during regulatory inspections, Final project handover, including Remediation Continuity Plan as needed.

Key performance indicators:

• Successful and timely completion of the site's Remediation Plan deliverables, meeting strategic objectives of AAA Global Remediation Task Force
• Successful Health Authority Inspections

Financial responsibility: (Budget, cost, sales, etc.) Adhere to established budget and costs Impact on the organization: High; significantly contributes to success of AAA RLT objectives by ensuring cGMP-Compliance with focus on Successful Health Authority Inspections & correct, cGMP compliant decisions as part of critical Quality Issues (e.g. market actions).

Requirements:

• B.S. degree in Science, Engineering or related field with 5 years' relevant experience or MSc with 3 years of relevant experience.
• 5 years of experience in Pharmaceutical Manufacturing preferred, at least 3 years combined of relevant experience in quality-based roles including experience in GMP and/or laboratory operations required.
• Proven track record and practical experience in establishing and maintaining quality systems, in facility changes and validation as well as successfully managing authority inspections from major HA's, e.g., USA, EMEA, Canada, Japan, Brazil
• In-depth knowledge of cGMP's, especially FDA regulations 21 CFR Parts 11 with preferred understanding of regulations for computerized systems
• Strong understanding and operating awareness of working in a pharmaceutical company. Experience in regulatory agency and partner/collaborator inspections.
• Good understanding of local/National Health Authorities regulations and Client standards
• Demonstrated ability to problem solve and mediate complex issues. Project management capabilities preferred.
• Strong communication, leadership and team working skills
• Effective in prioritizing, shows the appropriate sense of urgency around prioritized tasks. Flexibility and ability to prioritize and manage multiple tasks simultaneously
• Creative thinker in ways in which we can ensure better compliance and systems (A risk-based approach to Quality and Compliance)
• Demonstrated excellence in written and verbal communication. Ability to effectively communicate at all levels in the organization – oral and written
• Demonstrated ability to work cross-functionally
• Highly motivated, driven and have a passion to be part of a fast-paced team