QA Specialist Leiden • TMC

Wij zijn een internationaal hightech consultancybureau met een team van ondernemende ingenieurs, wetenschappers en digitale experts van over de hele wereld. We bieden consultancydiensten aan onze toonaangevende klanten in diverse servicegebieden zoals:

• Technology & Engineering
• Energy & Renewables
• Life sciences & Pharma
• Digital & IT

Essential Job Duties and Responsibilities

• Provides Quality oversight to the AT Production facility at the site  
• Supports setting the GMP standards and/or provides Quality guidance for:
  • all GMP processes, e.g., Change Control, Doc Control, GMP Training, inspection readiness
  • Facility, utility, and equipment design for e.g., the new Pollux Facility
  • Technology and/or Analytical Transfer
  • Qualifications and Validations
  • Aseptic Processing and Annex 1 adherence
• Assess and review the outcome of Quality Investigations, provide support as part of the investigation teams and monitor the quality of the Root Cause investigations. Assesses non-conformances for possible impact on product quality or compliance status and decide on product disposition. 
• Provide Quality support for the development of appropriate Corrective and Preventative actions and provides Quality approval
• Escalate serious quality, compliance and /or GMP incidents to Site or Global Management and support (Global) escalation of issues, which have potential impact on the delivery of products to patients
• Participate in Hazard / Risk assessments to ensure compliance or quality is not jeopardized
• Coordinates, reviews, and provides GMP training (e.g., Non-conformances, Investigation techniques, Qualifications etc.) for site colleagues to ensure compliance to cGMP and company training requirements.
• Is involved in initiatives that lead to a higher quality and compliance culture throughout the organization, including GEMBA walks in manufacturing areas and the laboratory
• Provide review and approval of document changes and change controls
• Lead or act as member for local or global capacity/quality projects
• Optimize current and identify new ways of process and quality monitoring
• On a rotation basis is available 24/7 as QA representative for Quality issues
• Act as quality SME and participates in the preparations for (APR, Inspection readiness reports) and during inspections (FDA, EMA etc.) to accomplish a successful audits.
• Partner with site colleagues to ensure all site changes (e.g., to production processes, equipment, and systems) are conducted in a controlled and systematic manner and conform to cGMP and other regulatory requirements.

Additional Duties & Responsibilities experienced specialist QA:

• Leads and supports facility in identifying and eliminating compliance risks.
• To act as a quality representative and provide expertise to manage and participate in JBV projects to ensure compliance to cGMP and company quality requirements.
• Assess, review, and approve study protocols and reports to assure that studies will be executed in a controlled and systematic manner conform cGMP and regulatory requirements e.g., but not limited to stability, validation, analytical technical transfer
• Act as member in Quality Risk Management and /or root cause investigation sessions

Minimum education required for the position

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.

Minimum experience required for the position:

• Depending on education, BSc 6 years and for MSc 4 years of experience in a GMP regulated environment (manufacturing, QA and/or QC)
• Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.

Other Requirements:

• Proven knowledge of the biotechnological/pharmaceutical industry
• Proficiency in English both in word and in writing
• Deep understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines in Operations environment.
• Functions independently in a complex environment to make daily judgment to balance business need, regulatory requirements, and cost efficiency for all Quality decisions. Is required to determine the level of risk, magnitude and/or complexity in order to make sound judgment on when to escalate critical issues to Quality management.
• Broad knowledge of QA systems (i.e., change control, deviation management, cGMP, validation) manufacturing and laboratory processes, facilities and utilities and technical automation.

TMC is an international high-tech consultancy company that brings expertise to their clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster changing technological world. Our business cell lives by 3 principles:

• Best over biggest.
• Collaboration over individualism.
• Values and ethics over rules.

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