Specialist - Quality Assurance

Are you ready to make a significant impact in the world of aseptic manufacturing and packing? The Senior Specialist - Quality Assurance is accountable for delivering QA leadership and oversight for aseptic manufacturing and packaging operations on the night shift. You will provide GMP and aseptic processing expertise, assure cleanroom compliance, influence operational decisions within the Process Execution Team (PET), and support timely and compliant product release. This role is pivotal in safeguarding patient safety, regulatory compliance, and value stream performance. Accountabilities:

• Cleanroom and Aseptic Oversight: Provide technical guidance on cleanroom standards, aseptic techniques, and environmental controls aligned to current EU GMP Annex 1 and internal procedures.
• Deviation and CAPA Management: Advise on deviations, lead or contribute to root cause analysis, and agree CAPAs to prevent recurrence and improve process robustness.
• Product Quality/Release Support: Support or perform product release activities as required, ensuring batch documentation, data integrity, and compliance.
• GMP Training and Coaching: Complete required PET GMP training and coach manufacturing personnel on cGMP, aseptic behaviours, data integrity, and contamination control.
• Compliance and Continuous Improvement: Proactively identify compliance risks and opportunities for business improvement, efficiency savings, and lean optimization.
• Change Control: Lead or support local/cross-functional change controls ensuring validated state and regulatory alignment.
• Quality Systems Execution: Contribute to PQR, quality risk management, metrics (e.g., deviations, CAPA effectiveness), and documentation updates.
  
  Degree (or equivalent) in a scientific discipline (e.g., pharmacy, microbiology, chemistry, biochemistry, engineering). A clear, comprehensive grasp of the quality assurance function, along with a strong understanding of other business functions and how they work together to achieve business objectives in a lean manufacturing environment.
• Quality Assurance in Pharmaceutical Manufacture with strong understanding of cross-functional operations in a lean environment.
• Aseptic Processing or Packing knowledge, including cleanroom behaviours and contamination control principles.
• Current GMP Knowledge and working familiarity with EU GMP Annex 1, ICH Q9/Q10, and data integrity principles.
• Communication and Influencing skills with cultural awareness; ability to coach operators and technicians.
• Decision-Making within general operating guidelines using risk-based, science-led judgment.
• Permanent Night Shift availability.
Desirable Skills/Experience:
• Experience in Aseptic Manufacturing operations and sterile packaging lines.
• Microbiology Experience, including environmental monitoring, sterility assurance concepts, and interpretation of microbiological data.
• Quality Risk Management application (FMEA, HACCP).