Senior QA Shopfloor Oversight Scientist

We are looking for:

A Senior QA Shopfloor Oversight Scientist to maintain a high-visibility, Quality Assurance presence on the shopfloor, ensuring real-time compliance with Good Manufacturing Practices (GMP), data integrity principles, and internal procedures within a pharmaceutical manufacturing environment. The role provides independent oversight of manufacturing and packaging operations, proactively identifies risks, supports immediate corrective actions, and contributes to a culture of quality, compliance, and continuous inspection readiness.

As a Senior QA Shopfloor Oversight Scientist you will be responsible for:

• Maintain continuous and visible QA presence within manufacturing and packaging areas.
• Provide real-time oversight of operations.
• Independently assess compliance of production activities with GMP requirements.
• Act as a key QA representative within operational areas.
• Perform systematic rotation across production suites to ensure comprehensive QA coverage.
• Monitor all stages of manufacturing, including dispensing, granulation, compression, coating, and packaging.
• Ensure consistent application of GMP standards across all production areas
• Perform in-depth QA oversight of:
  • Line clearance activities
  • Batch manufacturing and packaging operations
  • Adherence to SOPs and GMP requirements
• Identify, assess, and document deviations, non-compliance, and risks.
• Initiate and support immediate corrective actions in collaboration with Production and QA teams.
• Escalate critical issues to QA management where required.
• Ensure compliance with ALCOA+ principles in all shopfloor documentation practices.
• Review batch records, logbooks, and real-time entries for accuracy and completeness.
• Identify and address data integrity risks, ensuring timely correction and escalation.
• Apply risk-based thinking to identify potential quality and compliance issues.
• Provide on-the-spot guidance to production teams to prevent deviations.
• Support QA decision-making through timely and accurate reporting of observations.
• Work closely with Production, Quality Control, and Engineering teams to ensure compliant execution of operations.
• Provide expert guidance on GMP and documentation practices.
• Maintain QA independence while fostering a collaborative and solution-oriented environment.
• Prepare structured daily reports including:
• Scope of Activities
  · Areas visited
  · Personnel engaged
  · Products and batch numbers observed
  · Manufacturing steps reviewed
• Observations
  · GMP compliance findings
  · Data integrity observations
  · Identified risks or deviations
• Actions Taken
  · Immediate corrections implemented
  · Escalations and follow-up actions
• Inspection Readiness
  · Ensure reports are clear, detailed, and suitable for regulatory inspections (e.g., FDA,EMA)
• Identify recurring issues and support root cause analysis and CAPA activities.
• Contribute to continuous improvement initiatives related to GMP compliance.
• Support maintaining a constant state of inspection readiness within manufacturing operations.
• Provide on-the-floor coaching and guidance to production personnel on GMP and data integrity.
• Support training initiatives to strengthen compliance awareness across the shopfloor.

What you will bring:

• Bachelor’s degree in Pharmacy, Chemistry, Biology or related Life Sciences field is required.
• Minimum of 3–5 years of experience in a GMP-regulated pharmaceutical manufacturing environment.
• Proven experience in QA operations or shopfloor oversight is required.
• Familiarity with manufacturing processes and GMP requirements.
• Strong knowledge of EU GMP requirements and data integrity principles (ALCOA+).
• Ability to work independently and make risk-based decisions.
• Strong observational and analytical skills.
• Effective communication and interpersonal skills.
• High level of integrity and attention to detail
• Proficiency in Microsoft Office Suite 
• Familiarity with quality systems and documentation tools. 
• Good knowledge of Greek and English