QA Shopfloor Oversight Associate

We are looking for:

A QA Shopfloor Oversight Associate to maintain a high-visibility Quality Assurance presence on the shopfloor, ensuring real-time compliance with Good Manufacturing Practices (GMP) and data integrity standards within a pharmaceutical manufacturing environment.

As a QA Shopfloor Oversight Associate you will:

• Maintain a continuous and visible presence within manufacturing and packaging areas.
• Spend the majority of working hours on the shopfloor rather than in office-based activities.
• Observe production activities in real time to ensure compliance with GMP.
• Engage with production personnel to promote quality awareness and compliance.

Rotational Oversight Across Production Areas

• Rotate regularly between different production suites (e.g., every 1–2 days).
• Ensure QA oversight across all manufacturing stages, including dispensing, granulation, compression, coating, and packaging.
• Monitor consistency of compliance practices across departments.

Real-Time GMP Compliance Monitoring

• • Perform on-the-floor QA oversight of:
    • Line clearance activities
    • Batch manufacturing and packaging operations
    • Adherence to approved SOPs and GMP requirements
• Identify, document, and escalate deviations or non-compliance.
• Support immediate corrective actions in collaboration with production and QA teams.

  Data Integrity Oversight (ALCOA+)

  • Monitor documentation practices within batch records and logbooks.
  • Ensure compliance with ALCOA+ principles:
    • Attributable
    • Legible
    • Contemporaneous
    • Original
    • Accurate
  • Identify data integrity risks and ensure timely correction and escalation.

  Collaborative Shopfloor Support

  • Work closely with production teams to support compliant execution of manufacturing activities.
  • Provide guidance on GMP and documentation practices where required.
  • Maintain QA independence while fostering a collaborative working environment.

  Periodic QA Observation Reporting

  Prepare structured daily reports including:

  a. Scope of Activities

  • Areas visited
  • Personnel engaged
  • Products and batch numbers observed
  • Manufacturing steps reviewed

  b. Observations

  • GMP compliance observations
  • Data integrity findings
  • Deviations or potential risks identified

  c. Actions Taken

  • Immediate corrections implemented
  • Escalations to QA management

  d. Inspection Readiness

  • Ensure reports are detailed, clear, and suitable for Health Authority inspections (e.g., FDA, EMA).

  Continuous Improvement & Audit Readiness

  • Identify recurring issues and support root cause investigations.
  • Contribute to process improvements and strengthening of GMP practices.
  • Support maintaining a constant state of audit readiness across manufacturing operations.

What you will bring:

• Bachelor’s degree in Pharmacy, Chemistry, Biology or related Life Sciences field.
• Recent graduate or up to 1–2 years of experience in a GMP-regulated pharmaceutical manufacturing environment is preferred. 
• Familiarity with shopfloor operations and QA processes is an advantage.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint)
• English: fluent (written and spoken)
• Greek: fluent (written and spoken) is an advantage