The Visual Inspection Specialist – Process Equipment is expected to :
* Act as Subject Matter Expert (SME) for visual inspection technologies within a major CAPEX aseptic
unit project, from concept through commissioning & PV. Ensure compliance with EU GMP Annex 1
(2022 revision), robust defect detection strategy, and integration of advanced digital tools (image
analytics, AI/ML) while maintaining data integrity and connectivity with MES/eBR systems.
1. Engineering & Design :
* Define and maintain URS for visual inspection systems (manual, semi-automatic, fully automated)
including camera-based and AI-assisted solutions.
* Lead design reviews ensuring ergonomic compliance, defect classification standards, and integration
with upstream/downstream processes.
* Ensure compliance with ISO 14644 for cleanroom zones where inspection occurs and Annex 1
requirements for container integrity and particle control.
* Collaborate on layout to minimize contamination risk and optimize inspection efficiency.
2. Commissioning, Qualification & Verification (CQV) :
* Develop and execute CQV plans for visual inspection equipment including IQ/OQ/PQ and
performance verification for defect detection capability.
* Validate automated vision systems per GAMP 5 (2nd ed.) and Annex 11 requirements; ensure image
data integrity and audit trail compliance.
* Coordinate FAT/SAT with vendors; manage deviations and CAPA through eQMS.
3. Regulatory & Quality:
* Ensure visual inspection processes comply with EU GMP Annex and FDA Aseptic Processing
guidance.
* Maintain defect libraries and classification per industry standards; support trending and risk
assessments.
* Implement Data Integrity principles (ALCOA+) for image capture, storage, and review workflows.
4. Digitalization & Computerized Systems :
* Integrate visual inspection systems with MES/eBR for automated batch record updates.
* Deploy AI/ML algorithms for defect detection under Pharma 4.0 principles; validate models per GAMP 5 and CSA concepts.
* Ensure compliance with Annex 11 for computerized systems and maintain cybersecurity and access
controls.
5. Procurement & Vendor Management :
* Select and manmeetssuppliers for visual inspection equipment; ensure technical specifications and documentation meet GMP and CSV requirements.
* Benchmark emerging technologies (high-speed cameras, AI vision) and drive adoption of sustainable
solutions.
6. Leadership & Change Management :
* Promote a culture of quality and continuous improvement in visual inspection processes.
* Train operators and engineers on inspection techniques, defect recognition, and digital tools.
What are we looking for?
Requirements :
* Engineering or scientific degree (Automation, Optics,
Pharmaceutical Technology) or equivalent.
* 8+ years in pharmaceutical visual inspection systems and
aseptic operations.
* Experience with automated vision systems, defect classification,
and regulatory compliance.
* Knowledge of CSV and risk-based validation approaches (ASTM
E2500 considered an asset).
* Technical: manual/semi-automatic/automatic inspection systems, camera technology, AI/ML for
defect detection.
* Standards: EU GMP Annex, ISO 14644, GAMP 5 (2nd ed.), Annex 11, PIC/S PI 041-1.
* IT/OT: MES/eBR integration, image data management, cybersecurity.
* Soft skills: stakeholder engagement, vendor negotiation, training, and change management.
Regulatory References (knowledge required) :
* EU GMP Annex 1 – Manufacture of Sterile Medicinal Products (2022 revision).
* ISO 14644 – Cleanroom standards.
* ISPE GAMP 5 – Second Edition
* EU GMP Annex 11 – Computerised Systems.
* PIC/S PI 041-1 – Data Integrity.
* FDA Guidance – Aseptic Processing