Senior Technologist - ProductionNew!

• Perform routine QA oversight on the manufacturing floor.
• Verify compliance with approved manufacturing procedures and batch manufacturing records.
• Perform and document QA verification of line clearance.
• Verify correct material and product status before use, processing or transfer.
• Verify compliance with approved process parameters, in-process controls and critical process controls.
• Verify completion and accuracy of manufacturing records.
• Monitor critical manufacturing activities and identify GMP departures.
• Participate in manufacturing-related deviation investigations and CAPA.
• Provide QA oversight during validation and qualification activities involving production processes and equipment.

Qualifications & Experience:

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Biochemistry, Biomedical Sciences, Pharmaceutical Sciences or a related science discipline.
• Hands-on experience in quality assurance, pharmaceutical production or GMP manufacturing operations.
• Strong understanding of GMP principles, pharmaceutical manufacturing processes and quality control requirements.
• Knowledge of Batch Manufacturing Records, line clearance, material and product status control, IPCs and critical process parameters.
• Knowledge and practical experience in deviation management, CAPA, change control and root-cause analysis.
• Familiarity with process validation, equipment qualification and contamination-control principles.
• Knowledge of Quality Risk Management principles and their application to manufacturing operations.
• Experience in pharmaceutical, vaccine, biologics or other regulated manufacturing environments.
• Knowledge of WHO GMP, ICH, European Pharmacopoeia and other applicable regulatory requirements.
• Experience supporting GMP audits, regulatory inspections and inspection-readiness activities.

Skills & Competencies:

• Attention to detail in documentation.
• GMP compliance and inspection readiness.
• Deviation investigation and root-cause analysis.
• Clear communication and record keeping.
• Independent judgment on the manufacturing floor.