Adham Bashayreh

• Designed production layouts and workflows in compliance with GMP standards.
• Prepared User Requirement Specifications (URS) for critical equipment, including:
  Centrifuges, TFF systems, fermenters, bioreactors (single-use & multiple-use)
  Formulation, filling, capping, labeling systems
• Coordinated equipment procurement, installation, and commissioning.
• Managed full equipment qualification lifecycle:
  IQ (Installation Qualification)
  OQ (Operational Qualification)
  PQ (Performance Qualification)
  FAT (Factory Acceptance Testing)
  SAT (Site Acceptance Testing)
• Supervised supplier qualification to ensure raw materials, consumables, and equipment met quality standards.
• Oversaw process validation activities and ensured compliance with regulatory and internal QA requirements.
• Collaborated with cross-functional teams (Engineering, QA, Production, Supply Chain) to ensure regulatory compliance and production efficiency.

• Manage and supervise day-to-day production activities including formulation, mixing, filling, capping, labeling, and packaging.
• Ensure strict compliance with GMP standards, aseptic techniques, and company SOPs.
• Prepare and review Batch Manufacturing Records (BMR), and other controlled production documentation.
• Monitor critical parameters such as temperature, humidity, and pressure differentials throughout sterile operations.
• Supervise gowning, cleaning, sterilization (autoclaving, CIP, SIP), and aseptic handling procedures.
• Oversee personnel performance, training, and adherence to safety and gowning protocols.
• Coordinate with Quality, R&D, Supply Chain, and Engineering teams to maintain smooth operations.

Extended Responsibilities & Achievements:

• Conduct Media Fill / Aseptic Process Simulations (APS) to validate aseptic practices and operator competency.
• Monitor and control Environmental Monitoring Systems (EMS) and Particulate Monitoring Systems (PMS) to maintain sterile conditions.
• Lead Cleaning Validation and Process Validation in compliance with GMP and regulatory guidelines.
• Manage Computer System Validation (CSV) to ensure compliance with GMP, data integrity, and 21 CFR Part 11 requirements.
• Manage equipment procurement and qualification, including DHS, formulation systems, filling and capping lines, labeling machines, etc.
• Draft and review URS (User Requirement Specifications) for new equipment and automated systems.
• Design and optimize production layout to align with GMP and regulatory requirements.
• Lead investigations of deviations, perform root cause analysis, and implement CAPA.
• Apply Lean Manufacturing, Six Sigma, and ANOVA methodologies to optimize processes, reduce costs, and improve yield.
• Oversee preventive maintenance and calibration programs to ensure equipment reliability.
• Support audits and inspections (regulatory, internal, and client) and prepare required documentation.
• Drive continuous improvement strategies to enhance efficiency, compliance, and profitability.

• Oversaw and monitored inspection and testing of raw materials, in-process items, and finished products to ensure adherence to established quality standards.
• Established inspection protocols, defined sampling procedures, and determined appropriate testing equipment and methodologies.
• Supervised and validated cleaning procedures including Rinse and Swab tests.
• Ensured compliance with GMP, GDP, and internal QA procedures.
• Trained QC staff and ensured accurate documentation and reporting of all quality activities.
• Led deviation investigations, root cause analysis, and CAPA implementation.
• Supervised CHT , DHT studies and Contamination and Containment monitoring programs
• Coordinated with production and QA teams for batch release approvals and regulatory inspections.
• Participated in validation activities including Process Validation, Cleaning Validation, and Aseptic Process Simulation (Media Fill).
• Managed laboratory equipment calibration and preventive maintenance programs.
• Supported continuous improvement initiatives using Lean, Six Sigma, and statistical analysis (ANOVA).

• Performed incoming raw material inspections to ensure compliance with specifications before entering the warehouse.
• Conducted testing of finished products according to client and regulatory specifications.
• Checked packaging materials and labels to ensure accuracy and compliance.
• Monitored production procedures to maintain product quality and efficiency.
• Performed analytical testing using techniques including HPLC, UV, IR, Karl-Fischer, and Memo-Titrator.
• Applied international standards including GDP and GMP in daily activities.
• Conducted internal audits across all factory departments in coordination with the Quality Assurance team.
• Prepared and maintained QC documentation, SOPs, and laboratory reports.
• Supported process improvement initiatives and troubleshooting of production issues.
• Assisted in environmental monitoring and microbial control programs With Microbiological lab staff