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Quality Control Microbiology
- Investigating Microbial Contaminations
- Risk assessment
- Total Quality Management of Microbiological Quality Control
- Plant sanitization problem solving, biocontamination control and risk analysis
- Selection and qualification/validation of disinfectants for the manufacturing facilities
- Assistance with facility design for contamination control
- Cleanroom performance qualification (PQ) protocols and reports
- Development of programs for environmental monitoring, water monitoring and
compressed gases monitoring
- Training of personnel in executing environmental monitoring and water monitoring
programs, microbiological methods, and aseptic techniques
- Writing/modifying procedures per current compendial requirements
- Protocol development and validation of microbiological assays and equipment
- Auditing QC microbiology laboratories, contract laboratories and microbiological
aspect of manufacturing
- Analyze and prepare FDA 483 responses
- Designing efficient workflow systems for QC laboratories to facilitate timely review
and action
- Laboratory and stability data analysis and reports
- Performance of validation audits and report reviews
- Developing validation protocols and reports
- Developing and modifying test methods, SOPs, and specifications
Process Development and Validation
- Pharmaceutical Equipment Development ( User Requirement Specifications and
Vendor assessment).
- Equipment Qualifications (FAT, SAT, IQ, OQ and PQ Protocols)
- Equipment Cleaning Validations
- Aseptic Process Design and Development
- Barrier Isolator System development and implementation
- Aspetic Process Simulation Testing Protocols / Management
- Sterilization Cycle Development (Gamma Irradiation, E-Beam, Ethylene Oxide,
Vapor Hydrogen Peroxide, Steam and Dry Heat Serilization)
- Microbiological Control (bioburden and endotoxin) in Pharmaceutical and Medical
Device Manufacturing systems
- Aseptic Spray Drying Development for API particle engineering
- Nondestructive testing protocol development for device quality assurance
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Quality Assurance and Compliance
- Developing and streamlining Quality Systems
- Management of Quality Assurance Function
- Developing and revising of Quality Assurance documents and procedures
for Compliance
- Implementing Paper Based Document Control Systems
- Implementing Electronic Document and Training Tracking Systems
- Assistance with preparations for Pre-Approval Inspections, routine FDA Inspections
and State Licensure Inspections.
- Establishment and maintenance of Risk Management programs
- Developing of tracking systems for Deviations, Out of Specification Results,
Corrective Actions and Quality Investigations and Change Control.
- Annual product and quality reviews
- Establishing quality agreements and service agreements with CMOs
- Technology Transfer Documentation
- Assistance with Internal, External and Vendor Audits
- Data compilation, review and reports for regulatory filings
- GAP Analysis
- GMP Training
Manufacturing Support
- Assistance with manufacturing related documentation
- On site training and qualification of manufacturing personnel in aseptic techniques
- Master Cell Bank manufacture and re-certification
- Developing batch records and implementing effective pre and post batch
record execution documentation to reduce deviations
- Implementation of Paper Based and Electronic Materials Management Systems
- Project Management
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