Staff Augmentation Services -
Quality Assurance/Control Services
Pharma-Tech Process and Facilities Services, LLC provides technical support and quality engineering services in support of virtually all aspects of biopharmaceutical manufacturing operations. Our project management and technical service personnel can identify efficiencies and strategies to streamline compliance through quality assurance and quality control organizations with thorough understanding QA/QC best practices, regulatory requirements and a deep cross-functional understanding of complex biopharmaceutical manufacturing organizations and quality systems.
Pharma-Tech Quality Assurance and Control Services capabilities include:
- Quality Engineering and Technology
- Quality Subject Matter Expertise
- Quality Project Management Best Practices
- Quality Engineering Best Practices
- Cross-Functional Communication
- Owners Representation and oversight
- Organizational Development
- Operational Excellence
- Information Technology
- Technology Evaluation
- Aseptic Processing
- Cell Culture and Upstream Processing
- Purification and Downstream Processing
- Formulation and Fill Finish
- Technical Writing
- Quality Review
- Technology Transfer
- Start-Up and Commissioning
- 3rd Party Inspection and Verification
- Manufacturing Support
- Change Control and Management
- Special Projects
- Single-Use Disposable Technology Validation
- Batch Records
- Criticality and Impact Assessment
- Risk Assessment and Mitigation
- FDA 483 and Warning Letter Remediation
- Integrated Quality Assurance Strategies
- GDP Review
- Standard Operating Procedures (SOPs) and Guidelines
- Training
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