- Responsible for the qualification / validation studies required to support the introduction of new manufacturing, filling and packaging processes as well as the monitoring / re-qualification of existing processes and challenging integrated lines.
- Generate list of prerequisites required prior to initiating process qualification / validation activities.
- Generate protocols, technical memos, feasibility / development studies, sampling plans, acceptance criteria, and final reports.
- Support the generation of defect inspection criteria and AQL based sampling plans.
- Develop qualification / validation rationales for requirement of number of challenge runs, bracketing, matrix, and critical process / product parameters.
- Communicate status of prerequisites, open items, deviations, execution activities and project timelines.
- Collect and tabulate laboratory data, review laboratory data for errors and discrepancies, and transcribe results into final reports.
- Generate, review and approve validation procedures.
- Generate final reports, compile historical data packages, preform statistical evaluation, generate discussion of results and scientific based conclusions, and route documents for approval.
- Generate and maintain a site process qualification / validation program plan.
- Review and approve interventions and assess product impact / potential product risk as the result of atypical interventions.
- Virtual validation – extension of team (please click the link in red for details), one of most popular services from SSRUS
- Execute validation (utility, equipment, cleaning, process) which includes protocol preparation, scheduling, protocol execution, and final report preparation.
- Conduct and/or participate in deviation investigations to identify root causes and define corrective / preventative actions (CAPAs).
- Mentor and develop new hires regarding validation techniques and procedures to ensure compliance with defined procedures.
- Represent Technical Operations in cross-functional teams assembled to install, validate, troubleshoot and maintain equipment and processes.
- Participate and support Lean projects and process improvements.
- Designs and drives Quality processes to assure GxP compliance for:
- Disposition of drug substances and investigational medicinal products
- Clinical Study quality audit planning, execution and resolution of issues
- Participates in the planning and content development and review of global regulatory submissions.
- Serves as the Quality representative on project teams and manage relationships with counterparts within Service Provider organizations.
- Designs and oversees the execution of cGXP and SOP training programs.
- Develops quality management budget and monitor expenditures.
- Provides strategic direction and oversight in the development of the company’s Pharmaceutical Quality Systems.
- Identifies cGXP and other key compliance requirements, and provide leadership in promoting awareness and understanding of global regulatory compliance expectations.
- Develops and maintain centralized system for GXP document and record control, archival, protection and access.
- Edits and approves standard operating procedures (SOPs) proposed from functional areas. Assure harmony across all SOPs, and shared responsibilities at functional interfaces.
- Assures proper Service Provider qualification (and disqualification).
- Leads the Internal Audit Program process, including assessment of internal and external (or outsourced) cGXP operations.
- Provides leadership across cross-functional areas, and ensure that drug development activities are conducted and data are generated, documented, reported and maintained in compliance with cGXP requirements.
- Makes recommendations for improvement of product quality and quality system efficiency.
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Engineering Services (Laboratory and manufacturing Equipment):
- Calibration Consultancy
- Development of Calibration Procedures
- Calibration Data Entry
- Completion of Calibration Forms
- Development of PM Procedures
- PM Documentation Data Entry
- Completion of PM Forms
- Commissioning Plan
- Commissioning Protocols
- Sub-Contractors Management
- Schedule Development and Maintenance
- Cost Control and Inventory Management
Test Equipment Rental
- Data Loggers
- Volt meters
Temperature Mapping Services:
- Protocol development
- Trial execution
- Data analysis
Temperature Mapping Equipment List:
- Freezers, Ultra Low Freezers, and Control Rate Freezers
- Cold Rooms
- Stability Rooms
- Stability Chambers
- Warehouse Storage Facilities
Laboratory and Manufacturing Equipment Maintenace/Repairs/Troubleshooting
Laboratory and Manufacturing Equipment List:
- HPLC Systems (with UV, PDA, and IC and RI Detectors)
- GC Computerized Systems(all types)
- UV/Infrared Spectrophotometers
- Multiple Dissolution Stations with Auto Sampler (USP Apparatus I, II, and III)
- Various pH meters, hardness testers, friabilitors, and torque testers (Tablet Micrometers)
- Disintegration baths
- Tap density testers
- Fluid bed processors
- High Shear Granulators/Blenders(all types)
- Planetary Mixers
- Tablet press/tooling(s)
- Various semiautomatic compression and encapsulation machines
- Various granulation and compounding equipment
- Pharmaceutical Metal Detectors
- Induction Cap Sealing Machines
- Manufacturing and Laboratory Ovens
- And many more!