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Our division M & R Pharma specializes in technology services for the life sciences
industry providing validation expertise, process design, control systems,
software development, and database services.
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| Breadth of knowledge and diversity of technical expertise |
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- Highly skilled technical staff who keeps up-to-date with regulatory compliance, industry guidelines and technology
- Over 200 employed software engineers
- Resource of 11,000 subcontract engineers
- Minimum of 5 years experience
- Nationwide, Headquartered in Burlington, MA
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| M & R’s Pharma consulting division provides technical engineers to the pharmaceutical and life science industry |
| Our engineers have expertise in: |
- Process and control system design and validation testing
- Software Quality Assurance utilizing System Development Life Cycle Methodology
- Validation protocols and regulations, cGMPs and 21CFR Part 11
- CRF Part 11 Gap Analysis and Remediation Compliance
- Computer System Validation Lifecycle
- Develop Installation, Operational and Performance Qualification protocol
- Compliance audits, master planning, risk analysis, quality assurance plans, requirements documents, specifications, commissioning, installation qualification (IQ), operational qualification (OQ), standard operating procedures (SOP), and final report writing
- Clinical Trials databases, Process Control Systems, SAS, PLC’s (Allen Bradley), SCADA (Wonderware, Intellution, Delta V), DCS, MRP II, MES, ERP (SAP, Oracle, Peoplesoft, JD Edwards) and/or LIMS systems (such as, Applied Biosystems, Beckman Labware, and Perkin Elmer)
- IQ/OQ/PQ and SOP development and execution for analytical instruments and associated tests
- Multiplatform: Unix, Sun, IBM 390, RS6000, AS400, Microsoft
- Multiple Databases: DB2, Oracle, SQL, Sybase, Progress, Informix, FoxPro, Access
- Custom software programming and systems integration
- Cleaning Validation, Process Validation, Computer Validation, SIP/CIP Validation
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| Contract on an as-needed basis, short or long term projects |
- IT outsourcing or projects
- Data migration, administration, analysis
- Application and database implementations, migrations, upgrades
- Customization, systems integration, ERP, CRM services
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