Senior Computer Systems Validation Consultant
3 weeks ago
RCM Life Sciences and IT;RCM Technologies is seeking a highly skilled Senior Computer Systems Validation Consultant to join our team. As a key member of our validation team, you will be responsible for leading computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems.
Key Responsibilities:- Lead computer system validation projects, ensuring compliance with relevant regulations (21 CFR Part 11, Annex 11, GxP, local and corporate policies)
- Author validation protocols to ensure technology solutions are compliant with regulations
- Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines, cGMP, and ISPE GAMP 5 guidelines and regulations
- Understand data integrity, security, access, and safety aspects addressed through protocols
- Write risk assessments according to GMP and 21 CFR Part 11 compliance guidelines
- Prepare validation summary reports for executed protocols
- Assist in investigating and resolving deviations, CAPA investigations, and other potential issues
- Develop validation deliverables, such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, and Change Controls
- Validate software for Laboratory and Manufacturing instruments
- Minimum 7 years of experience in the FDA-regulated industry
- 5 years of document authoring experience, SOP revisioning experience, and re-executing protocols
- Working knowledge of GMP, 21 CFR Part 11, and Annex 11
- Ability to work on multiple concurrent project initiatives
- Experience with Laboratory and Manufacturing Instrument Software Validation
- Experience in validating Enterprise systems (on-premise and cloud)
- Examples include SAP, Empower, Labware, Veeva
- Ability to apply Agile and Waterfall methodology
- Excellent written and verbal communication skills
- Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues
- Strong collaboration with colleagues at all levels
- Strong customer service and teamwork-oriented
- Ability to take initiative, lead by example, and build high-quality relationships
- French language proficiency is a plus
RCM Life Sciences and IT;RCM Technologies is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. We partner with clients to define, implement, and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.
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Senior Computer Systems Validation Consultant
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Durham, North Carolina, United States RCM Life Sciences and IT;RCM Technologies Full timeJob Title: Senior Computer Systems Validation ConsultantWe are seeking a highly skilled Senior Computer Systems Validation Consultant to join our team at RCM Life Sciences and IT; RCM Technologies. As a Senior Computer Systems Validation Consultant, you will be responsible for leading computer system validation projects related to authoring and executing...
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Senior Computer Systems Validation Consultant
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Durham, North Carolina, United States RCM Life Sciences and IT;RCM Technologies Full timeJob Title: Senior Computer Systems Validation ConsultantWe are seeking a highly skilled Senior Computer Systems Validation Consultant to join our team at RCM Life Sciences and IT;RCM Technologies. As a key member of our team, you will be responsible for leading computer system validation projects related to authoring and executing specifications and...
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