- Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems.
- Author validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e., 21 CFR Part 11, Annex 11, GxP, local and corporate policies).
- Review and (remote) execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP 5 guidelines and regulations.
- Understands how aspects of data integrity, security, access, and safety are addressed through the various protocols.
- Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols.
- Assist investigate and resolve Deviations, CAPA investigations and other potential issues.
- Develops validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
- Available to attend meetings as necessary
- Periodic Review activities
- Ability to manage three to four active projects
- MODA (EM/ES)
- SAP
- ProcessPad
- ASCTrac
- LIMS
- BMRAM
- ELN
- ComplianceWire
- Adobe sign
- ETQ (reliance)
- Waters/Empower
- Rees
- OSI PI
- Softmax Pro
- Protégé
- Unicorn
- Cytoflex
- Lyrics
- BMS
- Jira
- Minimum of +7 years in the FDA regulated industry.
- 5+ years Document Authoring experience, SOP revisioning experience and re-executing protocols
- Working knowledge of 21 CFR Part 11 and Annex 11.
- Ability to work on multiple concurrent project initiatives.
- Experience in validating Enterprise systems (both on premise and cloud). Examples are SAP, Empower, Labware, Veeva.
- Worked with different validation models from V-Model to CSA.
- 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, to be assertive, to lead by example and to build high-quality relationships.
- Highly flexible, adapting to changes in priorities, requirements and processes is required.
- BS/BA required in a related field.
- 5+ years minimum required relevant experience.
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Computer System Validation Specialist - Durham, United States - RCM Technologies, Inc. | Life Sciences & IT
Description
Job Title: Senior Computer System Validation (CSV) SpecialistJob Function: Computer Software Validation
Job Type: Full Time Contract
Location: Remote
Primary Responsibilities
RCM Life Sciences & IT is a leading provider of Engineering and IT Business Solutions Services to over 1,000 clients in the commercial and government sectors. RCM partners 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 & PR.
Equal Opportunity Statement
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
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