What are the responsibilities and job description for the Senior Computer Systems Validation Consultant position at RCM Technologies, Inc. | Life Sciences / Data & Solutions?
Job Description
Job Description
Contract role, 40 hrs / week
Title or Role : Computer System Validation
Compensation : Up to $47 / hour - commensurate with experience
Location : Remote
Length of Contract : 6 months
Primary Responsibilities
- 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.
- Validates software for Laboratory and Manufacturing instruments.
- Available to attend meetings as necessary
- Periodic Review activities
- Ability to manage three to four active projects
Qualifications
Education
Equal Opportunity Statement :
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Pay Transparency :
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.
Disclaimer :
This job posting is intended to describe the general nature and the level of the work to be performed. 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.
About RCM :
RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. 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.
Salary : $47