What are the responsibilities and job description for the CSV-Validation/(Good Clinical Practice) position at Anveta Inc?
This position involves validation strategy and planning, executing, and qualification of computer systems and/or infrastructure components in accordance with applicable policies, procedures, and regulatory requirements.
Responsibilities:
- Define validation strategy for computerized systems and platforms utilized in GxP Space
- Create validation deliverables such as Validation Plan, Test Protocols, Traceability matrix, and execution of protocols
- Participate in user review meetings, discussions with Quality Assurance and Compliance groups
- Participate/conduct Risk Assessments
- Develop and maintain policies and procedures
- Effectively communicate the validation activities and deliverables to the project team, customer stakeholders, and global team within Zifo
- Act as a liaison between Zifo remote teams and customers in US & Canada
- Participate in internal initiatives around Computer Systems Validation
Requirements:
Qualifications
- Bachelor or Master''''''''s degree in Life Sciences or Computer Sciences
- 7-10 years'''''''' experience with Computer Systems Validation is required for this role
- Strong knowledge of GxP Requirements, Google Cloud Platform regulations, 21 CFR part 11 requirements
- Must have experience with validation of IT infrastructure systems including R, SAS, etc.
- Experience with GxP systems validation like ELN, LIMS, QMS, etc.
- Experience with Veeva Vault Systems
- Clinical experience is a must