What are the responsibilities and job description for the Auditor - Pharmaceutical industry position at AdeptSource?
Pharmaceutical Auditor
Seeking a local Auditor with experience in Pharma who is located in the SF Bay area.
Scope of systems and processes to audit:
This audit will be done in January 2024.
Will be Auditing our client's SDLC implementation and V&V of software used during Assay Execution (LDT used for analysis). Auditing of medical device software will be done against ISO 13485, IEC 62304; and also auditing non-medical device software for compliance to the CSV SOP (ISO 13485, Part 820.70(i) & 21 CFR Part 11). Scope includes software Validation, design controls, 820.70i (production & process controls). Scope also includes upstream software applications (e.g. snowflake, sfdc, etc.) that are interfacing with lab software.
- Must be able to WORK INDEPENDENTLY with minimal engagement from company staff.
- Most work can be done remotely but some time on-site will be required.
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