PharmaLex is looking to expand its Quality Assurance consulting network!
Although qualifications will vary depending on the specific project, in general clients are looking to engage Quality Assurance Managers or Directors with at least 5 – 10 years of experience working in a regulated FDA environment.
- At least 5-10 years direct expertise working within the pharmaceutical, biotech, or medical device industry (required for all positions)
· Hands-on experience with quality management system (i.e. training, metrics, documentation management)
· Robust understanding of change control principles and work flow
· Strong background on Deviations, Root Cause Analysis (RCA) and Corrective Action Preventative Action (CAPA) management
· Familiarity with documentation control practices, including writing and revision of policies, SOPs and work instructions
· Batch records review and approval for clinical and commercial products
· Compliance review experience (i.e. laboratory data review, product release)
· Aptitude for increasing efficiencies and improving processes
· Auditing experience preferred
·Experience with QMS and/or EDMS / QMS software preferred (i.e. Trackwise, MasterControl, Veeva Vault, etc)
· Massachusetts: Waltham/ Watertown/ Boston / Cambridge and surrounding areas