QA Compliance Associate
Location: New Brunswick
Posted on: November 18, 2022
Responsible for QMS Track wise module related to Laboratory,
Investigation Review Board and Quality Review
-Review of all investigations related to QC Lab and CFT
-Ensure investigations are properly reviewed with respect to root
cause, CAPA requirements and their evaluation.
-Conduct IRB & QRB meetings as per schedule.
-Create database for all IRB and QRB meeting information; track
action items and ensure the actions are completed.
-Track all overdue records impacting the QRB Site Quality
-As per schedule generate IRB & QRB reports and submit on a timely
basis to Corporate Function.
-Develop an action plan for investigation improvements and Site
-Work closely on all projects under 21s -t -Centur -y Quality
-Create prog -ress report on all projects under 21s -t -Cent -ury
-Provide information for product assessment report, analytical life
cycle activity and QMMR.
-Review product related changes, if any.
-Review Track wise records for QA related activities such as UPD /
Lab event / OOS / OOT / change control / CAPA and verification of
-Investigation certification module for the site, provide data for
Investigation effectiveness checks.
-Investigation effectiveness check.
-Work as 21s -t -Century Quality program lead (Center of Excellence
-Analytical methods and specification review in DCM and SOP review
Working in Manufacturing Environment, Laboratory Environment
Edu -cation and Job Qualification
-Minimum of Bachelor's degree.
-Excellent interpersonal and communication, both written and
-Strong organizational and time management skills; must be ab -le
to pr -ioritize and manage multiple assignments simultaneously
while working independently or with others as needed.
-A self-starter with a hands-on approach and a can-do attitude.
-The requirement for English language proficiency for this job role
is Intermediate-B1+ (comparable to Global
CEFR Independent B1) level based on the Common European Framework
of Reference for Languages (CEFR).
-Minimum of eight (8) years of experience within the pharmaceutical
industry in quality function role.
-Experience working in an international multicultural matrix
Keywords: Kaztronix, New Brunswick , QA Compliance Associate, Other , New Brunswick, New Jersey
Didn't find what you're looking for? Search again!