Quality Assurance Associate
Edison-New Brunswick Metro Area, NJ
The QA Associate is responsible for ensuring compliance with GVP, regulations and established procedures. They support the review of PV data (ICSRs, PSRs etc.) and utilize Quality Assurance databases and review documentation for compliance with GVP, FDA, ICH and other regulatory requirements and perform administrative tasks. Experience: Minimum experience of 5 years in local or global Pharmacovigilance activities including case processing.
Understanding of Pharmacovigilance processes, PV database system, Dictionaries required
Quality management experience required: (e.g. previous QA role, inspections and/or audits, experience with performing RCAs, corrective action plan (CAPA methodology) definition and implementation or Lean/ Six Sigma methodologies)
Demonstrated knowledge of international regulations and guidelines like: International Conference on Harmonization (ICH), Council for International Organizations of Medical Sciences (CIOMS), European Medicines Agency (EMEA)/ Food and Drug Administration (FDA)
Bachelor s degree in life sciences or related field required; certified health professional degree preferred but not required (example Pharmacist, Pharm D or Bachelor of nursing degree)