What are the responsibilities and job description for the Senior Auditor position at Vastika Inc?
Skills: GCP Sr. Auditor, GCP, Auditor, Pharmaceutical, Audits, SOPs, QMS, GXP QA audit programs, GXP Compliance, GXP, Clinical Vendor Audits, SMEs (IRT, EDC etc.), FDA regs, Regulations, Biopharmaceutical, Safety Pharmacovigilance, Clinical Development
Must have:
- Bachelor’s degree in a scientific, health care, or related discipline.
- Minimum 5 years of experience in the pharmaceutical
- The ideal candidate will have extensive GCP experience.
- Proven experience conducting and managing internal and external GXP audits, including clinical development and safety/pharmacovigilance audits.
- GCP guidelines and global regulatory requirements (e.g., FDA, EMA, ICH GCP).
- auditing CROs, CMOs, investigator sites, and clinical vendors.
- clinical systems such as IRT and EDC from an audit perspective.
- Familiarity with Quality Management Systems (QMS), SOPs, and compliance documentation.
Nice to have:
- Prior experience in a biopharmaceutical company focused on neurology or psychiatry therapies.
