Compliance Officer
Core
Administers and maintains Quality Systems at a Production Unit from a FDA and global perspective, leading teams to identify and correct cGMP inadequacies and ensure Regulatory Audit readiness.
Role type
Senior Compliance Officer (Pharmaceutical Manufacturing)
Builds
Quality Systems, CAPA system, Site Master File, Annual Product Quality Reviews
Domain
Pharmaceutical manufacturing / Regulatory Compliance
Required skills
cGMP knowledge, FDA guidelines, EU/GLP regulations, Deviation investigations, Complaint handling, Root cause analysis, Risk assessment, Documentation review, Project management
Preferred skills
Problem solving, Attention to detail, Interpersonal communication, MS Office proficiency
Technologies
MS Office (Word, Excel)
Responsibilities
Serve as SME for internal and external audits; Coordinate Regulatory Requests; Complete Complaint and Event Investigations; Lead internal audit teams to remediate noncompliance; Maintain Site Master File; Support Annual Product Quality Reviews; Ensure project deadlines and compliance documentation.
Seniority
Mid-Senior, hands-on IC
