Compliance Specialist
Core
Identify and correct cGMP inadequacies at the Production Unit and develop/implement Quality Systems to maintain audit readiness and Regulatory Compliance.
Role type
QA Compliance Specialist
Builds
Quality Systems for internal/external audit readiness and Regulatory Compliance
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, Annual Product Quality Review (APQR) facilitation, regulatory documentation review, internal audit coordination, document storage and archiving compliance, FDA readiness audit participation
Preferred skills
multi-functional project team collaboration, applying new regulations/guidance documents to site Quality Assurance
Responsibilities
Compile, process, and facilitate the Annual Product Quality Review; ensure adherence to regulatory requirements through documentation review; coordinate compliance initiatives based on new regulations; participate in FDA readiness audits; support event initiation and investigations.
Seniority
Individual Contributor
