Compliance Specialist

Scope of Compliance team:

• Internal audit & External inspections
• Site Inspection Readiness
• Regulatory submission
• Site Quality Metrics and Management review
• Quality Plan (Improvement projects)
• Quality Risk Management
• Data Integrity

Main responsibility/scope for Candidate:

1. Conduct training for data integrity (site wide refresher and NEO hire training) and review documents related to Data Integrity (Audit trail review, and Data Integrity Risk assessment etc)
2. Conduct internal audits and support internal audit CAPAs follow-up (discussion of response) and management of open audit CAPAs
3. Serve as Compliance Partner for inspection readiness for assigned department
4. Support external inspections (logistics and backroom support)
5. Support for other areas (Quality risk management, Quality Plan, QMR tasks and regulatory submission) in terms of management of open tasks, revision/routing of documents

Criteria:

• At least 6 years QA experience in GMP manufacturing operations (API/Bio manufacturing) required, preferably in Quality Operations/Compliance
• Experience in internal audit and external inspection preferred
• Knowledge in Data integrity and Data governance principles required
• Strong knowledge in Engineering operations, OT and IT systems (DeltaV, MES system, SAP, LIMS etc) and system interface preferred
• Quality and Compliance mindset required
• High adaptability and ability to lead and work with cross functional team required
• Strong communication and writing skills required
• Team player required