Deviation Specialist II
Core
Conducting thorough investigations and root cause analysis for deviations from SOPs and quality standards in a high-volume sterile manufacturing facility.
Role type
Deviation Specialist (Quality & Compliance)
Builds
Corrective and preventive actions (CAPAs) and deviation reports for management and regulatory authorities
Domain
Pharmaceuticals / Sterile Manufacturing / cGMP
Deliverable
client delivery
Required skills
Deviation management, Root cause analysis, Technical writing, Regulatory knowledge, CAPA implementation, Trend analysis
Preferred skills
Six Sigma, Electronic documentation systems, Biologics experience, Aseptic processing knowledge, GMP/GLP familiarity
Technologies
Microsoft Suite (Word, Excel, PowerPoint)
Responsibilities
Identify and document deviations from SOPs and regulatory guidelines; Conduct investigations to determine root causes; Collaborate on CAPA development and implementation; Maintain accurate records of deviations and investigations; Prepare deviation reports for management and regulators; Participate in internal and external audits; Analyze deviation trends for continuous improvement.
Seniority
Mid-level IC