CSV/ MES Quality Validation
Core
Ensure quality excellence and regulatory compliance across manufacturing operations for pharmaceutical, medical device, or biotech products.
Role type
Senior Quality Engineer (Regulated Industry)
Builds
Robust quality management systems and compliant manufacturing processes
Domain
Life Sciences / Pharmaceutical / Medical Device / Biotech
Deliverable
client delivery
Required skills
CAPA and deviation management, Change control, Risk management and FMEA, Document control, Internal/external auditing, Root cause analysis, Validation and qualification protocols, Statistical analysis, Quality management software
Preferred skills
Engineering or Life Sciences background, ASQ certifications (CQE, CQA)
Responsibilities
Resolve quality issues, conduct risk assessments, manage CAPAs, support audits, implement quality initiatives
Seniority
Senior, hands-on IC
