Quality Engineer 3

Roles & ResponsibilitiesDevelop, manage, and execute CAPA records aligned with regulatory and internal quality standards.Perform technical writing and detailed review of investigations, protocols, and reports.Ensure GMP compliance across quality and documentation deliverables.Identify compliance gaps, risks, and improvement opportunities.Collaborate with SMEs and cross-functional teams to support timely CAPA closure.Contribute to risk assessments and risk management activities using a science-based approach.Support inspection-ready documentation and quality processes.Maintain project timelines and deliverables.Experience RequiredExperience in GMP-regulated environments preferred.Strong experience with CAPA processes and quality remediation activities.Experience in technical writing and document review within regulated industries.Familiarity with risk assessment and risk management practices preferred.ICH Q9 experience is an advantage.Skills & CertificationsCAPA managementGMP complianceTechnical writing and document reviewInvestigation and report reviewRisk assessment and risk managementCross-functional collaborationProblem-solving and analytical skillsTime management and organizationEligibilities & qualificationsBachelor's degree in Life Sciences, Pharmacy, Engineering, Quality, or related field preferred.Experience in pharmaceutical, biotech, or regulated manufacturing environments preferred.Ability to work independently and manage multiple deliverables.