Engr 3, Quality

Must Have21 CFR Part 210/211BS in scientific/technical field (or equivalent experience)Direct CAPA authoringInvestigation writingPharmaceutical/Drug ManufacturingTechnical ReviewNice To HaveCleaning ValidationsEquipment Validation, Transfer, and QualificationICH Q9OOS InvestigationsSupplier AssuranceRole:RequirementsGMP professional to support CAPA deliverables as part of a broader quality remediation initiative, bringing strong knowledge of 21 CFR Part 211 requirements and demonstrated expertise in technical writing and document review within a regulated environment. The ideal candidate will be capable of independently driving high-quality, inspection-ready outputs while partnering with cross-functional teams and contributing to a risk-based approach to compliance, with additional value placed on familiarity with ICH Q9 principles — key capabilities include:Develop and execute CAPA records, ensuring alignment with regulatory expectations and internal quality standardsPerform thorough technical writing and critical review of investigations, protocols, and reportsApply 21 CFR Part 211 knowledge to ensure GMP compliance across deliverables and identify potential risks or gapsCollaborate with SMEs and functional teams to drive timely closure of CAPAs and maintain project timelinesAdditional desired skills in risk assessment and risk management to contribute to or author/review risk assessments using a structured, science- and risk-based approach (ICH Q9 experience preferred)