5 of 5 Permanent GxP Jobs in the West Midlands

Built-in reporting tools § External tools * Data Analytics o Interpreting lab data and presenting insights Regulatory & Compliance Knowledge (Critical in LIMS) * Understanding of: o GxP (Good Practice standards) o FDA 21 CFR Part 11 o ISO 17025/GMP * Knowledge of: o Electronic signatures o Audit trails o Data validation ...

with organisations operating in highly regulated and complex environments. Your experience in any of the following would be advantageous:Life SciencesPharmaceuticalsBiotechnologyMedical DevicesRegulated ManufacturingExperience with:GxP environments21 CFR Part 11 and EU Annex 11 complianceElectronic records and audit requirementsContract Manufacturing (CMO/CDMO)Batch manufacturing and lot genealogyQuality and release managementCold ...

projects within regulated industries such as Life Sciences, Pharmaceuticals, Chemicals or Manufacturing PRINCE2, PMP, APM PMQ or equivalent Project Management qualification Desirables Knowledge of GxP validation or validated system implementations Experience delivering global software rollouts across multiple sites Commercial awareness with experience managing project financials and contract scope The Company ...

resource planningExperience delivering projects within regulated industries such as Life Sciences, Pharmaceuticals, Chemicals or ManufacturingPRINCE2, PMP, APM PMQ or equivalent Project Management qualificationDesirablesKnowledge of GxP validation or validated system implementationsExperience delivering global software rollouts across multiple sitesCommercial awareness with experience managing project financials and contract scopeThe CompanyYou'll join ...

cloud-based and regulated environments Driving audit readiness, compliance programs and evidence-based assurance across frameworks such as ISO 27001, GDPR, SOC 2 and GxP Providing leadership on risk management, governance and security strategy Partnering with customers, auditors and key stakeholders on security reviews, assurance activities and regulatory compliance Supporting … several of the following areas: Security leadership, governance, risk and compliance (GRC) Cloud security architecture and security strategy ISO 27001, GDPR, SOC 2, GxP, 21 CFR Part 11 or similar regulated frameworks Audit leadership, customer assurance and certification programs Healthcare technology, pharmaceutical, biotechnology or regulated SaaS environments Customer-facing security ...