- Kuala Lumpur Federal Territory Malaysia
Kerja Sepenuh Masa, Validation Lead di Accenture Southeast Asia Federal Territory - Maukerja
Kongsi
Simpan
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
About the Role As a Validation Lead within Pharma TechOps, you will play a critical role in ensuring that the digital systems supporting Pharma Technical Development (PTD) meet the highest standards of quality, regulatory compliance, and patient safety. You will serve as the validation subject matter expert across a portfolio of GMP-critical systems, owning the end-to-end validation lifecycle and ensuring systems remain compliant, audit-ready, and fit for purpose throughout their lifecycle.3 In this role, you will be responsible for: Validation Lifecycle Ownership Lead end-to-end Computer System Validation (CSV) and Computer System Assurance (CSA) activities for GMP-critical systems, including validation planning, protocol development, execution oversight, report approval, and lifecycle management. Ensure systems are validated, maintained, and remain audit-ready throughout their lifecycle. Risk-Based Validation Apply risk-based validation principles to determine appropriate validation strategies, deliverables, and testing approaches based on system GxP classification, business criticality, and regulatory impact. Lead and facilitate system and functional risk assessments to define validation scope, testing requirements, and compliance controls. Validation Documentation & Compliance Evidence Ensure validation deliverables, records, evidence packages, system histories, compliance documentation, and deliverable registries are complete, traceable, maintained, and aligned with applicable procedures and regulatory expectations. Knowledge Transfer & Transition Support Ensure validation documentation, compliance records, and system histories are properly captured and transitioned during system handovers, organizational changes, and service transitions to maintain continuity of the validated state. Qualifications & Experience Bachelor's degree or equivalent in Computer Science, Software Engineering, Information Systems, Life Sciences, Engineering, or a related discipline. Minimum 5 years of experience in IT and software validation (CSV, CSA, GAMP) within the pharmaceutical, biotechnology, life sciences, or other regulated industries. Proven experience leading validation activities across GMP-regulated computerized systems throughout implementation, maintenance, enhancement, and retirement phases. Experience authoring validation plans, validation reports, risk assessments, and reviewing validation deliverables, records, and supporting evidence. Strong understanding of Software Development Lifecycle (SDLC) methodologies and validation practices within regulated environments. Experience working with Agile, Scrum, SAFe, Lean, or similar delivery methodologies. Experience supporting applications subject to global regulatory requirements and inspections. Technical & Regulatory Knowledge Strong knowledge of GxP regulations and industry standards, including GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and applicable computerized system validation and assurance guidance. Solid understanding of risk assessment methodologies, data integrity principles, and computerized system lifecycle management. Awareness of modern software development technologies, cloud-based solutions, and governance processes impacting validation strategies and approaches. Skills & Competencies Ability to independently lead validation workstreams across multiple systems and projects simultaneously. Strong analytical, problem-solving, and decision-making capabilities related to quality and technical compliance matters. Excellent written and verbal communication skills with fluency in English. Strong stakeholder management, leadership, coaching, and conflict resolution skills. Ability to collaborate effectively within global, cross-functional, and multicultural teams. Demonstrated ability to share knowledge, mentor colleagues, and drive continuous improvement initiatives.
About The Role
As a Validation Lead within Pharma TechOps, you will play a critical role in ensuring that the digital systems supporting Pharma Technical Development (PTD) meet the highest standards of quality, regulatory compliance, and patient safety. You will serve as the validation subject matter expert across a portfolio of GMP-critical systems, owning the end-to-end validation lifecycle and ensuring systems remain compliant, audit-ready, and fit for purpose throughout their lifecycle.3
In this role, you will be responsible for:
Validation Lifecycle Ownership
Lead end-to-end Computer System Validation (CSV) and Computer System Assurance (CSA) activities for GMP-critical systems, including validation planning, protocol development, execution oversight, report approval, and lifecycle management. Ensure systems are validated, maintained, and remain audit-ready throughout their lifecycle.
Risk-Based Validation
Apply risk-based validation principles to determine appropriate validation strategies, deliverables, and testing approaches based on system GxP classification, business criticality, and regulatory impact. Lead and facilitate system and functional risk assessments to define validation scope, testing requirements, and compliance controls.
Validation Documentation & Compliance Evidence
Ensure validation deliverables, records, evidence packages, system histories, compliance documentation, and deliverable registries are complete, traceable, maintained, and aligned with applicable procedures and regulatory expectations.
Knowledge Transfer & Transition Support
Ensure validation documentation, compliance records, and system histories are properly captured and transitioned during system handovers, organizational changes, and service transitions to maintain continuity of the validated state.
Qualifications & Experience
Bachelor's degree or equivalent in Computer Science, Software Engineering, Information Systems, Life Sciences, Engineering, or a related discipline.
Minimum 5 years of experience in IT and software validation (CSV, CSA, GAMP) within the pharmaceutical, biotechnology, life sciences, or other regulated industries.
Proven experience leading validation activities across GMP-regulated computerized systems throughout implementation, maintenance, enhancement, and retirement phases.
Experience authoring validation plans, validation reports, risk assessments, and reviewing validation deliverables, records, and supporting evidence.
Strong understanding of Software Development Lifecycle (SDLC) methodologies and validation practices within regulated environments.
Experience working with Agile, Scrum, SAFe, Lean, or similar delivery methodologies.
Experience supporting applications subject to global regulatory requirements and inspections.
Technical & Regulatory Knowledge
Strong knowledge of GxP regulations and industry standards, including GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and applicable computerized system validation and assurance guidance.
Solid understanding of risk assessment methodologies, data integrity principles, and computerized system lifecycle management.
Awareness of modern software development technologies, cloud-based solutions, and governance processes impacting validation strategies and approaches.
Skills & Competencies
Ability to independently lead validation workstreams across multiple systems and projects simultaneously.
Strong analytical, problem-solving, and decision-making capabilities related to quality and technical compliance matters.
Excellent written and verbal communication skills with fluency in English.
Strong stakeholder management, leadership, coaching, and conflict resolution skills.
Ability to collaborate effectively within global, cross-functional, and multicultural teams.
Demonstrated ability to share knowledge, mentor colleagues, and drive continuous improvement initiatives.
About The Role
As a Validation Lead within Pharma TechOps, you will play a critical role in ensuring that the digital systems supporting Pharma Technical Development (PTD) meet the highest standards of quality, regulatory compliance, and patient safety. You will serve as the validation subject matter expert across a portfolio of GMP-critical systems, owning the end-to-end validation lifecycle and ensuring systems remain compliant, audit-ready, and fit for purpose throughout their lifecycle.3
In this role, you will be responsible for:
Validation Lifecycle Ownership
Lead end-to-end Computer System Validation (CSV) and Computer System Assurance (CSA) activities for GMP-critical systems, including validation planning, protocol development, execution oversight, report approval, and lifecycle management. Ensure systems are validated, maintained, and remain audit-ready throughout their lifecycle.
Risk-Based Validation
Apply risk-based validation principles to determine appropriate validation strategies, deliverables, and testing approaches based on system GxP classification, business criticality, and regulatory impact. Lead and facilitate system and functional risk assessments to define validation scope, testing requirements, and compliance controls.
Validation Documentation & Compliance Evidence
Ensure validation deliverables, records, evidence packages, system histories, compliance documentation, and deliverable registries are complete, traceable, maintained, and aligned with applicable procedures and regulatory expectations.
Knowledge Transfer & Transition Support
Ensure validation documentation, compliance records, and system histories are properly captured and transitioned during system handovers, organizational changes, and service transitions to maintain continuity of the validated state.
Qualifications & Experience
Bachelor's degree or equivalent in Computer Science, Software Engineering, Information Systems, Life Sciences, Engineering, or a related discipline.
Minimum 5 years of experience in IT and software validation (CSV, CSA, GAMP) within the pharmaceutical, biotechnology, life sciences, or other regulated industries.
Proven experience leading validation activities across GMP-regulated computerized systems throughout implementation, maintenance, enhancement, and retirement phases.
Experience authoring validation plans, validation reports, risk assessments, and reviewing validation deliverables, records, and supporting evidence.
Strong understanding of Software Development Lifecycle (SDLC) methodologies and validation practices within regulated environments.
Experience working with Agile, Scrum, SAFe, Lean, or similar delivery methodologies.
Experience supporting applications subject to global regulatory requirements and inspections.
Technical & Regulatory Knowledge
Strong knowledge of GxP regulations and industry standards, including GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and applicable computerized system validation and assurance guidance.
Solid understanding of risk assessment methodologies, data integrity principles, and computerized system lifecycle management.
Awareness of modern software development technologies, cloud-based solutions, and governance processes impacting validation strategies and approaches.
Skills & Competencies
Ability to independently lead validation workstreams across multiple systems and projects simultaneously.
Strong analytical, problem-solving, and decision-making capabilities related to quality and technical compliance matters.
Excellent written and verbal communication skills with fluency in English.
Strong stakeholder management, leadership, coaching, and conflict resolution skills.
Ability to collaborate effectively within global, cross-functional, and multicultural teams.
Demonstrated ability to share knowledge, mentor colleagues, and drive continuous improvement initiatives.
Peringatan Penting
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