Validation Lead

Urgent Requirement for Validation Lead

Location : KL

Duration : 12 Months(Ext)

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.

3In this role, you will be responsible for:Validation Lifecycle OwnershipLead 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 EvidenceEnsure 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.

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.

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