Validator

In this role, the Validator is responsible for maintaining a high level of quality assurance by rigorously applying validation protocols and methodologies, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing. The position demands meticulous review of compliance documentation and the ability to implement corrective actions effectively using root cause analysis techniques such as Fishbone Diagram Analysis and the 5 Whys methodology. Familiarity with compliance and regulatory frameworks, alongside expertise in validation lifecycle management tools and audit trail reviews, contributes to successful validation outcomes. With at least two years of experience and strong product knowledge, the Validator ensures seamless closure of validation activities in alignment with organizational goals, without managing a team.
Responsibilities

Conduct comprehensive validation activities including IQ, OQ, and PQ testing to ensure products and systems comply with regulatory standards and quality protocols.
Perform detailed audit preparation and compliance monitoring to maintain adherence to internal and external regulatory requirements such as FDA 21 CFR Part 11 and GxP.
Manage and review validation documentation, ensuring accuracy and compliance across audit trails, quality management systems, and document control processes.
Apply risk-based validation planning techniques, including Failure Modes and Effects Analysis (FMEA), to identify potential risks and devise mitigation strategies.
Utilize root cause analysis tools such as Fishbone Diagram and 5 Whys methodology to investigate and resolve defects or non-compliance issues efficiently.
Support process improvement initiatives by leveraging Six Sigma, Lean methodologies, and Good Manufacturing Practice (GMP) compliance requirements.
Maintain and operate compliance monitoring software, defect tracking tools, and electronic records and signatures validation systems.
Collaborate with stakeholders to ensure timely closure of validation deliverables, aligning with product knowledge and project objectives.
Implement and maintain validation lifecycle management tools in accordance with GAMP 5 methodology and validation master plans.
Ensure thorough audit trail reviews and validation protocol adherence to facilitate regulatory inspections and quality assurance audits.
Document and track issues using issue management systems, promoting transparency, traceability, and continuous improvement within validation processes.
Stay up-to-date with the latest regulatory frameworks, validation standards, and technological advancements such as blockchain technology and cryptographic hashing to enhance validation practices.