Quality Validation Officer - CSV In Pharmaceutical (1 Year Contract) - Part-Time

Job Description & Requirements

Job Purpose

To ensure manufacturing facilities, processes, analytical methods, and systems are validated in compliance with cGMP and regulatory requirements, ensuring consistent product quality in accordance with established specifications.

Key Responsibilities

• Participate in and/or lead GMP audits of equipment, systems, processes, and cross-functional departments

• Prepare, review, and maintain validation-related SOPs, policies, and procedures

• Assess and approve changes (Change Control) that may impact product quality, compliance, or validation status

• Review, approve, and authorize validation protocols and reports

• Support and participate in internal, corporate, and regulatory audits as a validation SME

• Conduct investigations related to complaints, deviations, recalls, or failures; assess root causes and CAPA impact on validation

• Act as Validation Coordinator for projects with product quality impact, including chairing validation meetings

• Provide QA support for New Product Introduction (NPI) to ensure GMP compliance

• Lead and manage Cleaning Validation activities

• Perform periodic validation reviews, recommend re-validation when required, and approve Continued Process Verification (CPV) documents

• Support and coordinate Method Validation activities, where applicable

• Provide quality oversight on engineering compliance, including PM deviations, data management, and GxP spare parts/consumables

Technical & Professional Skills

• Strong knowledge of GMP, Computer System Validation and validation principles

• Good understanding of manufacturing and quality systems

• Familiarity with regulatory requirements and audit processes

• Good audit, documentation, and investigation skills

• Basic understanding of corporate quality management systems
  

  To find out more about this opportunity, please contact Dianna at [email protected].

  We regret that only shortlisted candidates will be notified.

  GMP Technologies (S) Pte Ltd | EA License: 11C3793 | EA Personnel: Dianna| Registration No: R1327268