Quality Validation Officer - CSV in pharmaceutical (1 year Contract)
GMP TECHNOLOGIES (S) PTE LTD
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_hidden***.
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA License: 11C3793 | EA Personnel: Dianna| Registration No: R1327268
