Job Description

Primary role objective: The role of the Quality Validation Officer is to ensure that the manufacturing facilities, processes, analytical methods and systems are validated in full compliance with curr Primary role objective: The role of the Quality Validation Officer is to ensure that the manufacturing facilities, processes, analytical methods and systems are validated in full compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements so as to meet the stipulated product quality standards of the company. Responsibilities: Participate / lead in the conduct of audits on equipment / system to ensure full GMP and regulatory compliance Draft, compile, review and update appropriate policies and procedures in support of the validation activities on site Assess, review and approve changes that may have an impact on the validation status of the facility, processes or systems on site Review and authorize validation protocol documents and reports Participate as an audit team member and/or as a subject matter expert in the preparation of site audits by internal corporate groups and external regulatory agencies Participate in Continuous Improvement for existing processes Participate in the conduct of investigations relating to customer complaints, returned / recalled goods, investigations of failure, etc to assess root causes of the complaints, and evaluate the impact of corrective actions on the validation status Act as a Validation Co-ordinator in projects that are deemed to have product quality impact, chair the Validation Working Party meetings and lead the conduct of validation activities to ensure that validation / regulatory requirements are met Lead the cleaning validation programme to ensure that all cleaning methods used are validated in compliance with regulatory requirements Take on Validation Co-ordinator role for Method Validation to assess, review and approve changes that may have an impact on the method validation Requirements: Bachelor Degree in Chemical Engineering or equivalent Mininum 2 years of experience in Pharmaceutical industry with GMP background Able to support change control, equipment qualification, lab equipment qualification Familiar with engineering process or API Manufacturing process Analytical mindset and critical thinking Detail-oriented and able to work independently Demonstrate self-motivation with a continuous improvement focus Excellent interpersonal and communication skills Proficient in business report writing Willingness to learn Must be comfortable with Contract basis role