Assistant Officer – Quality & Regulatory Affairs

Responsibilities

• Assist to perform and maintain QA activities and records for product release, product return and repackaging to ensure the compliance of GMP, GDP, and regulatory requirements
• Assist to coordinate and execute process validation; prepare documentations, policy, protocol and report
• Assist in establishing and maintaining quality management system and an efficient pharmacovigilance system in compliance with the local authority’s regulation and Regional PV policies & SOPs
• Provide support in the GMP (repackaging) operation including incoming materials inspection, in process control and finish product sampling
• Support regulatory affairs / product registration related activities
• Process documentation of corrective actions plans and monitors implementation;
• Participate ad hoc project as assigned

Requirements