Responsibilities

This role involves documenting deviations, including root cause analysis, corrective actions, and preventive measures; drafting and managing change control records to ensure changes align with GMP standards; producing clear and concise technical documents such as SOPs, work instructions, and reports; collaborating with production, quality, and engineering teams to gather information and ensure accurate documentation; supporting continuous improvement initiatives; training and guiding staff on deviation and change control procedures; supporting audits by providing documentation and resolving findings related to deviations and change management; adhering to general cGMP rules, Quality policies, procedures and instruction; and actively contributing to safety initiatives and issues, as well as near miss reporting and follow-up.