• Managing the preparation, routing, review, approval, distribution, and archival of new and revised controlled procedures and protocols.
• Monitoring, improving and maintaining to ensure compliance documents with GXP.
• Performing and assisting with qualification and validation activities.
• Handling calibration activities.
• Handling deviations, non-conformities, CAPA, change control, QRM and complaints.
• Reviewing batch records.
• Trending and reporting batch review and QMS data.
• Assisting in the execution and improvement of regulatory processes.
• Handling PQR, PSUR and PMQC.
Requirements
• Minimum Bachelor’s degree of related education and experience.
• Minimum 2 years Quality Assurance experience in the pharmaceutical industry.
• Good knowledge of Pharmaceutical Quality System.
• Good knowledge of English.
• Possess excellent computer (MS office: word; excel; access; outlook and etc.), writing and editing skills.
• Effective time management and interpersonal skills.
• Strong communication skills.