Validation Supervisor
Detail posisi
Kewajiban
• Follow up Include individual validation plan of the following but not limited to:-
• Process (GMP) validation
• Process (Product) validation
• Facilities validation
• Cleaning validation
• System, Utility and Equipment Qualification
• Analytical method validation
• Computerized system validation
• Follow up with concerned department to perform all validation according to the set up validation master plan.
• Follow up equipment qualification of new equipment and major change of existing equipment.
• Establish cleaning validation protocol and conclusion of critical manufacturing equipment.
• Follow up facility validation of new facility and major change of existing facility.
• Follow up validation document from concerned department.
• Keep and control validation document.
• Prepare and update concerned document: work instruction, Quality procedure, etc.
• Co-ordinate for validation activities of new manufacturing equipment, system, utility and facility project to guide and conduct validation & qualification plan.
• Follow up and report the environmental monitoring program is state and effectively carried out (water, air, personal hygiene) as per the plan.
• Prepare validation document, work instructions, validation procedure and related documents.
• Prepare validation master plan.
• Review validation protocols, validation report, calibration reports.
• Develops and implement validation training program.
• Ensures that the validation systems cost effective.
• Enforces company polices on CGMP discipline and safety.
Kualifikasi
• Bachelor degree in Pharmacy
• Experience min 3-5 years