Sterile Production Supervisor

Job Description

Job Responsibilities:

• Supervise technician activities
• Supervise production pharmacist & production chemist & seniors activities
• Prepares operational schedules and coordinates manufacturing activities
• Monitors the production processes and its conformance to regulations and identifies any deviation and trend.
• Ensures that plant facilities , utilities ,equipments are maintained well to meet production plan
• Maintain batch record & relevant documents to ensure that all production steps are performed correctly, signed by production staff & QA member.
• Prepare plan for process validation cleaning validation & execute the validation plan in coordination with validation team.
• Ensure that all rules & regulation regarding GMP are followed.
• Monitors safety programs to eliminate industrial accidents.
• Documents procedures used to assemble; process and test company's products.
• Monitors effectiveness of production process and determines any necessary changes to processes, equipment to support the production activity.
• Supervise Preparation, filtration & autoclaving processes.
• Follow up integrity testing for used filters according to authorized SOP.
• Follow up availability of primary packaging materials for filling machine.
• Follow-up cleaning and fumigation of sterile area.
• Monitoring of RH%, Temp., and ΔP inside sterile area.
• On-job training for specialists, technician supervisor & technicians about GMP regulations.
• Batch record review, revise logbooks and other documents related to sterile area.
• Represent production department in validation team.
• Represent production department in internal audit team.
• On job training for operators about GMP regulations during cleaning & operation of filling machines.
• Follow-up receiving of primary packaging materials for CAM & BOTTLE PACK filling machine.
• Follow up machine filling rates.
• Complete filling stage in batch record.
• Follow-up recording in logbooks.
• Receiving of raw materials from WH.
• Complete reconciliations of capping, over printing, check weigh, labeling & packaging stages in batch record.
• Follow up record in capping, over printing, check weigh, labeling & packaging logbooks.
• Recommends measures to improve production process.
• Periodic updates of production plan to manage the timelines for workloads.

Job Requirements

• Bachelor's degree in pharmaceutical science.
• At least 3 years experience in production in a pharmaceutical firm.
• A basic understanding of production processes and production equipment.
• Excellent English, verbal / written communication
• Ability to work well through others
• Excellent computer skills
• Has the skill of leadership.