Sterile Semi Solid Pharmacist - Senior Specialist At Orchidia Pharmaceuticals
Prepare operational schedules and coordinate manufacturing activities.
Monitor the production processes and its conformance to regulations and identifies any deviation and trend.
Ensure that plant facilities, utilities, equipments are maintained well to meet production plan.
Maintain batch record and relevant documents to ensure that all production steps are performed correctly, signed by production staff and quality assurance members.
Prepare plan for process validation and cleaning validation and execute the validation plan in coordination with validation team.
Ensure that all rules and regulations regarding GMP are followed.
Monitor safety programs to eliminate industrial accidents.
Document procedures used to assemble; process and test company's products.
Monitor effectiveness of production process and determines any necessary changes to processes, equipment to support the production activity.
Supervise preparation, filtration and 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%, temperature, and differential pressure inside sterile area.
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.
Conduct on job training for operators about GMP regulations during cleaning and operation of filling machines.
Follow up receiving of primary packaging materials for CAM and BOTTLE PACK filling machine.
Follow up machine filling rates.
Complete filling stage in batch record.
Follow up recording in logbooks.
Receive raw materials from warehouse.
Complete reconciliations of capping, over printing, check weigh, labeling and packaging stages in batch record.
Follow up record in capping, over printing, check weigh, labeling and packaging logbooks.
Work through, follow and adhere to safety instructions and requirements in production areas.
Work according to GLP, GMP and GDP rules.
Shall be consulted and participated in the EHS management system and its improvement elements.
Areas of Responsibilities and Authorities
Follow up production schedule.
Monitoring the production processes and adjusting schedules.
Supervising and motivating a team of workers.
Ensuring adherence to safety regulations.
Production operations in compliance with quality system.
Education, Skills and Experience required
Bachelor’s degree in pharmaceutical sciences or science.
From 3 to 5 years of experience in production in pharmaceutical firm.
A basic understanding of production processes and production equipment.
Good track record on meeting/ exceeding customer expectation.
Good planning and management by objectives.
Excellent English, verbal/written communication.
Ability to work well through others
Excellent computer skills.