Production Section Head At Orchidia Pharmaceutical Industries
Job Description
Lead to get things done through production team members, make decisions, allocate resources and direct the activities of others to attain goals, do their work in an organization lead the department to achieve high production plan, GMP and safety delivery of the needed pack in the right time with the right quality with the least cost per pack.
Essential Tasks:
Supervise production pharmacist, senior pharmacist, chemist and supervisors.
Prepare operational schedules and coordinates manufacturing activities.
Monitor 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.
Review batch record and relevant documents to ensure that all production steps are performed correctly, signed by production staff and quality assurance members.
Review plan for process validation and cleaning validation and execute the validation plan in coordination with validation team.
Review documents procedures used to assemble; process and test company’s products.
Review and monitor effectiveness of production process and determines any necessary changes to processes, equipment to support the production activity.
Review preparation, filtration and autoclaving processes.
Review integrity testing for used filters according to authorized SOP.
Review availability of all materials and availability for all production machines.
Insure cleaning and fumigation of sterile area on routinely basis.
Review BMS monitoring of RH%, temperature, and differential pressure inside sterile area.
Batch record review, revise logbooks and other documents related to sterile area.
Represent production departmental risk assessment.
Follow up KPI’s analysis and gap analysis.
Follow up all machine filling actual out-puts.
Review recording in logbooks.
Responsible for departmental CAPA closure.
Responsible for on job training for specialist, senior specialist, supervisor and technicians about GMP regulations.
Monitor safety programs to eliminate industrial accidents and follow up, maintain and ensure implementation of safety instructions and requirements in production areas.
Formulate and recommend technical training programs based on knowledge of identified training needs, company production processes or changes in products, procedures or services.
Follow up, maintain and ensure implementation of GLP, GMP and GDP rules.
Enforce subordinates’ participation and implementation of the EHS management system.
Skills
Bachelor’s degree in Pharmaceutical Sciences.
From 8 to 10 years of experience in production in pharmaceutical firm.
At least 4 years of experience in sterile area.
A basic understanding of production processes and production equipment.
Excellent leadership skills.
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.
Education
Pharmaceutical Science