Currently working as Senior Production officer in
Incepta Pharmaceuticals Limited (UK MHRA certified organization, exporting
pharmaceutical products to 95 countries of the world) from 1 December 2019 to Present.
❖ Job Responsibilities:
• Have a working experience in solid & Liquid dosage form (Tablet, Capsule, Syrup &
Suspension) & sterile manufacturing (Insulin).
• Complete the production tasks assigned by the factory, timely develop production plans,
and complete production tasks on time with quality and quantity guaranteed.
• According to the requirements of GMP, compile production process regulations, standard
operating procedures, cleaning and hygiene systems, and other production management
systems, supervise and inspect the implementation of management systems.
• Timely handle abnormal problems in the production process. In case of major quality
accidents, safety accidents, etc., report to the supervisor of the factory leadership in a
timely manner and notify relevant departments.
• Check the work situation of process technicians and team leaders, as well as the quality of
process discipline, labor discipline, intermediate products, and finished products.
• Operate machinery to assist in the production process
• Review and approve batch production records, change control requests, validation
protocols, equipment maintenance & calibration schedules, product complaint
investigation, product specification documents.
• Assists in pilot scale trials of products under development.
• Participate internal and external audit.
• Prepare monthly production statistics, including output, consumption, yield (or finished
product rate), first-pass yield, and internal control compliance rate, report to the factory
leadership as well as quality management department.
• Maintain good workshop environmental hygiene, process hygiene, and supervise and
inspect personal hygiene to create a production environment that meets GMP
requirements.
• Assist the engineering department and quality management department in completing
process certification, equipment certification, clean room management, finished product
inspection, etc.
• Provide quality education and technical training to all employees in the workshop, including
legal education, labor discipline, safety education, hygiene education, GMP document
education, job skills training and assessment, etc.
• Organize safety inspections every week, fill out the “Safety Inspection Record”, record the
code, inspection date, serial number, the rectification situation of the previously discovered
problems, newly discovered safety problems, the department where the problems are
located, the department responsible for rectification, the completion date of rectification,
the recorder, and the production department leader.
• Strictly control the materials, equipment, facilities, and factory buildings used in the
production process to meet regulatory requirements. Strictly control the production process
to minimize potential hazards that may affect product quality.
• Accurately and timely submit relevant reports. Collect and organize batch production
records and submit them to the quality management department in a timely manner.
• Collect and organize consumption data of materials and consumables used in the
production process, and cooperate with the supply department, engineering department,
and finance department to determine various consumption indicators.
• Key achievements:
• Improved productivity by an average of 25% per year through Lean Manufacturing
Practice.
• Continuously aim to improve accuracy of master formulas through communication with
Quality Assurance department.
- Company industry:
- Pharmaceutical Manufacturing
Personal Website