Job Description

Job Summary:




Team Leader Production - the role holder is responsible to adhere with cGMP principles and encourage compliance with Julphar policies and procedures, to maintain them in an effective manner as well as control overall production activities.



The role holder is responsible to operate the production equipment & monitor the production process as SOP & BMR, ensure the high level of productivity and promote achievement of daily & monthly production plan as scheduled. Assist with day to day managerial responsibilities, overseeing staff, must coordinate with all other departments for efficient running of production department, implement and check compliance of SOPs.


Key Responsibilities & Key Result Area




• Checking Dispensing of raw materials, Material preparation, Filtration, Filling, Inspection and Labelling in accordance with GMP Principle.
• Checking and review Machine Parts Assembling in the filling line and operations during the media fill and batch production process in the class - B Area.
• Preparation, review, and approvals of process-related documents like BMR, SOP, and Formats logbooks.
• Review of processed BMR's before releasing the product.
• Assist in Process Validation, Process optimization, Scale Up.
• Arranging the area cleaning Schedules and providing the proper disinfectants for area cleaning.
• Maintaining the state of clean-rooms Class-A & Class-B areas.
• Proper training for the aseptic operator for personnel behaviour in clean rooms.
• Investigates and troubleshoots problems that occur and determines solutions or recommendations for changes and/or improvements.
• Handling of EDMS and QMS tools like Change Control, Deviations, Exception, CAPA, etc.
• Writing, reviewing, and proposing new and updated SOPs and processes to improve the QMS and related systems.
• Implement production standards and adherence to cGMP principles & secure the safety and security of the process.
• Responsible for supervising and approving all production activities that take place in department.
• Control productivity level, produce accurate, high quality work in a time-sensitive fast paced environment to achieve monthly target within timeline, manage and distribute personnel duties to fulfill the plan.
• Responsible to secure that all production operations (BMRs, SOPs, and Logbooks) are carried out according to cGMP.
• Monitor the production process, ensure that Batch Manufacturing Records (BMR) is carried out and report to production manager in case of any deviation.
• Responsible to use SAP to approve process orders, set work priorities, set schedules, manages equipment and drive maintenance work practices.
• Set efficient and effective operation plans & goals, to be up-to-date to follow the market trend to develop Julphar's production operation process and responsible to implement these plans.
• Encourage the resources utilization, ensure that all production operations are cost effective through minimizing the waste (scrap) and rework, maximum capacity utilization with high yields.
• Ensure that production lines are checked in accordance with line clearance instructions before starting up a new production operation.
• Generate SAP notification for calibration due or maintenance.
• Coordinate with all support departments within and outside Julphar production to facilitate the required support to production process, review technical information for different manufacturing unit operations.



People Interface & Support




• Arrange work and prepare duty shift.
• Responsible for daily administrative procedures, overseeing staff, guide support, motivate employees to perform well.
• Monitor staff performance and function KPIs to ensure the organization objectives in the areas of cost, efficiency, and compliance are met.
• Responsible to train new staffs for the concerned area and processes involved.
• Participate in evaluation meetings, review performance appraisal reports, evaluate work performance.
• Maintain and promote a teamwork environment with effective and clear communication amongst co-workers
• Identifying training needs of subordinates and evaluating the training outcomes in coordination with the concerned employees in the HR and Admin Department
• Following-up employee affairs including vacations, leaves ...etc. in coordination with HR and Admin Department.


Core Competency


• In terms of Competency you are highly result oriented, dedicated with strong sense of accountability & ownership.
• You are a team player with a proactive approach.
• Good communication, interpersonal, and teamwork collaboration skills.
• Must be able to multitask, task prioritize without guidance and easily adopt to changing situations.
• Strong Manpower handling skills and motivational skills.
• Problem solving and high agility on taking right decisions.
• Ability to work effectively under pressure and meet established deadlines.
• Customer-oriented approach with strong aptitude.






Qualifications / Key Experiences/Functional Knowledge Requirement




• 4 years Bachelor's degree in Science/ Pharmacy or any equivalent field.
• At least 6-8 years' experience in similar organization in pharma / Health care / Medical Industry.
• Fluent in English (communicating, writing and speaking).
• Experience in office management software like MS Office (MS Excel and MS Word, etc.).
• Proven experience with Pharma Manufacturing operations, product process, and production.
• Pervious Knowledge with BMR and GMP compliance.
• Advance Knowledge with creating production plans and organizing production schedules.