- Experience Needed:
- More than 10 years
- Career Level:
- Job Type:
- Full Time
About the Job
- Ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.
- Approve the instructions relating to production operations and to ensure their strict implementation.
- Ensure that the production records are evaluated and signed by an authorized person before they are sent to the Quality Control Department.
- Check the maintenance of his department, premises, and equipment.
- Ensure that the appropriate validations are done.
- Ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
- Set production implementation plan and schedules.
- Observe workers/staff to ensure compliance with cGMP, GPS and set Standard Operating Procedures.
- Apply any changes in manufacturing / Packaging Procedures and coordinates with QC / QA for investigation and other actions to be taken.
- Review and control the batch production operation specifications and approve the master production insertions.
- Accurately assess the time and resources needed to accomplish a task and develop a realistic schedule.
- Approve purchasing of production requirements with pre-scheduled expenses in the budget.
- Inspects machine and equipment to ensure operational performance and optimum utilization.
- Implement manufacturing processes that foster high quality, cost efficiency, and compliance with all approved regulatory requirements.
- Follow up daily production output and drive for continuous improvement.
- Approve delivery of finished goods to a warehouse.
- Authorize destruction of all types of waste for production.
- Coordinate with Validation and Engineering to compose between available capacity and product volume achievement.
- Organize a complex task involving a mix of resources including people, data, material, machines, etc.
- Create and develop a high-performing team committed to the mission and will effectively lead the achievement of desired goals.
- Provide, supervise, document and evaluate on-the-job training activities for all staff.
- Help to promote team effectiveness by encouraging or facilitating the resolution of conflicts.
- Take critical decisions for rescheduling production to overcome any problem.
- Work closely with Engineering, QC, and QA to solve any problems related to productivity or product quality.
- Work with the Research & Development Manager to introduce new products on time and to continue to improve the performance of the manufacturing process.
- Revise monthly records of products (quality and quantity) and analyze variances against standard and monitors discrepancies.
- Approve production expenses (Overtime – Part-time wages - Transportation).
- Set departmental expenses and capital requirements for new machines and equipment.
- Set standard hours and yields for all products during the preparation of the annual budget.
- Set clear expectations and accountability.
- Set objectives and carry out performance evaluation for production pharmacists.
- Approve schedule for employees’ job function training.
- Revise records for employee's job function training.
- Plan manpower for Production staff during the year and coordinate with the HR Department to fill any vacancies that might occur during the year.
- Understand needs and considers external customers and/or internal clients in decisions and actions.
- Responsible for determination of hazards, risk factors, environmental aspects, and their evaluation.
- Responsible for compliance with legal and other requirements in his department.
- Commitment to emergency plan execution.
- Assessment of production feasibility for new introductions, either for in-house or outsourced production
- Harmonize toll manufacturing activities
More than 10 years
Not Specified at least