Key duties and responsibilities
- General Responsibilities: To support needed resources on validations and re validations for equipment involved with different processes.
- To verify that equipment and process has been properly installed and validated before usage.
- Communicate if anomalies are detected on the test and measured equipment’s calibrated by QC, and if one is out of calibration.
- Process control specifications are followed, and it is properly recorded.
- Give support to maintenance supervisors by solving any problem with equipment, machinery and contact Denmark o suppliers if it is necessary.
- Excellent handling of inventory of spare parts to avoid jeopardize the production.
- To investigate and fix malfunctions of equipment's and systems with recurring problems
- To contribute our production schedules are completed with Quantity, Efficiency and on time.
- Meet with all those applicable requirements of the ISO 13485 & FDA, CGMP.
- Responsible to develop and sustain a training program for new personnel, make sure the follow up and record it.
- and keep updated all the team.
- Support to provide training in handling and safety for the equipment's for the production operators.
- To follow up of the general procedures, organizational plans, strategies and polices of ID Mexico.
- To hire, train, and keep the personnel in the department, following the policies established in the company.
- Plan and follow the requirements of the approved budget.
- Supervise and manage the daily activities within the members of the department.
- Review and approve with a functional approach all Quality system documents related to the department.
- Support on implementation of preventive and corrective actions as much to the quality system (processes and clean room) as like to the safety system previous to processes problems analysis done by those departments.
- To follow the safety rules of the company and the government.
- Fulfill with the quality objectives.
- Avoid stoppa