Job Description:
1. Performance and management of calibration activities for all measuring instruments
- Maintenance of list of measuring instruments with status
- Maintenance the plan of calibration activities
- Maintenance the list of contracted/external calibration activities
- Manage all activities for camera systems
- Management of Calibration plan
- Performs on a regular basis the tasks that are necessary to ensure that the camera systems operate in a suitable condition (daily, weekly and monthly checks, maintenance) and supervision of it
- Responsible for transition processes the glassware area
- Inventory maintains a list of the camera systems under its jurisdiction
- Supervision of all results from checking the correctness of rejection mechanism of cameras on production equipment, measuring the ones
- Management of laboratory equipment calibration
- Conducts trainings for employees
- Consulting and help to the colleagues working with measurement devices
2. Performance and management of qualification activities
- Management of overall qualification activities at site with support of global and external contractors
- Maintenance of list of qualified instruments with status
- Maintenance the plan of qualification activities
- Maintenance the list of contracted/external qualification activities
- Manage all activities for requalification
- Management of Qualification plan
- Participation and support of qualification activities performed and lead by global team or external qualification contractors for facility, equipment (production and lab), clean rooms
3. Participation and management of environmental plan
- Preparation and follow-up of environmental monitoring plan
- Management of particle counts external or internal
- Preparation of environmental monitoring reports
- Actively participation in case of out os specification results
- Management of all calibration and qualification documentation
4. Other
- The employee is obliged to comply with the GMP, occupational safety, fire protection, environmental protection and EHS rules defined and taught by the organization, and to support work according to LEAN principles
- Appropriate use of personal protective equipment, following the dress code
- Management of up-to-date, maintenance and follow-up of measuring instrument records
- Management of documentation related to the listed activities, maintenance of office 5S, organization of documents
- Controls that measuring equipment is used correctly
- Consulting and help to the colleagues working with measurement devices
- Follows the requirements of work and operation instructions and company's procedures
- Conducts trainings for employees if there is a malfunction of equipment which endangers human being, environment or production.
Job requirements:
- Good command of English
- Project & Risk management, ISO sampling
- Decision making, ISO 15378,
- MS Office / M365 / cGMP / GDocP
- Advantage: GMP, German, SAP
- 3-5 years experience in manufacturing (GMP environment is an advantage)
SCHOT PHARMA D.O.O.
We design solutions grounded in science to ensure medicines are safe and easy to use for people around the world. A proud team of more than 4.700 people globally in 15 countries and 18 locations, serving 25.000 patients every minute on a global scale. We have partnered with most prominent pharmaceutical companies providing to them drug containment and drug delivery solutions and some of them will be our customers in the new, state of the art, facility in Jagodina.