Serves as the point of contact for the local Health Authority for PV related questions from the Health Authorities (when assigned).
Oversees all daily PV processes and activities within the countries covered by the country operation as required.
Establishes and coordinates reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations
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Ensure tests and other tasks assigned are performed in a timely manner in compliance to Standard Operating procedures, requirements specified in our company Quality and Safety Standards, regulatory dossiers and pharmacopoeia.
Manage and perform calibration, maintenance and qualification of laboratory equipment.
Participate in laboratory efficiency improvement tasks, analytical method transfer, development, validation and equipment qualifications activities.
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Plans, organizes, performs engineering and maintenance activities related to the installation, modifications, troubleshooting, repairs, calibrations and maintenance of equipment / system to ensure that they are safe, efficiently, reliable and meet GMP/ regulatory / production requirements.
Other engineering activities include maintaining spares and parts storage, operation of utilities supplies and up-keeping of facilities.
Assists team lead to complete work activities timely, efficiently and satisfactorily
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Plans, organizes, performs engineering and maintenance activities related to the installation, modifications, troubleshooting, repairs, calibrations and maintenance of equipment / system to ensure that they are safe, efficiently, reliable and meet GMP/ regulatory / production requirements.
Other engineering activities include maintaining spares and parts storage, operation of utilities supplies and up-keeping of facilities.
Assists team lead to complete work activities timely, efficiently and satisfactorily
...