Scope :
Supports the client in meeting excellent quality performance by executing various tests on materials or products in order to report on the results.
RESPONSIBILITIES Tests :
- Execute and evaluate microbiological tests (on raw materials/semi-finished products (bulk)/finished products and packaging materials) according to pharmacopoeia and internal procedures and standards.
Perform all tests based on testing monographs and in accordance with SOPs.
- Write the analysis reports.
- Enter the results of the test clearly, completely and correctly into the LIMS system.
- Initiate deviation reports, initiate « Out Of Trend » or « Out Of Spec » investigation as needed and report the findings.
- Review test results of other analysts
- Prepare media for execution of tests and control media by growth promotion tests.
- Identification of micro-organisms recovered from the tests.
Improvement :
- Propose new or adapted equipment and instruments for the laboratory.
- Propose and initiate changes in SOPs. Procedures :
- Perform all lab activities according to cGMP guidelines.
- Read and handle pharmacopoeia and standards if necessary.
- Perform calibrations of balances and glassware and other small instruments.
- Daily review of temperature and humidity registrations of equipment.
- Test and evaluate water controls of city-water, DI-water, WFI and clean steam.
Additional Tasks:
- Execute various tasks assigned by supervision (e.g. special request testing, stability testing, identification of finished products, water analysis, in-process testing, …).
- Responsible for peer-to-peer training.
- Responsible for the cleanliness in the lab according to the housekeeping program.
The tasks are mainly operational tasks following the precise guidelines: complete the tests within the required finishing-periods according to the priorities set by the Supervisor. The tasks to be performed have limited diversity: routine and experience are used to solve the majority of problems.
FUNCTION REQUIREMENTS
* Diploma: Bachelor degree in science and preferably experience of 2 years or more in a similar lab, or junior with (micro)biology background
* Technical skills : Knowledge of aseptic techniques.
* Active/good knowledge of Dutch and English, Passive knowledge/ notions of French
Personal skills :
* Being able to work independently
* Good communication skills
* Team spirit
* Sense of responsibility
* Problem solving skills
* Accuracy
* Planning of own work
Behavioral competencies:
* Action oriented
* Dealing with ambiguity
* Integrity and trust
* Perseverance
* Time management Composure : Advanced
* Decision Quality : Advanced
* Priority Setting : Advanced
Regime:
-shiftwork; day - early - late