Analyst Microbiological QC

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