In the context of a laboratory to provide services for the Pharmaceutical Industry, we are looking for a Microbiologist with expertise in working in Quality Control Laboratory (GMP regulated).
QPLAB is a GMP certified laboratory with end-to-end services for the Pharmaceutical industry to approve and release medicinal products in the EU: Analytical services and EU Batch certification.
Responsibilities
- Perform microbiological testing of pharmaceutical products including identification of microorganisms, evaluation of results and elaboration of appropriate documentation.
- Perform growth promotion tests and approve all lab media.
- Support the Validation activities of microbiological analysis, including the execution of tests, evaluation of results, elaboration of protocols and reports.
- Participate in investigations associated with out of specification or out of trend product testing results.
- Participate in laboratory management including managing laboratory stock and replenish inventories.
- Support GMP inspection readiness in the laboratory. Improve lab quality systems; develop content, create and review SOPs and training as necessary.
- Communicate (verbally and in writing) proactively, be a team player and be a valuable contribution in order to provide the best service possible to each customer.
Skills
- University or Technical degree in Microbiology, Biochemistry, pharmaceutical sciences or similar
- Experience in the Pharmaceutical Industry area (minimum 1 year).
- Proven experience in a GMP regulated Pharmaceutical Industry QC laboratory environment (mandatory)
- Proven experience in a GMP Microbiology/Environmental Monitoring Laboratory, associated with product testing.
- Demonstrated proficiency in microbiological laboratory techniques including, but not limited to Bioburden testing, specific microorganism detection and water analysis.
- Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
- Deep understanding of compliance requirements and regulatory expectations.
- Additional preferences include experience in other microbiological tests such as preservative effectiveness test or rapid microbiological test methods.
- It is considered a plus the knowledge of method validation according to ICH guidelines.
- Knowledge of basic office tools.
- Good knowledge of English (written and spoken).