1. Documentation:
Record testing results on analytical batch record correctly and ensure that no errors have occurred or, if errors have occurred, ensure that they have been fully recorded to be investigated.
Retain records in accordance with approved procedures, GMP, ISO 9001:2015, ISO 13485:2016 and ISO 15378:2017 and regulatory requirements.
Record any activity performed on the related document. (Ex: equipment logbooks, reagents logbooks, calibration/verification sheet...)
Report any out of specification/out of trend deviation, change control, non-conforming products and investigations.
Perform the investigation related to an out of specification/out of trend deviation for the laboratory errors, under the supervision of the senior and supervisor.
Write needed documents related to QC activities.
Implement the instructions related to QC operations.
2.Quality Control activities:
Implement all operations in accordance with written procedures and all testing operations according to the approved methods.
Follow and apply plant hygiene procedures in a very strict way.
Perform quality control physicochemical testing and analysis for finished products.
Prepare all needed reagents for the respective tests.
Execute environmental monitoring sampling and testing of classified areas according to the requirements.
Perform Physico-chemical water sampling and testing for the whole system from wells to WFI Point of use.
Perform required Physico-chemical in-process sampling and testing.
Perform required equipment verifications in production department.
Perform required raw materials and packaging materials sampling and testing.
Prepare test reports & recording of raw materials, packaging materials, bulk products, and finished products.
Perform stability testing of the products and report the results to the QC manager.
Provide support in the validation of the quality control methods when applicable.
Others:
Accept and work any task related to quality control activity required by Quality Control Manager(Pharmacist in Charge and Research).
Qualifications:
Education: Bachelor's degree in Biochemistry or Chemistry
Experience: 0-1 year
Skills:
Excellent verbal and written communication skills
Quality focus
Problem solving
Attention to details