QC Analyst At Hikma Pharmaceuticals
Job Summary:
Performing analysis and reporting of samples and may be assigned to any section such as raw material, finished product, validation, or stability, performs equipment calibration, documentation review, and confirmatory analysis within investigations, and participates in internal quality systems including training. This must be achieved through efficiency both in time and material resources, while ensuring compliance with GLP, company procedures, EH & S regulations as well as Pharmacopoeia standards.
Job description:
Performs a variety of routine and basic tests in support of routine testing for stability batches, production of intermediate samples, finished products, Raw Materials, and process/cleaning validation samples to ensure that materials comply with the standards as per the approved Hikma Testing Method.
Assists in reviewing technical documents to ensure the documents are up to standards and comply with regulations.
Implements procedures and systems to develop an appropriate level of expertise in order to ensure the successful execution of project work within the current pharmaceutical industry technical standards in addition to maintaining compliance with cGMP.
Assists in troubleshooting basic technical issues to support in efficiently solving these problems.
Assists in standardizing processes throughout the laboratory to ensure compliance with cGMP’s and current SOP’s.
Internal calibration of instruments according to work instructions.
Responsible for the proper implementation of 5S in the lab.
Properly disposing of all contaminants and different hazardous and bio-hazardous materials.
Preparation of chemical reagents and other required volumetric solutions.
Reporting and documenting any incidents, out of specifications and out of trend results according to the predetermined procedures.
Possess good awareness of basic GMP & GDP requirements.
Receiving of all batches (Pilot _ re-registration _ ongoing _ first three production batches) and putting them in the suitable chamber (Accelerated _Long-term _Intermediate).
Review routine bench work, analysts, and instruments logbooks.
Do all Physical and Chemical Analysis for All dosage units.
Ensures that all obtained results are within the specified approved limit, using a valid method of analysis.
Immediate reporting of out of specification test results and preparing deviation reports.
Perform Verification for method validation and performing samples for specific analysis in a specific matrix and making validation for test method.
Preparation registration files products and NODCAR files.
Writing and preparing Validation and Stability protocols for products.
Qualification:
BSC of Pharmacy or Science
Minimum years of experience 1:3 years
Prefer having experience in Stability.