Job Details
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Job Description
Job Purpose:
- The main purpose of this job is to perform chemical analysis for validation samples for products according to the approved method of analysis, and prepare relevant documentation as required.
- Perform analytical method validation studies ,Protocols & final reports.
- Perform recovery studies & prepare cleaning validation & verification runs.
Responsibilities and Tasks:
- Performs all physicochemical testing of samples collected during the process validation and record the results in the validation report & Certificates of analysis required and ensures that all obtained results are within the specified approved limit, using valid method of analysis.
- Performs the analytical transfer analysis according to respective protocol.
- Immediate reporting of out of specification test results or batch deviation reports whenever needed to the AD lab head and the Q.C manager.
- Perform analytical full method validation studies ,Protocols & final reports.
- Updating of SOPs & control test methods and maintaining of relevant master files.
- Performs Standardization for Raw Materials
- Perform Stability testing & routine analysis tasks as assigned
- Perform recovery studies & prepare cleaning validation & verfirication runs.
- Responsible for HSE compliance in Q.C chemical labs as Q.C representative in HSE Excellence team
- Fulfill other task(s) as assigned
HSE & energy Contribution:
- Ensures HSE & energy approval on any SOP that requires certain HSE precautions.
- Ensures HSE & energy approval on any change.
- Following the laboratory safety procedures Commitment to the appropriate PPE use.
- Following the approved HSE & energy policy and requirements.
- Following the statutory legislation concerning Health, Safety, environmental & energy law. Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.
- Implementing good calibration program for all instruments.
- Ensures that risk assessment to any new transferred product is adequately covered.
- Ensures the availability of MSDS for any raw, auxiliary materials or chemicals used in labs.
Job Requirements
- Education: Bachelor Degree in Pharmacy
- Related Experience: 3 -5 years experience in similar positions
- Command of English Language
- Good command of MS Word, Excel & Power Point.
- Familiar with new instrumental analysis techniques
Desirable” / compromise experience
TQM Diploma
