Job Purpose:

• To review analytical data for the disposition of batches with attention to data integrity

Key Job Outputs:

• Reviewing of data documented by laboratory personnel within laboratory notebooks, worksheets and instrument logbooks.
• Reviewing of documentation related to in-process, finished product, raw materials and stability testing in the laboratory
• Reviewing of audit trail to ensure that the electronic data generated is according to the applicable procedures.
• Performs review of analytical data and calculations associated with material testing, and analytical methods
• To priorities reviewing of analytical data to strict timescales and as per the emergency of release.
• Performs evaluation of Out of Specification with the laboratory analyst.
• Informs manager or designate of any critical data integrity or issue of irregularity.
• Review reagents, standards and standardized Solution in the “P” Book.
• Review the working and reference working Standards and verify that the correct grade and Potency has been used.
• Reviews that the Samples were taken from the correct sampling points and that testing was performed testing as per 03-15-23-004.
• Ensuring the Lab equipment in handled with care and non-abuse.
• Switching off the equipment when not in use.
• Ensuring cleanliness of the laboratory
• Follow Safety and GMP requirements as instructed
• Complying with Standard Operating Procedures (SOP’s)

Job Requirements
Required Learning: 

• BSc Degree or National Diploma in Chemistry
• 2 – 3 years Lab experience in Pharmaceutical Industry
• Knowledge of laboratory SOP’s
• Knowledge of pharmaceutical GMP
• Knowledge of using analytical instrumentation and data review
• Strong analytical and problem solving

Core Competencies:

• Judgement and Decision Making
• Verbal and written communication skills
• Customer Service Orientation
• Quality Orientation
• Assertiveness
• Rule orientation
• Flexibility
• Attention to detail
• Stress Handling