Senior LQR Analyst at Aspen Pharma Group

Job description

Laboratory Quality Review (LQR):

• Maintains/ drive adherence to data integrity
• Perform quality review of analytical data according to schedule
• Ensure that all queries are actioned by relevant laboratory personnel
• Ensure that all OOS / analytical incidents are well investigated , documented and escalated to the relevant line management
• Ensure that all OOS investigations are executed and completed as required (including calibration and maintenance) and on time
• Report all OOS’s to relevant Line Management
• Assist in OOS data trends
• Ensure that records are evaluated and corrected before they are sent to the Quality Department.
• Investigate and initiate corrective actions for all quality deficiencies.
• Verify the validity of COA, calibration certificates,
• Ensure that audit trails for instruments are reviewed and approved
• Reviews and approves results on QMS II

Perform Analysis

• Evaluate analytical methods for new specification/products
• Request changes to MOA’s
• Initiate requests for reagents and standards
• Check the availability of all consumables before analysis
• Prepare and perform QC assessment of reagents
• Check expiry date at time of use
• Perform analysis using appropriate equipment and related techniques according to schedule
• Analyse non-routine/special request investigations according to target date
• Ensure that all system suitability requirements are met
• Enter and control data according to GMP/GLP
• Maintain standard forms, analyst notebooks logbooks and electronic laboratory records
• Provide detail observations from the analysis of data and interpretation of results
• Communicate deviations
• Perform quality control review of data
• Compare results to specifications
• Perform analytical investigations according to SOP, on out of specification (OOS) results
• Verify the validity of an out of spec result
• Compile analytical/technical reports

Requirements

• Matric
• National Diploma in Analytical Chemistry/ BSc Chemistry or equivalent
• 3-5 years laboratory experience
• Experience with Quality Management Systems.
• Experience with requirements of GLP/GMP