Overview
Lab Quality Reviewer Analyst Jobs in Port Elizabeth, Eastern Cape, South Africa at Aspen Pharma Group
Title: Lab Quality Reviewer Analyst
Company: Aspen Pharma Group
Location: Port Elizabeth, Eastern Cape, South Africa
Job Overview
Review and approve batch documentation in line with SOP and quality standards
Perform lab quality review in line with SOP
Provide services according to Production plan
Related administrative tasks
Responsibilities
Planning and Operational Support
Oversees work and/ or serve as a lead technical expert
Optimise and facilitate implementation of current processes
Identify gaps in current policies and procedures
Propose changes or improvements to processes, tools and techniques
Provide information for reports, as required by superior
Provide analytical support in the absence of the TL
Provide support during regulatory audits.
Lab Quality Review
Perform LQRs according to Production plan
Review and approve lab records to ensure pharmaceutical analysis has been carried out as per MOA; direct queries to laboratory
Electronic approval of analytical results on relevant software. e.g. Empower
Evaluate and interpret chromatography data to ensure accuracy of results.
Review and approve batch documentation compliance with SOPs and quality standards
Correct errors in batch documentation, in line with GMP standards, SOPs, and product specifications
Record all OOS investigations and conclusions, and report to management
Provide advise to analysts during laboratory investigations.
Provide input into SOPs
Ensure that products are produced, tested and stored according to the required SOP’s and documentation
Ensure adherence by Analyst/ Tester before release
Reporting and Record-Keeping
Document and store data according to SOPs and regulation
Consolidate information for reports on weekly/ monthly basis
Analyse consolidated data and provide recommendations
Compile detailed and standardised reports and consolidated documents
Initiate deviations once picked up during reviewing.
Background/experience
Skills Required
National Diploma in Analytical Chemistry with 6+ years’ experience
Laboratory experience
Specific Job Skills
Understanding of pharmaceutical manufacturing and corrective action programs
Pharmaceutical standards and compliance requirements
Ability to interpret and implement policies, processes and objectives
Strong technical knowledge and be competent in the use of all laboratory equipment, software and techniques.
Competencies
Interrogating Information
Following Procedures
Maintaining Accuracy
Customer Awareness
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