Laboratory Quality Reviewer (Port Elizabeth) needed at Aspen Pharma Group

Description
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 advice to analysts during laboratory investigations.
• Provide input into SOPs.
• Ensure that products are produced, tested and stored according to the required SOP’s an 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.
• Utilise technology as per qualification requirements.

Requirements
Skills Required Background/experience

• National Diploma in Analytical Chemistry with 6+ years’ experience
• Laboratory experienceSpecific 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