Lqr Analyst: Microbiology
2 weeks ago
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.
Skills required
Background/experience
- National Diploma (Analytical Chemistry, Biotechnology, Microbiology)
- 6+ years 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
Accountability & Decision Rights
- Escalate outofpolicy matters
Independent Decisions relating to:
- Correct and/ or contain errors of significant impact (financial loss, customer business, materials and/ or equipment downtime)
- Prioritise tasks and responsibilities within overall direction and clearly defined parameters/ schedules and established policies, practices, guidelines, and quality and safety checks
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