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Lab Quality Reviewer

2 weeks ago

Port Elizabeth, South Africa Aspen Pharma Group Full time

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

**Planning and Operational Support**
- Oversees work and/ or serve as a lead technical expert
- Optimize 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 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 standardized reports and consolidated documents
- Initiate deviations once picked up during reviewing.

**Skills Required**:
**Background/experience**
- 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