- 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.
- 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.
- 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 SOPs and documentation.
- Ensure adherence by Analyst/ Tester before release.
- 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
- National Diploma in Analytical Chemistry with 6+ years experience
- Laboratory experience
- 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.
- Interrogating Information
- Following Procedures
- Maintaining Accuracy
- Customer Awareness
