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

• Apply advanced and mastered knowledge of concepts, methods, terminology, codes, quality standards and specialised job requirements
• Escalate out-of-policy 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