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 SOPs 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 a 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 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
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