1 month ago
Job title : Lab Quality Reviewer (Port Elizabeth)
Job Location : Eastern Cape, Port Elizabeth
Deadline : November 04, 2024
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Description
- 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
Requirements
- 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
How to Apply for this Offer
Interested and Qualified candidates should Click here to Apply Now
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