4 days ago
Job title : LQR Analyst (Port Elizabeth)
Job Location : Eastern Cape, Port Elizabeth
Deadline : December 06, 2024
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Description
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 SOP’s an 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.
- Utilise technology as per qualification requirements.
Requirements
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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