LQR Analyst at Aspen Pharma Group

Job purpose

• 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.
• 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.
• Utilize 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