LQR Analyst (Port Elizabeth) needed at Aspen Pharma Group

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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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