Lab Quality Reviewer (Port Elizabeth) needed at Aspen Pharma Group

Job Expired
Save 1 month ago

Job title : Lab Quality Reviewer (Port Elizabeth)

Job Location : Eastern Cape, Port Elizabeth

Deadline : November 04, 2024

Quick Recommended Links

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

  • Science  jobs
  • This job has expired!

Share this job