Laboratory Quality Reviewer
Aspen Pharma Group
2022/01/18   Port Elizabeth

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Job Ref #: AP-3358
Industry: Pharmaceutical And Medical/Healthcare
Job Type: Permanent
Positions Available: 1

Applications are invited for the above indicated vacancy that exists in the OSD QC LAB. The successful incumbent will report to the Production Team Leader. All applications to be received on or before 25 Jan 2022. Preference will be given to Employment Equity candidates in line with Aspen’s Transformation Agenda.

Job 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 and 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

Record all OOS investigations and conclusions, and report to management

Provide advise 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 standardised reports and consolidated documents

Initiate deviations once picked up during reviewing.

 

Job Requirements

Skills Required

 

Background/experience

   

National Diploma in Analytical Chemistry

6 years 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