SUMMARY:
a Big Giant within the Pharmaceutical Industry is looking to employ a skillful LQR Analyst to join their dynamic team of experts urgently!!!!
POSITION INFO:
Overview
Position: Pharmaceutical LQR Analyst
Salary: Market Related
Location: Port Elizabeth
- Send detailed CV in Word Document, certified copy of Id, head and shoulders photo of yourself, pay slip, plus certified Qualifications. this is to speed up your application and to get the correct documentation to the Employer!!!!!!
Applicants are invited to apply for this excellent opportunity that exists for the above mentioned position. The successful incumbent will report to the QC Team Leader.
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
- 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 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.
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
NB! This job is now closed. You can apply for other jobs by uploading your CV.
