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.
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
Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CVs online on or before the specified date. Preference will be given to applicants from designated groups, through a fair recruitment and selection process, in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate.
Only short-listed candidates will be contacted, thus if you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.
Internal Applicants must inform their direct line managers of their application. Applications must be completed using an Aspen email address.