Website Aspen Pharma
Aspen focuses on marketing and manufacturing a broad range of post-patent, branded medicines and domestic brands covering both hospital and consumer markets through our key business segments. Our key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands.
Description
Overview
- Perform microbiological tests on raw materials, water, cleaning and environmental samples, in-process and final products to ensure quality and compliance
- Review compliance of documentation according to pharmaceutical standards
Responsibilities
- Planning and Operational Support
- Optimise and facilitate implementation of current processes
- Identify gaps in current policies and procedures
- Propose changes or improvements to processes, tools and techniques
- Microbiological Testing
- Perform microbiological tests on raw materials, in-process and final products to ensure quality and compliance with GMP standards
- Test water according to SOPs and testing schedule
- Notify Production of source of any contamination timeously
- Develop and implement plans to control level and source of contamination
- Environmental Management
- Perform sampling and testing of external environment, according to SOPs and sampling plan/ schedule
- Quality Control
- Report OOS results and deviations immediately
- Manage frequency of testing and sampling to maintain a quality process
- Maintain good housekeeping
- Manage and coordinate the use, maintenance and calibration of testing equipment according to SOPs
- Ensure continuous compliance of laboratory with GMP standards
- 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
Requirements
Skills Required
Background/experience
- National Diploma in Microbiology
- Microbiological laboratory experience with 6+ years experience
Specific job skills
- Advanced knowledge of microbiological testing methods
- Understanding of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Interrogating Information
- Following Procedures
- Maintaining Accuracy
- Customer Awareness
