EW Analyst
HRSI
Published Date: • Jamshoro, Pakistan (On-Site)
Description
The EW Analyst at HRSI plays a crucial role in ensuring the quality and compliance of semi-finished and finished products through detailed laboratory analysis. This position involves timely testing and approval of NPI batches, process validation, and cleaning validation of pharmaceutical products. The analyst accurately receives laboratory samples, maintains meticulous records, and ensures all documentation adheres to data integrity principles, such as ALCOA plus. Maintaining an organized and compliant laboratory environment is vital, including 5S practices for lab glassware and proper handling of lab reagents. The role mandates strict adherence to Good Manufacturing Practices (GMP), environmental health and safety guidelines, and other corporate standards. The EW Analyst does not manage a team but collaborates closely with reporting managers to support audit preparations and promptly reports any out-of-trend (OOT), out-of-specification (OOS), atypical events, and deviations. Responsibilities further extend to proper disposal of waste and maintaining the cleanliness and readiness of laboratory tools and environments. The role demands a proactive approach to regulatory compliance to support the company’s commitment to quality and safety in pharmaceutical manufacturing processes.
Responsibilities
- Conduct analysis of semi-finished and finished products for timely approval, including NPI batches, process validation, and cleaning validation testing.
- Receive laboratory samples and maintain accurate and organized records of samples and test results.
- Complete and maintain all related documentation such as LIMS reports and logbooks following data integrity principles, especially ALCOA plus.
- Maintain 5S standards in the laboratory, focusing on the cleanliness and organization of lab glassware and equipment.
- Monitor and report any out-of-trend (OOT), out-of-specification (OOS), atypical events, and deviations promptly to the appropriate authorities.
- Ensure proper disposal of waste in compliance with safety and environmental guidelines.
- Inspect, clean, and maintain laboratory glassware to ensure readiness and prevent contamination.
- Manage laboratory reagents with attention to chemical compatibility and storage requirements.
- Support audit preparation activities in coordination with the reporting manager and assist in providing necessary documentation and information.
- Comply with and promote adherence to Good Manufacturing Practices (GMP), quality policies, and corporate guidelines.
- Ensure compliance with environment, health, and safety policies and relevant legal requirements.
- Perform additional duties as assigned to meet evolving business and compliance requirements.
Experience
Fresh
Apply By
Required Skills
- Laboratory Testing
- Data integrity (ALCOA plus)
- Process Validation
- Cleaning Validation
- Environmental Health and Safety Compliance
Nice to Have Skills
- NPI batches
- GMP
- 5S Methodology
- Audit Support
- Waste Disposal Management
- Laboratory reagent management