SLTL Group - Medical Division
Website:
sltlmedical.com
Job details:
Job Summary
SLTL Medical Division is seeking a detail-oriented and experienced QC Executive to perform analytical testing and quality control activities using HPLC and other laboratory instruments. The candidate will be responsible for ensuring that raw materials, in-process samples, and finished products meet established quality standards and regulatory requirements.
Key Responsibilities
Analytical Testing
- Perform routine and non-routine analysis using HPLC.
- Conduct testing of raw materials, intermediates, finished products, and stability samples.
- Prepare mobile phases, reagents, standard solutions, and test samples.
- Ensure timely completion of sample analysis and reporting.
Instrument Operation & Maintenance
- Operate, calibrate, and maintain HPLC systems and other analytical instruments.
- Troubleshoot basic instrument issues and coordinate with service engineers when required.
- Maintain instrument logbooks and calibration records.
Documentation & Compliance
- Prepare and review analytical reports, worksheets, and test records.
- Ensure compliance with GMP, GLP, ISO 13485, and company quality standards.
- Maintain laboratory documentation as per regulatory requirements.
- Participate in internal and external audits.
Method Validation & Verification
- Assist in analytical method development, validation, verification, and transfer activities.
- Support investigations related to OOS (Out of Specification), OOT (Out of Trend), and deviations.
Quality Systems
- Follow SOPs and quality procedures.
- Participate in CAPA implementation and continuous improvement initiatives.
- Ensure laboratory cleanliness and adherence to safety guidelines.
Required Qualifications
Education
B.Sc./M.Sc. in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, Biotechnology, Life Sciences, or related field.
Experience
- 1 to 5 years of experience in Quality Control laboratory operations.
- Hands-on experience with HPLC analysis is mandatory.
- Experience in Medical Device, Pharmaceutical, Diagnostics, Healthcare, or related regulated industry preferred.
Technical Skills
- Strong knowledge of HPLC operation and troubleshooting.
- Understanding of analytical techniques and laboratory practices.
- Knowledge of GMP, GLP, ISO 13485, and regulatory requirements.
- Proficiency in MS Office and laboratory documentation.
Desired Competencies
- Strong analytical and problem-solving skills.
- Good communication and reporting abilities.
- Team player with a quality-focused mindset.
- Ability to work under deadlines and maintain accuracy.
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