Quality Control Executive

SLTL Group - Medical Division; Gandhinagar; On-site; INR 350,000 - 520,000; Full time

Job summary

SLTL Medical Division is seeking a detail-oriented QC Executive to perform analytical testing and quality control using HPLC and other lab instruments. You will ensure materials, in-process samples, and finished products meet quality standards and regulatory requirements.

The role involves instrument maintenance, documentation, and supporting GMP/GLP/ISO 13485 compliance, as well as participating in internal and external audits and continuous improvement initiatives.

Qualifications

• 1–5 years of experience in Quality Control laboratory operations.
• Hands-on experience with HPLC analysis is mandatory.
• Experience in medical devices, pharmaceuticals, diagnostics or regulated industries preferred.

Responsibilities

• Perform routine and non-routine analytical testing using HPLC.
• Operate, calibrate, and maintain HPLC systems and related instruments.
• Prepare mobile phases, reagents, standards, and test samples.
• Prepare analytical reports and ensure compliance with GMP/GLP/ISO 13485.
• Assist in audits and quality system improvements.

Skills

Analytical mindset

Attention to detail

Team collaboration

Problem-solving

Education

B.Sc./M.Sc. in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, Biotechnology, Life Sciences, or related field

Tools

HPLC

MS Office

Job description

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.