Quality Control Associate

Concept Medical; Surat; On-site; INR 3,00,000 - 6,00,000; Full time

Job summary

A leading medical technology firm in Surat is looking for a Quality Control Analyst to perform analyses on raw materials and finished products, ensuring compliance with GMP/GLP guidelines. You will operate and maintain analytical instruments such as HPLC, FTIR, and GC, while ensuring documentation accuracy and data integrity. Candidates should possess a B.Sc or M.Sc in Chemistry or related fields with 1-4 years of experience in a relevant QC laboratory environment. This role will significantly contribute to maintaining the quality standards essential for product safety and efficacy.

Qualifications

• Strong operating knowledge of HPLC, FTIR, and GC instruments.
• Hands-on experience in calibration, operation, and troubleshooting of HPLC systems.
• Understanding of GMP, GLP, GDP, and regulatory compliance requirements.

Responsibilities

• Perform analysis of raw materials, in-process samples, and finished products.
• Operate, calibrate, and maintain analytical instruments.
• Ensure proper documentation and data integrity in compliance with GMP and GLP guidelines.
• Coordinate with QA for out-of-specification investigations.

Skills

HPLC operation

FTIR operation

GC operation

Calibration of analytical instruments

GMP knowledge

GLP knowledge

Education

B.Sc / M.Sc in Chemistry / Analytical Chemistry / Pharmaceutical Sciences

Tools

HPLC

FTIR

GC

SAP

MS Office

Job description

Job Purpose:

To perform raw material, in-process, and finished product analysis using validated analytical techniques, ensuring compliance with GMP/GLP guidelines and regulatory requirements.

Key Responsibilities:

• Perform analysis of raw materials, in-process samples, and finished products as per approved specifications, test methods, and protocols.
• Operate, calibrate, and maintain analytical instruments including HPLC, FTIR, and GC.
• Troubleshoot analytical instruments, particularly HPLC systems, and ensure uninterrupted laboratory operations.
• Ensure proper documentation and data integrity in compliance with GMP and GLP guidelines.
• Maintain and update laboratory records, test reports, calibration records, logbooks, and analytical worksheets.
• Utilize server‑based chromatography software for data acquisition, processing, and reporting for HPLC and GC systems.
• Ensure compliance with Good Documentation Practices (GDP) at all times.
• Coordinate with QA for out‑of‑specification (OOS) investigations, deviations, and corrective actions when required.
• Ensure proper handling, labeling, storage, and disposal of samples and chemicals.
• Support internal and external audits by providing required documentation and technical explanations.

Technical Skills & Knowledge:

• Strong operating knowledge of HPLC, FTIR, and GC instruments.
• Hands‑on experience in calibration, operation, and troubleshooting of HPLC systems.
• Knowledge of SAP for material management, data entry, or quality‑related transactions.
• Proficiency in MS Office applications (Word, Excel, PowerPoint).
• Experience working with server‑based chromatography software for HPLC and GC.
• Understanding of GMP, GLP, GDP, and regulatory compliance requirements.

Educational Qualification:

• B.Sc / M.Sc in Chemistry / Analytical Chemistry / Pharmaceutical Sciences or equivalent.

Experience:

• 1–4 years of relevant experience in a QC laboratory within pharmaceutical / medical device / chemical manufacturing industries.