Quality Control-Chemists

Key Responsibilities

A. Analytical Testing & Laboratory Operations

- Perform routine and non-routine analysis of raw materials, intermediates, in-process samples, and finished products.
- Operate analytical instruments such as HPLC, GC, UV, IR, KF, and other laboratory equipment.
- Perform wet chemical analysis, titrations, loss on drying, pH, and other applicable tests.
- Ensure accurate testing, timely completion of analysis, and reporting of results.

B. Quality Systems & Compliance (QMS)

- Follow approved SOPs, STPs, specifications, and applicable GMP requirements.
- Identify and report Out of Specification (OOS), Out of Trend (OOT), deviations, and laboratory incidents.
- Participate in investigations and support the implementation of corrective and preventive actions (CAPA).
- Ensure compliance with data integrity principles (ALCOA+) during laboratory activities.

C. Documentation & Data Integrity

- Prepare and maintain analytical worksheets, laboratory records, logbooks, and instrument usage records.
- Ensure accurate and contemporaneous recording of analytical observations and results.
- Review analytical calculations and maintain proper documentation as per established procedures.
- Maintain proper documentation of laboratory activities in compliance with regulatory requirements.

D. Instrument Handling & Maintenance

- Ensure proper operation, cleaning, and maintenance of laboratory instruments.
- Perform instrument calibration checks and routine performance verification as per approved procedures.
- Report instrument breakdowns, abnormalities, and malfunctions to the concerned personnel.
- Maintain instrument logbooks and ensure equipment is in calibrated and qualified status before use.

E. Investigation & Quality Improvement

- Assist in OOS, OOT, deviation, and laboratory incident investigations.




- Identify potential causes of analytical failures and support root cause analysis.
- Implement assigned CAPA and ensure compliance with corrective actions.
- Identify opportunities to improve laboratory efficiency and analytical practices.

F. Audit & Regulatory Compliance

- Maintain laboratory readiness for internal, customer, and regulatory audits.
- Provide analytical records and supporting documents during audits.
- Support the closure of audit observations related to QC laboratory activities.
- Follow applicable GMP, GLP, and regulatory requirements.

G. Cross-Functional Coordination

- Coordinate with Production and QA departments for sample collection, analysis, and timely reporting of results.
- Ensure timely completion of testing to support production, batch release, and dispatch requirements.
- Communicate analytical discrepancies and quality-related issues to the reporting manager.

H. Training & Team Coordination

- Participate in technical and GMP-related training programs.
- Support the training and guidance of junior chemists and trainees.
- Maintain qualification and training records for assigned analytical activities.
- Ensure adherence to laboratory safety, housekeeping, and valuable laboratory practices.

Technical Skills & Competencies

- Practical experience in analytical testing of pharmaceutical APIs / bulk drugs.
- Hands-on experience with HPLC, GC, UV, IR, and KF instruments.
- Knowledge of wet chemical analysis and analytical calculations.
- Understanding of OOS, OOT, deviations, CAPA, and change control.
- Knowledge of GMP, GLP, SOPs, STPs, and data integrity (ALCOA+).
- Ability to interpret analytical results and identify discrepancies.
- Good documentation, communication, and coordination skills.

QUALIFICATION AND EXPERIENCE

- Education: M.Sc. in Chemistry (Organic/Analytical preferred)
- Experience: 3 to 6 years in Quality Control (Pharma/API industry)

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📌 Walk-in || UNIT-C, HYD, Quality Control-Chemist (Hyderabad)
🏢 Metrochem
📍 Hyderabad