Job Description

Job Summary

Competent and detail-oriented QC Analyst to support Quality Control activities for Oral Solid Dosage (OSD) formulations. The incumbent will be responsible for sampling, testing, and release of Raw Materials (RM) and Packing Materials (PM) and Finished Product (FP) in accordance with approved specifications, cGMP requirements, and internal quality standards. The role requires hands-on expertise in analytical instrumentation, laboratory documentation, data integrity practices, and adherence to regulatory requirements.

Key Responsibilities

Analytical Testing

• Perform sampling and analysis of Raw Materials and Packing Materials as per approved specifications, STPs, and pharmacopoeial requirements.
• Execute routine quality control testing and ensure timely reporting of results.
• Prepare and review analytical records, worksheets, and test reports.

Instrument Operation & Maintenance

• Operate, maintain, and troubleshoot analytical instruments, including:
• HPLC (High-Performance Liquid Chromatography)
• GC (Gas Chromatography)
• Auto Titrator
• Karl Fischer Titrator
• UV-Visible Spectrophotometer
• FTIR Spectrophotometer
• Ensure proper use, cleaning, and upkeep of laboratory equipment as per approved SOPs.
• Perform instrument calibration, verification, and routine maintenance activities as per schedule.

Documentation & Compliance

• Maintain accurate and complete analytical records in compliance with cGMP, GLP, and ALCOA+ data integrity principles.
• Ensure proper documentation, logbook entries, laboratory registers, and traceability of all activities.
• Maintain compliance with SOPs, STPs, specifications, and applicable regulatory requirements.
• Perform SAP transactions related to sample tracking, result entry, and documentation management.

Investigation & Quality Systems

• Support investigations related to OOS (Out of Specification), OOT (Out of Trend), deviations, and laboratory incidents.
• Report discrepancies, abnormal observations, and incidents promptly to the Group Leader.
• Participate in CAPA implementation and effectiveness monitoring.

Laboratory Operations

• Manage the handling and storage of chemicals, solvents, reference standards, and laboratory consumables.
• Prepare, standardize, and maintain volumetric solutions, reagents, and laboratory records.
• Prepare samples for external laboratory testing whenever required.
• Ensure timely destruction and disposal of retained samples as per approved procedures.
• Generate and print Certificates of Analysis (COA) as required.

Safety & Housekeeping

• Adhere to laboratory safety requirements, JSA (Job Safety Analysis), and EHS guidelines.
• Ensure proper usage of Personal Protective Equipment (PPE).
• Maintain laboratory cleanliness, safety standards, and good housekeeping practices at all times.
• Follow all safety precautions during sample handling and analysis.

Training & Continuous Improvement

• Complete assigned training programs within the stipulated timelines.
• Support audits, inspections, and compliance initiatives.
• Undertake any additional responsibilities assigned by the Group Leader or Department Head.

Educational Qualification

• M.Sc. in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or related discipline.

Experience

• 4–6 years of experience in Quality Control within the pharmaceutical industry, preferably in Oral Solid Dosage (OSD) manufacturing.
• Experience in handling analytical instruments and testing of Raw Materials and Packing Materials is essential.

Technical Skills

• Strong knowledge of analytical testing techniques for Raw Materials and Packing Materials.
• Hands-on experience with HPLC, GC, KF, UV-Visible Spectrophotometer, FTIR, and Auto Titrator.
• Knowledge of cGMP, GLP, data integrity and regulatory compliance requirements.
• Familiarity with SAP/LIMS and laboratory documentation systems.
• Experience in calibration, verification, and maintenance of laboratory instruments.
• Understanding of OOS, OOT, deviations, CAPA, and investigation processes.
• Proficiency in preparation and standardization of reagents and volumetric solutions.

Behavioural Competencies

• Strong attention to detail and accuracy in analysis and documentation.
• Effective communication and interpersonal skills.
• Good problem-solving and troubleshooting abilities.
• Ability to work collaboratively in a cross-functional environment.
• High level of integrity, accountability, and compliance orientation.
• Proactive approach toward laboratory operations, safety, and continuous improvement.

Preferred Industry: Pharmaceutical Manufacturing – Oral Solid Dosage (Tablets, Capsules, Granules)

Function: Quality Control (QC)

Additional Information

Not Applicable