Quality Control Officer

Sterling Healthcare; Maharashtra; On-site; INR 450,000 - 650,000; Full time

Job summary

Sterling Healthcare is seeking a Quality Control Officer for its Formulation Oral Solid Dosage (OSD) Plant located in Talegaon, Pune. The role focuses on analytical testing of materials and products, ensuring compliance with GMP and data integrity standards.

The candidate will perform HPLC analyses, operate QC equipment, prepare solutions, and maintain thorough documentation throughout stability studies and release activities in a regulated setting.

Qualifications

• 2–4 years of relevant experience in Quality Control within a pharmaceutical formulation/OSD manufacturing plant.
• Hands-on experience in HPLC and finished-product/raw-material analysis.
• Strong documentation and data integrity practices.

Responsibilities

• Analyze raw materials, packing materials, semi-finished and finished products per SOPs and methods.
• Operate and maintain QC instruments (HPLC, KF, MPA, potentiometer).
• Prepare standard solutions and reagents per procedures.
• Review data, chromatograms and records for accuracy and completeness.
• Ensure GMP/GLP compliance and proper sample handling.

Skills

HPLC analysis

Volumetric prep

KF

Melting point

Pharmaceutical analysis

Data integrity

OOS/OOT

IP/BP/USP

Education

M.Sc. Chemistry

Tools

HPLC

Karl Fischer

Melting Point Apparatus

Potentiometer

Job description

Job Title - Quality Control Officer

Department: Quality Control
Industry: Sterling Healthcare
Location: Talegaon, Pune
Function: Quality Control Formulation (OSD Plant)
Experience: 24 Years
Qualification: M.Sc. Chemistry

Job Summary

We are looking for a skilled and detail-oriented Quality Control Officer for our Formulation Oral Solid Dosage (OSD) Plant. The candidate will be responsible for analytical testing of raw materials, in-process/semi-finished products, finished products, and stability samples in compliance with approved specifications, SOPs, GMP requirements, and data integrity practices.

Key Responsibilities

• Perform analysis of raw materials, packing materials, semi-finished products, finished products, and stability samples as per approved specifications and analytical methods.
• Perform analysis using HPLC and other laboratory instruments.
• Operate, calibrate, and maintain QC laboratory instruments such as HPLC, Karl Fischer (KF), Melting Point Apparatus, Potentiometer, and other analytical equipment.
• Prepare and standardize volumetric solutions, reagent solutions, and analytical solutions as per approved procedures.
• Handle and maintain primary standards, working standards, reference standards, and column standards as per SOPs and pharmacopeial requirements.
• Perform HPLC column handling, conditioning, maintenance, storage, and troubleshooting as applicable.
• Review analytical data, calculations, chromatograms, and laboratory records for accuracy and completeness.
• Prepare and maintain stability study documentation and analytical records.
• Ensure proper documentation of laboratory activities in accordance with GMP, GLP, SOPs, and data integrity requirements.
• Investigate analytical discrepancies, out-of-specification (OOS), out-of-trend (OOT), and atypical results in coordination with the QC team.
• Ensure proper handling, labeling, storage, and disposal of chemicals, reagents, standards, and samples.
• Participate in method verification/validation, instrument qualification, and other QC-related activities as required.
• Maintain laboratory housekeeping and ensure compliance with safety requirements.
• Coordinate with Production, QA, and other relevant departments for timely completion of testing and release activities.

Required Technical Skills

• Good hands-on experience in HPLC analysis and chromatographic data interpretation.
• Knowledge of volumetric solution preparation and standardization.
• Practical knowledge of KF, potentiometer, melting point apparatus, and other routine QC instruments.
• Knowledge of pharmaceutical analytical techniques and OSD formulation testing.
• Understanding of GMP, GLP, SOPs, OOS/OOT, stability studies, and data integrity.
• Ability to accurately document analytical results and maintain QC records.
• Good understanding of pharmacopoeial requirements such as IP/BP/USP, as applicable.

Candidate Profile

• Qualification: M.Sc. in Chemistry / Analytical Chemistry or equivalent.
• Experience:
• 2–4 years of relevant experience in Quality Control within a pharmaceutical formulation/OSD manufacturing plant.
• Candidates with hands-on experience in HPLC and finished-product/raw-material analysis will be preferred.
• Good analytical, documentation, communication, and problem-solving skills.
• Ability to work effectively in a regulated pharmaceutical manufacturing environment.