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.
- Valuable 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.

Interested candidate Send Your Resume [email protected] [email protected]

📌 Quality Control Officer (Pune)
🏢 Sterling Healthcare
📍 Pune