Quality Control Officer

Kopran Limited; Khopoli; Vor Ort; INR 600.000 - 900.000; Vollzeit

Zusammenfassung

Kopran Limited is seeking a QC Officer to lead quality control testing of raw materials, in-process samples, and finished products at our Savroli facility. You will operate instruments like HPLC, GC, UV-Vis, FTIR, and dissolution systems, ensuring compliance with SOPs and GMP standards.

The role requires a B.Sc./M.Sc. in Chemistry or Analytical Chemistry, with experience in pharmaceutical QC or willingness to consider freshers based on fit. Shift-based work may be required.

Qualifikationen

• Bachelors or Masters in chemistry or analytical chemistry or a relevant discipline.
• Experience in pharmaceutical QC preferred; freshers may be considered based on requirements.
• Knowledge of IP/BP/USP/EP pharmacopoeial standards and GDP.

Aufgaben

• Perform analysis of raw materials, packing materials, in-process samples, finished products, and stability samples as per specifications.
• Operate and maintain analytical instruments (HPLC, GC, UV/Vis, FTIR, dissolution apparatus, pH meter).
• Prepare and standardize volumetric solutions, reagents, and standards.
• Calibrate, verify, and maintain instruments as per procedures.
• Maintain laboratory records, worksheets, logbooks per GDP.
• Follow GMP/GLP/SOPs and data integrity requirements.
• Report OOS/OOT and any abnormal observations to the manager.
• Ensure proper handling, labeling, storage, and disposal of samples and chemicals.
• Support method validation/verification/transfer and stability studies.
• Assist in investigations, deviations, CAPA, and audits.

Kenntnisse

Quality control

Analytical techniques

GMP/GLP/GDP

Documentation

Problem solving

Shift work

Ausbildung

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

Relevant discipline

Tools

HPLC

GC

UV-Vis spectrophotometer

FTIR

Dissolution apparatus

pH meter

Jobbeschreibung

Department: Quality Control (QC)
Designation: QC Officer
Industry: Pharmaceutical Manufacturing
Qualification: B.Sc. / M.Sc. in Chemistry, Analytical Chemistry, or a relevant discipline
Experience: 23 years in a pharmaceutical industry (freshers may be considered, depending on requirements)
Location: Savroli, Khalapur, Raigad, Maharashtra
Reporting To: QC Executive / QC Manager

1. Job Purpose

To perform quality control testing of raw materials, packing materials, in-process samples, finished products, and stability samples in accordance with approved specifications, Standard Operating Procedures (SOPs), GMP requirements, and applicable regulatory guidelines.

2. Key Responsibilities

• Perform analysis of raw materials, packing materials, in-process samples, finished products, and stability samples as per approved specifications and test methods.
• Operate and maintain analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, dissolution apparatus, and pH meter, as applicable.
• Prepare and standardize volumetric solutions, reagents, and analytical standards.
• Perform instrument calibration, verification, and routine maintenance as per approved procedures.
• Maintain accurate laboratory records, analytical worksheets, logbooks, and other quality control documents in compliance with Good Documentation Practices (GDP).
• Follow current SOPs, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and data integrity requirements.
• Report Out-of-Specification (OOS), Out-of-Trend (OOT), and any abnormal analytical observations to the reporting manager.
• Ensure proper handling, labeling, storage, and disposal of laboratory samples, reagents, and chemicals.
• Support method validation, method verification, method transfer, and stability studies, as assigned.
• Assist in laboratory investigations, deviation handling, CAPA implementation, and audit-related activities.
• Ensure cleanliness, safety, and housekeeping of the QC laboratory.
• Coordinate with QA, Production, Warehouse, and other relevant departments for sample testing and timely reporting of results.

3. Required Skills

• Knowledge of pharmaceutical quality control testing and analytical techniques.
• Practical exposure to HPLC, GC, UV, FTIR, and other laboratory instruments, as applicable.
• Understanding of pharmacopoeial standards such as IP, BP, USP, and EP.
• Knowledge of GMP, GLP, GDP, SOPs, and data integrity principles.
• Good analytical, documentation, communication, and problem-solving skills.
• Ability to work in shifts, if required.

4. Key Performance Indicators (KPIs)

• Timely completion of sample analysis and reporting.
• Accuracy and reliability of analytical results.
• Compliance with SOPs, GMP, GLP, and data integrity requirements.
• Proper maintenance of laboratory records and instrument logbooks.
• Timely reporting and investigation support for OOS/OOT results.
• Laboratory safety, housekeeping, and audit compliance