Quality control

Aurore Life Sciences Pvt Ltd; Hyderabad; On-site; INR 350,000 - 600,000; Full time

Job summary

Aurore Life Sciences Pvt Ltd in Hyderabad is seeking a Quality Control (QC) Analyst/Officer for API manufacturing. The role covers chemical, instrumental, and physical testing of raw materials, intermediates, in-process samples, and finished APIs to ensure compliance with approved specifications and GMP guidelines.

You will operate analytical instruments such as HPLC, GC, UV-Vis, FTIR, and Karl Fischer, prepare CoA and documentation, and participate in internal and regulatory audits while

Qualifications

• B.Sc. or M.Sc. in Chemistry or Analytical Chemistry required.
• Fresher to 5 years' experience in QC analysis in pharmaceutical manufacturing.
• Hands-on experience with HPLC, GC, and wet chemistry methods.
• Familiarity with GDP/ALCOA+ data integrity and regulatory guidelines.

Responsibilities

• Perform chemical, instrumental, and physical testing of inputs and finished APIs.
• Operate HPLC, GC, UV, FTIR, and other instruments per SOPs.
• Prepare CoA, worksheets, and ensure data integrity per ALCOA+.
• Support OOS/OOT investigations and CAPA activities.
• Maintain calibration and maintenance of analytical instruments.
• Ensure compliance with cGMP, ICH, IP, USP, EP requirements.

Skills

HPLC

GC

Wet chemistry

Documentation

ALCOA+ data integrity

cGMP/GLP/GDP

OOS/OOT investigations

CAPA implementation

Education

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

B.Pharm/M.Pharm (optional)

Tools

HPLC systems

GC instruments

pH meter

FTIR analyzer

Karl Fischer titration

Job description

Job Description: Quality Control (QC) API Pharmaceutical Industry

Job Title: Quality Control (QC) Analyst / Officer Active Pharmaceutical Ingredients (API)

Department: Quality Control / Quality Assurance

Industry: Pharmaceutical API Manufacturing

Reports To: QC Manager / Quality Control Head

1. Job Purpose

To perform chemical, instrumental, and physical testing of raw materials, intermediates, in-process samples, finished APIs, and stability samples to ensure compliance with approved specifications, pharmacopoeial requirements, GMP guidelines, and regulatory standards.

2. Key Responsibilities and Duties

A. Analytical Testing

• Perform analysis of raw materials, intermediates, in-process samples, and finished APIs.
• Operate analytical instruments such as HPLC, GC, UV-Visible spectrophotometer, FTIR, Karl Fischer, pH meter, and analytical balances.
• Perform tests such as assay, related substances, residual solvents, water content, loss on drying, identification, and impurity profiling.
• Conduct wet chemistry tests, including titration, limit tests, and volumetric analysis.
• Perform cleaning verification and validation sample analysis, as applicable.
• Analyze stability samples according to approved stability protocols.

B. Documentation and Data Integrity

• Prepare and maintain analytical worksheets, laboratory notebooks, and raw data.
• Review and maintain laboratory records, chromatograms, calculations, and instrument logs.
• Follow Good Documentation Practices (GDP) and ALCOA+ data integrity principles.
• Ensure accurate recording, traceability, and timely reporting of analytical results.
• Prepare and review Certificates of Analysis (CoA), where authorized.

C. GMP and Regulatory Compliance

• Follow current Good Manufacturing Practices (cGMP) and applicable SOPs.
• Ensure compliance with applicable ICH guidelines, pharmacopoeial standards (IP, USP, EP), and regulatory requirements.
• Participate in internal audits, customer audits, and regulatory inspections.
• Follow laboratory safety procedures and proper handling of chemicals, reagents, and reference standards.

D. OOS, OOT, and Laboratory Investigations

• Identify and report Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
• Participate in laboratory investigations and root cause analysis.
• Support CAPA implementation and effectiveness checks.
• Report deviations, atypical results, and instrument malfunctions to the supervisor.
• Follow approved investigation procedures without unauthorized retesting or resampling.

E. Instrument Calibration and Maintenance

• Perform routine instrument checks, calibration, and preventive maintenance as per SOPs.
• Maintain instrument usage logs and calibration records.
• Ensure instruments are qualified and suitable for intended use.
• Troubleshoot basic analytical instrument issues and coordinate with service engineers when required.

F. Laboratory Management

• Prepare and standardize volumetric solutions, reagents, and mobile phases.
• Maintain reference standards, working standards, and reagent inventory.
• Ensure proper sample labeling, storage, and disposal.
• Maintain laboratory cleanliness, housekeeping, and chemical safety practices.

3. Educational Qualifications

• B.Sc. / M.Sc. in Chemistry, Analytical Chemistry, or a related discipline.
• B.Pharm / M.Pharm may be acceptable, depending on the company's requirements.

4. Experience Requirements

• Fresher: Basic analytical chemistry knowledge and willingness to learn GMP laboratory practices.
• Experienced: Typically 1–5 years of experience in QC analysis in API or pharmaceutical manufacturing, depending on the position.
• Hands-on experience with HPLC, GC, wet chemistry, and analytical documentation is preferred.

5. Required Skills

• Knowledge of API manufacturing processes and analytical testing.
• Practical experience with HPLC and GC.
• Understanding of cGMP, GLP, GDP, and ALCOA+ principles.
• Knowledge of OOS/OOT investigations, deviations, and CAPA.
• Good analytical, troubleshooting, and documentation skills.
• Ability to follow SOPs and meet testing timelines.
• Strong attention to detail and commitment to data integrity.