Job Opening For Quality Control Department At Stallion Laboratories

Quality Control (QC) Department in the Pharmaceutical Industry

The Quality Control (QC) Department in the pharmaceutical industry plays a crucial role in ensuring that drugs and medical products meet regulatory standards, safety requirements, and efficacy parameters.

1. Objectives of the QC Department

• Ensure product quality by conducting analytical and microbiological testing.
• Verify compliance with Good Manufacturing Practices (GMP) and regulatory guidelines (e.g., FDA, EMA, WHO).
• Detect and prevent contamination, defects, or inconsistencies in raw materials, packaging materials, and finished products.
• Maintain data integrity and ensure all laboratory practices follow Good Laboratory Practices (GLP).

2. Key Responsibilities

A. Raw Material Testing

• Conduct tests on active pharmaceutical ingredients (APIs) and excipients.
• Verify identity, purity, and potency of raw materials before production.

B. In-Process Quality Control (IPQC)

• Monitor critical manufacturing steps, such as blending, granulation, compression, and coating.
• Ensure batch consistency and compliance with specifications.

C. Finished Product Testing

• Perform physical, chemical, and microbiological analysis of the final product.
• Verify dissolution, disintegration, assay, and stability studies.

D. Stability Testing

• Conduct long-term and accelerated stability studies to assess shelf-life.
• Ensure products retain quality throughout their expiration period.

E. Microbiological Testing

• Test for microbial contamination in raw materials, water, and finished products.
• Conduct sterility tests for injectables, ophthalmic solutions, and sterile products.

F. Environmental Monitoring

• Monitor air, water, and surfaces in cleanrooms and production areas.
• Ensure aseptic conditions for sterile manufacturing.

G. Documentation & Compliance

• Maintain detailed test reports, Certificates of Analysis (CoA), and batch records.
• Ensure regulatory compliance with GMP, GLP, and ISO standards.

3. Equipment Used in QC Laboratories

• Chromatography Techniques: HPLC, GC, TLC
• Spectroscopy: UV-Vis, FTIR, Atomic Absorption
• Microbiological Testing Tools: Petri plates, Bioburden analyzers
• Dissolution & Disintegration Testers
• Karl Fischer Titrator (for moisture content)

4. Regulatory Guidelines for QC

• US FDA: Good Manufacturing Practices (GMP) Regulations
• European Medicines Agency (EMA): EU GMP Guidelines
• World Health Organization (WHO): International Standards
• ICH Guidelines (Q1–Q9): Cover stability, validation, and analytical methods

5. Common Challenges in QC

• Data integrity issues and compliance risks
• Contamination risks and environmental control
• Ensuring analytical method validation and reproducibility
• Meeting strict regulatory expectations and frequent inspections

6. Importance of QC in Pharmaceuticals

• Protects patient safety by ensuring product quality
• Prevents costly recalls and regulatory actions
• Ensures brand reputation and trust in the pharmaceutical industry

Opening at Stallion Laboratories PVT LTD (a well known Formulation unit) for its manufacturing plants based at Bavla Ahmedabad as per below :

Department: QC (GLP,HPLC, LIMS, MICRO)

Designation: Officer/Sr.Officer

Education Qualification: B.Pharm/M.Sc.

Experience: 3 to 7 Years

Interested Candidates email their cv to Darshan.mistry@stallionlabs.com