Hiring For Quality Control Department At Alembic Pharmaceuticals

Opportunity at Alembic Pharmaceuticals

We at Alembic Pharmaceuticals Limited are looking for an Executive - Quality Assurance - (Validation) for our Indore site.

Position:

- Executive - QA

- Location: Indore

- Qualification: B. Pharma / M.Pharm

- Experience: 5-8 years

Must have Skills

Validation, Qualification and QMS

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Key Responsibilities of QC Department

1. Raw Material Testing

• Analyzing active pharmaceutical ingredients (APIs), excipients, and packaging materials.
• Ensuring compliance with pharmacopeial standards (e.g., USP, BP, EP).
• Conducting identity, purity, and potency tests.

2. In-Process Quality Control (IPQC)

• Monitoring production parameters at different stages.
• Conducting uniformity, weight variation, and hardness tests for tablets.
• Checking pH, viscosity, and other critical parameters.

3. Finished Product Testing

• Conducting assays for potency and purity.
• Dissolution and disintegration testing.
• Microbial testing for sterility and endotoxins (for sterile products).

4. Stability Studies

• Performing long-term, accelerated, and stress testing.
• Ensuring products meet shelf-life and storage conditions.

5. Microbiological Testing

• Sterility testing for injectables, ophthalmics, etc.
• Microbial limit testing for non-sterile products.
• Environmental monitoring in cleanrooms.

6. Documentation & Compliance

• Preparing Certificates of Analysis (CoA).
• Maintaining batch records, Standard Operating Procedures (SOPs), and test reports.
• Ensuring compliance with regulatory bodies like FDA, WHO, EMA, MHRA.

7. Calibration & Validation

• Validating analytical methods (HPLC, GC, UV, etc.).
• Calibration of instruments to ensure accuracy.

8. Handling of Non-Conformities & OOS Investigations

• Investigating Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
• Implementing corrective and preventive actions (CAPA).

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Common Instruments Used in QC

• HPLC (High-Performance Liquid Chromatography) – For drug content and impurity analysis.
• GC (Gas Chromatography) – For volatile compounds.
• UV-Vis Spectrophotometer – For absorbance-based testing.
• FTIR (Fourier Transform Infrared Spectroscopy) – For material identification.
• Dissolution Apparatus – For drug release studies.
• Karl Fischer Titrator – For moisture content analysis.

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Good to Have Skills

✔ Validation, PQ, OQ, IQ, Quality Management, CAPA, Change control, Qualifications, Water Validation, Equipment Qualification, Investigation, Qualification Protocols and Deviation.

Interested candidates are requested to share their profile along with current and expected CTC at Pratiksha.dubey@alembic.co.in