Senior QC- Formulation

20 hours ago

Hyderabad, Telangana, India SVK PHARMA PRIVATE LIMITED Full time ₹ 72,00,000 - ₹ 1,50,00,000 per year

Job Title: Senior QC Executive – Formulations

Department: Senior Quality Control (QC)

Location: Cherlapally

Experience: 4–8 years (in QC – Formulations)

Qualification: B.Pharm / M.Pharm / M.Sc (Analytical Chemistry preferred)

Industry: Pharmaceutical Formulations (Pellets)

Job Summary:

We are looking for a skilled and experienced Senior QC Executive – Formulations to manage analytical testing and validation activities in the Quality Control department. The candidate should have hands-on experience in HPLC, UV spectrophotometry, analytical method validation, and routine quality control testing for pharmaceutical formulations.

Key Responsibilities:1. Analytical Operations

  • Perform routine and stability analysis of finished products and raw materials using HPLC, UV, and other analytical instruments.
  • Handle HPLC instrument calibration, troubleshooting, and maintenance.
  • Prepare and review analytical test reports, chromatograms, and related documentation.
  • Conduct assay, dissolution, related substances, and content uniformity tests.

2. Method Development & Validation

  • Support analytical method development, transfer, and validation as per ICH guidelines.
  • Prepare and execute method validation protocols and reports.
  • Evaluate analytical data for accuracy, precision, and compliance with specifications.

3. Documentation & Compliance

  • Prepare and review SOPs, STPs, and specifications related to QC activities.
  • Ensure compliance with cGMP, GLP, and data integrity requirements.
  • Maintain proper laboratory documentation and instrument logbooks.
  • Participate in OOS/OOT investigations and implement CAPA where necessary.

4. Instrument Handling & Calibration

  • Operate and maintain analytical instruments like HPLC, UV, FTIR, pH meter, dissolution tester, balance, and KF titrator.
  • Ensure timely instrument qualification (IQ/OQ/PQ) and calibration activities.
  • Coordinate with service engineers for preventive maintenance and troubleshooting.

5. Quality System & Audits

  • Participate in internal and external audits (regulatory / customer).
  • Ensure adherence to laboratory safety and quality system requirements.
  • Train junior analysts on analytical techniques and documentation practices.

Required Skills & Competencies:

  • Hands-on experience in HPLC operation and method validation (Empower / Chromeleon preferred).
  • Strong understanding of pharmaceutical formulation analysis and regulatory guidelines (ICH, WHO, USFDA, MHRA).
  • Excellent knowledge of UV spectrophotometry and other QC instruments.
  • Good communication, analytical, and documentation skills.
  • Ability to work independently and manage multiple analytical tasks.

Job Type: Full-time

Pay: ₹20, ₹60,000.00 per month

Work Location: In person

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