Senior Officer

1 day ago

Dadra and Nagar Haveli, India SUN PHARMA Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Job Summary
The QC Analyst is responsible for performing analytical testing of raw materials, in-process samples, and finished pharmaceutical products to ensure compliance with USFDA regulations, cGMP standards, and internal specifications. This role is critical in maintaining product quality, safety, and efficacy.

Key Responsibilities

  • Analytical Testing:

  • Conduct chemical, physical, and microbiological tests using techniques such as HPLC, GC, UV-Vis, FTIR, titration, and dissolution.

  • Perform stability studies and method validation as per regulatory guidelines.

  • Documentation & Compliance:

  • Maintain accurate and complete records of all testing activities in compliance with GDP.

  • Document and investigate any Out-of-Specification (OOS) results.

  • Ensure adherence to cGMP, GLP, and USFDA regulations.

  • Equipment Handling:

  • Calibrate, maintain, and troubleshoot laboratory instruments.

  • Ensure proper usage and upkeep of analytical equipment.

  • Cross-Functional Collaboration:

  • Coordinate with Production, QA, and R&D teams to resolve quality issues.

  • Participate in internal and external audits.

  • Continuous Improvement:

  • Assist in developing and validating new analytical methods.

  • Recommend improvements to testing procedures and quality systems.

*Qualifications:*

  • Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or related field.
  • 2–5 years of experience in a pharmaceutical QC laboratory, preferably in a USFDA-approved facility.
  • Hands-on experience with analytical instruments and techniques.
  • Knowledge of regulatory guidelines (USFDA, ICH, WHO).
  • Strong attention to detail and analytical skills.

*Preferred Certifications:*

  • Certified Quality Analyst (CQA)
  • Training in cGMP, GLP, and data integrity

*Soft Skills:*

  • Excellent communication and documentation skills
  • Ability to work independently and in a team
  • Problem-solving and critical thinking abilities

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