Senior Officer - Quality Control

Job Summary

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