Job Description

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

Skills Required