Role & Responsibilities:

- Perform Analytical Method Validation (AMV) activities, including designing validation protocols, executing validation studies, and documenting results for analytical methods used in raw materials, in-process, and finished product testing.
- Participate in method transfer activities from R&D; to QC and from QC to production, ensuring completion of all validation steps in line with GMP and regulatory guidelines.
- Conduct data analysis and interpretation from validation and verification studies to confirm analytical method accuracy, precision, specificity, and robustness.
- Ensure all compliance and documentation meet GMP, GLP, and regulatory standards; maintain accurate records of validation protocols, reports, and outcomes.
- Investigate and troubleshoot analytical method or equipment issues encountered during validation or routine analysis.
- Maintain regulatory compliance with current FDA, EMA, ICH, and other applicable guidelines related to analytical method validation.
- Provide training to QC staff on analytical methods, validation processes, and relevant regulatory requirements.




- Participate in instrument qualification and calibration for analytical instruments such as HPLC, GC, UV-VIS, and FTIR.
- Support continuous improvement initiatives to enhance method performance, data accuracy, and compliance efficiency.

Preferred Candidate Profile:

- Education: Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field.
- Experience: Minimum 5 to 7 years of experience in analytical method validation, method development, or analytical testing within the pharmaceutical industry.
- Skills:
- Proficiency in analytical techniques such as HPLC, GC, UV-VIS, and FTIR.
- In-depth knowledge of analytical method validation per ICH Q2(R1) and related regulatory guidelines.
- Solid statistical analysis and data interpretation abilities.
- Thorough understanding of GMP, GLP, and FDA/EMA regulatory requirements.
- Excellent documentation, problem-solving, and communication skills.
- Ability to manage multiple validation projects and work effectively under pressure.
- Certifications: Certification in Analytical Chemistry or related areas will be an added advantage.

📌 Sr. Executive For QC (Una)
🏢 Stanford Laboratories
📍 Una