QC Analytical Method Validation

6 days ago


Indianapolis, United States Gandiva Insights LLC Full time

Role: QC Analytical Method Validation

Location: Indianapolis, IN

Duration: 6+months Contract


Job Description:

We are seeking a skilled and motivated Technical Writing Consultant with expertise in chemistry and analytical method validation to support our pharmaceutical operations. The ideal candidate will possess extensive hands-on experience with laboratory instruments such as HPLCs and other analytical tools, combined with strong technical writing skills to document and communicate validation processes effectively.


Key Responsibilities:

Prepare comprehensive, clear, and concise documentation, including validation reports, protocols, and SOPs, ensuring compliance with regulatory standards.

Execute and optimize analytical method validation studies for techniques such as HPLC, UPLC, and GC, ensuring accuracy and reproducibility.

Design and review validation protocols, defining method parameters, acceptance criteria, and testing conditions.

Interpret experimental data and compile regulatory-compliant validation reports (aligned with ICH, FDA, and EMA guidelines).

Ensure adherence to GMP, GLP, and regulatory requirements in all validation activities.

Provide technical expertise in resolving analytical challenges, instrument calibration issues, and method performance.

Work cross-functionally with R&D, QC, and Regulatory Affairs teams to meet project timelines and regulatory needs.

Mentor junior staff and conduct knowledge transfer on method validation best practices and instrumentation.


Qualifications:

Education: Bachelor's or higher degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or related fields.

Experience:

Minimum 6+ years in analytical method validation in the pharmaceutical/biotech industry.

Proficient in laboratory techniques using HPLC, UPLC, and GC equipment.

Strong background in technical writing for reports, protocols, and SOPs.

Skills:

In-depth knowledge of analytical validation principles and regulatory guidelines (e.g., ICH, USP, FDA).

Excellent analytical, problem-solving, and communication skills.

Proficiency in presenting complex technical data clearly to diverse audiences.



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