
Method Optimization Analyst
2 weeks ago
The Job Summary entails the execution of analytical method development, validation, and verification activities. This includes optimization and transfer methods related to Compendia, In-house developed methods, Site transfer methods, Regulatory queries, Method Life Cycle Management (MLCM) studies, Supplier Driven Changes (SDC), and other procedural updates.
Key Responsibilities:- Develop and optimize analytical methods in compliance with regulatory procedures.
- Validate and verify In-house methods, Compendia, SDC, MLCM, and Cleaning Analytical methods according to regulatory guidelines.
- Prepare protocols and reports for method verification and method transfer activities.
- Execute method transfer analysis and reporting tasks.
- Maintain regulatory compliance and safety requirements within the Quality Control Laboratory environment.
- Collaborate as a team member to achieve all outcomes in a safe and efficient manner.
This position requires a strong understanding of analytical methods, regulatory procedures, and laboratory operations. The ideal candidate will possess excellent communication and problem-solving skills, as well as the ability to work effectively in a team environment.
Required Skills and Qualifications:- Educational Background: Minimum Master's degree or equivalent qualification.
- Knowledge, Skills, and Abilities:
- Proficiency in Microsoft Office applications.
- Knowledge in analytical method development and optimization activities.
- Ability to perform multi-parameter analysis on HPLC instruments.
- Experience:
- Minimum 3-6 years of experience in GMP regulated Pharmaceutical Industry environments.
A dynamic work environment with opportunities for professional growth and development is offered by this company.
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