Executive, Analytical R & D-ARPL-NOS AR

Job Summary

Execution of analytical method optimization /development, validation/ verification of analytical test 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 updations.Preparation of method validation/verification protocols and reports.

Job Responsibilities

• Execution of Method optimization / development studies. Method validation/ verification of In-house methods, Compendia, SDC, MLCM and Cleaning Analytical methods by adhering to the regulatory procedures.
• Preparation of Method verification/ Method transfer Protocols and reports.
• Execution of Method transfer analysis and reporting.
• Execution of analytical studies related to Regulatory queries/submisiion requirement.
• Perform all work in accordance with all established regulatory compliance and safety requirements.
• Responsible for the activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality system.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. 
• All other relevant duties as assigned.

Job Requirements

Education

• MinimumMSc/BPharm or any equivalent degree.

Knowledge, Skills and Abilities

• Command on Microsoft-Office (Word, Excel).
• Knowledge in Method optimization/development activities.
• Best in effective completion of work activities to meet the time lines.
• Able to perform multi parameter analysis on HPLC instrument.

Experience:

• Minimum 3 to 6 years of experience in GMP regulated Pharmaceutical Industry.