Executive, Analytical R & D-ARPL-NOS AR

Apotex Pharmachem India Pvt Ltd. is bulk drug Pharmaceutical Company situated in the Bommasandra Industrial Area in Bangalore. It is mainly into R & D activities of APIs or Active Pharmaceutical Ingredients along with support activities like Quality Assurance, Quality Control and Analytical Services. Its parent company is situated in Canada. It is certified as Great Place to Work for the year 2017-18 from an Institute of Grate Place to work

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.
  

Apotex Pharmachem India Pvt Ltd. is bulk drug Pharmaceutical Company situated in the Bommasandra Industrial Area in Bangalore. It is mainly into R & D activities of APIs or Active Pharmaceutical Ingredients along with support activities like Quality Assurance, Quality Control and Analytical Services. Its parent company is situated in Canada. It is certified as Great Place to Work for the year 2017-18 from an Institute of Grate Place to work