Job Description

Description Roles and Responsibilities:

• 
  Executes the Verification projects by performing individual analytical tests allotted by the Group Leader.
• 
  Completes the projects as per the project timelines and priorities.
• 
  Demonstrates solid scientific approach to analysis in the laboratory.
• 
  Routinely applies personal experience, academic training, and technical insights – including emerging sciences – to solve complex technical problems within the laboratory;
• 
  Compiles project reports and responds QA observations.
• 
  Executes all testing and analysis of data with excellence and essentially no errors;
• 
  Demonstrates a strong desire to continue learning and grow personal capability;
• 
  Pursues, recommends, and implements new approaches or processes to improve laboratory operations;
• 
  Positively influences project direction by ensuring own work is congruent with overall direction of laboratory projects;
• 
  Assists with other testing programs and housekeeping duties in the laboratory as needed.
• 
  Ensures the implementation of GLP, safety systems in labs.
• 
  Ensures the calibration of the equipment as per the schedule.
• 
  Indents chemicals, columns, Glassware, etc. and procures them by coordinating with lab operations and purchase department in advance keeping in mind the project deadlines.
• 
  Ensures and follows USP mission, policies and procedures.
• 
  Maintains good relationship with QA, HR, Purchase, accounting, IT and other dept.
• 
  Preparation and planning for ISO-9001 & ISO- 17025 certification/recertification by participating actively and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.
• 
  Supports collaborative testing, GPH, RSL and other departmental teams in terms of project testing, review, execution and approval whenever needed.

Basic Qualifications: Education:

• Master’s degree in pharmacy or Analytical chemistry.

Experience :

• Minimum 5 to 7 years of relevant analytical laboratory experience. (API and formulations)

Preferred Qualifications: Ability to lead projects to completion with a high degree of scientific expertise. Proficient with pharmaceutical testing requirements and test protocols involving compendial methods (USP, BP, EP, etc.). Expert in ICP-OES, HPLC, GC,ICP-MS,LC-MS, Dissolution analysis and troubleshooting, proficient in other related analytical instrumentation (IR, KF,DT, UV, etc), strong communication and presentation skills, both verbal and written, experience working in the pharmaceutical industry strongly preferred. Knowledge of DEA, ICH guidelines and FDA regulations, and experience with compendial procedures and compliance strongly preferred. Proficiency with electronic documentation systems strongly preferred. Takes personal responsibility to ensure work is delivered on time and is the highest possible quality. Skills to anticipate, troubleshoot, and solve technical problems. Supervisory Responsibilities: No Job Category Chemistry & Scientific Standards Job Type Full-Time