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Scientist III Verifications - Hyderabad @ United States

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 Scientist III Verifications - Hyderabad

Job 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.

  • Prepares and reviews SOPs.

  • 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.

Required Skills

  • 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, 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.

Required Experience

  • Master s degree in pharmacy or Analytical chemistry.

  • Minimum 5 to 7 years of relevant laboratory experience.

  • Prior experience in a high volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical testing laboratory.

Job Classification

Industry: Pharma, Biotech, Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: R&D
Role: R&D
Employement Type: Full time

Education

Under Graduation: Any Graduate in Any Specialization
Post Graduation: Any Postgraduate in Any Specialization
Doctorate: Doctorate Not Required, Any Doctorate in Any Specialization

Contact Details:

Company: United States
Location(s): Hyderabad

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Keyskills:   Housekeeping QA Analytical Pharmacy Pharma Instrumentation GLP ISO 17025 Technical support HPLC

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United States

United States Pharmacopeia-India (P) Limited