Metrologist I

4 weeks ago


Fredericton, New Brunswick, Canada SUN PHARMA Full time

Job Summary

Sun Pharma is seeking a skilled Metrologist I to join our team in the laboratory. As a Metrologist I, you will be responsible for performing and assisting with all essential tasks related to the calibration and qualification of laboratory instruments. This includes preventative maintenance, calibration, and qualification of laboratory instruments in accordance with all applicable SOPs to ensure adherence to cGMP in support of the laboratory operation.

Key Responsibilities

  • Preparation of master Preventive Maintenance/Calibration schedule.
  • Planning, execution, and review of instrument calibration/qualification related activities as per the calibration master plan.
  • Draft and review of instrument operation, maintenance, and calibration procedures.
  • Initiate change controls for new and existing instruments and its procedures.
  • Concurrent documentation of all raw data, observations in the notebook or applicable documents.
  • Notify to the supervisor any anomalous or OOC results. Notify the management for any observations or deviations.
  • Adhere to cGMP and safety procedures.
  • Review and report any applicable calibration/qualification documents.
  • Logging and attending instrument repair requests.
  • Scheduling visit for outside contractors for preventive maintenance or repair.
  • Placing "out of service tag" on instrument due for calibration, instrument requiring a repair or on a new instrument.
  • Opening the investigations and conduct primary investigation under direct guidance from management.
  • Ensure adequate labeling of all instruments and ensure instrument calibration status.
  • Order and maintain spare parts for major instrument to ensure continuous support of the analysis.
  • Verify the expiry date of chemicals, reagents, primary calibrators prior to use.

Work Conditions:

This role is based in a manufacturing/production/laboratory environment. The employee will be exposed to various environmental conditions, including noise, fumes, odors, gases, dust, and hazards.

Physical Requirements:

  • Able to lift and carry up to 50 lbs.
  • While performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle objects, or feel objects, tools, or controls; and reach with hands and arms.
  • The employee is occasionally required to stand, stoop, kneel, and crouch.
  • Specific vision abilities required of this job include close vision, distance vision, color vision, and the ability to adjust focus.

Travel Estimate

Up to 5%

Education and Job Qualification

  • Minimum BS or equivalent degree in Chemistry or related discipline.
  • In-depth knowledge of analytical instrumentation such as HPLC, GC, FTIR, UV, and practice.
  • Practical problem-solving skills for instrumentation troubleshooting.
  • Knowledge of ICH and FDA regulatory guidance.
  • Must be familiar with cGMP/GLP practices for analytical laboratories and EHS/OSHA safety regulations.
  • Excellent written and verbal communication skills and working knowledge of Microsoft Office Applications.
  • A self-starter with a hands-on approach and a can-do attitude.
  • The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Experience:

  • Minimum of two years of Pharmaceutical Industry Laboratory experience

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