Job Description

Perform or assist with all essential tasks including preventative maintenance, calibration, and qualification of laboratory instruments in accordance to all applicable SOP to ensure adherence to cGMP in support of the laboratory operation. Assist with instrument maintenance and schedule outside contractor where necessary.

Area Of Responsibility

• 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 instrument and its procedures.
• Concurrent documentation of all the 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 \xe2\x80\x9cout of service tag\xe2\x80\x9d 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:

Manufacturing/Production/Laboratory environment

Environmental related to manufacturing/production/laboratory environments:

• Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
• Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
• Odors: Unpleasant smells.
• Gases: Examples include carbon monoxide and helium.
• Dust: Airborne particles of any kind, such as textile dust, wood, and silica.
• Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock.

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

Experience:

• Minimum of two (2) years of Pharmaceutical Industry Laboratory experience

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Sun Pharmaceutical Industries