Job Summary

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 and maintenance of master Preventive Maintenance/Calibration schedule.
• Planning, execution of instrument calibration/qualification related activities as per the calibration master plan.
• Preparation of instrument operation, maintenance and calibration procedures.
• Obtained a quote for instrument service and repairs.
• Prepare IQ/OP/PQ protocols for new instrument.
• 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 “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:

 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.

Travel Estimate

Up to  5%

Education and Job Qualification

      Education 

• Minimum BS or equivalent degree in Chemistry or related discipline.

      Requirements and Qualifications:

• 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 four (4) years of Pharmaceutical Industry Laboratory experience

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees 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 the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Taro employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.