- 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 "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.
- Environmental related to manufacturing/production/warehouse 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 ozone.
- While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear. The employee is frequently required to stand, walk, sit and stoop, kneel, crouch, crawl, push, and bend.
- Must be capable of bending and lifting, moving and/or carrying up to approximately pounds.
- Must be able to move pallets/equipment weighing about pounds using suitable moving equipment such as pallet jacks / Hi-Lo.
- Must have the ability to stand, ambulate and reach as required by job duties while navigating the office, lab, warehouse, and/or plant floor working environments.
- Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.
- 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).
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Metrologist I - New Brunswick, United States - Sun Pharmaceutical Industries
Description
Job Title:
Metrologist I
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.
Experience:
Minimum of two (2) years of Pharmaceutical Industry Laboratory experience
Duties and Responsibilities:
Work Conditions:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Qualifications/Education:
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).
EEO Notice:
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 Sun 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 referra
