Job Description

6-9 yrs. of experience with practical experience in calibration of Analytical and process instruments/equipment

Knowledge of the following is required:

• Operation and calibration of various analytical equipments like HPLC, GC, UPLC, LCMS/MS, GCMS/MS, ICPMS, Balances, pH meters, KF etc.,
• Expertise in Empower3 application
• Calibration procedures, tools and processes
• Calibration database systems like Blue Mountain and EAMS will be an added advantage
• Experience in establishing SOP\xe2\x80\x99s
• Knowledge on metrological standards and investigations through Trackwise
• Operation and calibration of Standard instruments
• Regulatory Guidelines for GMP and documentation review skills
• Effective problem solving capabilities
• Excellent Interpersonal, written and communication skills
• Expertise in reviewing the chromatograms of HPLC,UPLC,GC &ICP-MS and calibration data.

Responsibilities

• To lead the team of 2-3 members for managing the calibration of various analytical equipments typically used in the Pharmaceutical industry as per the SOP.
• Plan and coordinate with the external vendors performing calibration and maintenance activities onsite/offsite.
• Review, Archive and maintain the calibration records.
• Investigate the out of tolerance results during the calibration through Trackwise.
• Order and maintain the standard solutions and standard instruments required for the calibration.
• Ensure inspection readiness in calibration across the laboratories Publish metrics reports on calibration, on-time performance and alert on open issues.
• Prepare and maintain the calibration and maintenance schedules for instruments and ensure the state of calibration is valid
• Develop, implement and maintain calibration procedures for new equipment and Provide the support for OQ/PQ during qualifications
• Provide support to the site in reviewing the potential product impact due to an out of tolerance conditions during calibration
• Provides expert support for troubleshooting during calibration and maintenance
• Provide technical guidance and support of new projects in specifying new instruments and calibration methods for new instruments
• As requested, present and support the calibration program during internal and external audits.
• Perform routine field inspections of calibration status labelling to ensure compliance

Qualifications:

B.Pharm/MPharm/MSC chemistry

BE (Electronics, instrumentaiton)
Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Engineering

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Pfizer