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’s
- 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.
- 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
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.