Calibration lead -India – Chennai
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.
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.
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