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Manager Instrumentation


Austin, TX 78728
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Job Details

To manage the team responsible for new equipment qualification, calibration, Preventive maintenance and instrument breakdown related activities in a GMP environment with due consideration to Compliance, Quality and Organizational Goals.

+ Manage the instrumentation (/metrology) team effectively such that the availability of major chromatographic (HPLC / UPLC / GC / IC) and essential equipment's (Balances, pH meters, KF, UV, FTIR and Polarimeter) for the labs are in the range of 80-90% at all time.

+ Manage the Installation & Qualification activities for all lab instruments / equipment's.

+ Manage troubleshooting, maintenance & calibration of all lab equipment's (both process development and analytical).

+ Managing scheduled PMPs for all lab instruments / equipment's.

+ Managing audit trails, user types, groups and privileges in EMPOWER software through IT support.

+ Manage investigations, CCF, CAPA and events.

+ Managing Empower data server with IT support and audit trial / data back-up for all equipment's.

+ Managing vendor maintenance program, spare parts storage for all lrequired equipment's.

+ Manage effectively with engineering team, User Department, Quality, and Validation team to ensure completion of instrumentation related activities.

+ Managing harmonization of SOPs, Creation/Amendment of SOPs for new and existing equipment's to be in-line with the regulatory requirements.

+ To ensure adequate use of Personnel Protective Equipment's and to follow proper gowning procedure during any activity in the laboratory.

+ To ensure timely completion of assigned Training Modules and Skill Evaluation.

+ To involve in Technical discussions / Presentations.

+ Strong knowledge of cGMP, GLP and GDP procedures with good attention to details skills.

+ Effective vendor communication and negotiation skills are mandatory.

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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