Executive, QC Instrumentation
Amneal Pharmaceuticals · Ahmedabad
Description:
This role is responsible for managing, calibrating, and maintaining quality control instrumentation and equipment in compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent ensures that all quality control instruments are properly calibrated, qualified, and maintained to support accurate and reliable analytical testing. The position identifies instrumentation issues and takes proactive measures to prevent potential equipment failures that could impact product quality or testing reliability.
It applies knowledge of instrument qualification, calibration standards, and regulatory frameworks to maintain a compliant instrumentation program. The role audits and monitors instrumentation performance and maintenance activities against both internal and regulatory standards to uphold compliance. It supports the qualification and validation of new instruments and equipment introduced into the quality control laboratory.
The position reports instrumentation deviations and equipment failures to the appropriate quality and maintenance stakeholders. It supports the organization's commitment to maintaining a reliable and compliant instrumentation infrastructure that underpins quality control operations.
Essential Functions:
- Manage, calibrate, and maintain quality control instrumentation and equipment in accordance with established specifications and regulatory requirements
- Ensure all quality control instruments are properly calibrated, qualified, and maintained to support accurate and reliable analytical testing
- Identify instrumentation issues and implement preventive measures to avoid potential equipment failures impacting product quality or testing reliability
- Apply knowledge of instrument qualification, calibration standards, and regulatory frameworks to maintain a compliant instrumentation program
- Audit and monitor instrumentation performance and maintenance activities against defined internal and regulatory quality standards
- Support the qualification and validation of new instruments and equipment introduced into the quality control laboratory
- Report instrumentation deviations and equipment failures to relevant stakeholders in a timely manner
- Contribute to process improvement initiatives by identifying opportunities to enhance instrumentation management and calibration programs
- Maintain accurate and complete documentation of all instrumentation activities in compliance with GMP and GLP requirements
Additional Responsibilities:
- Perform daily verification of instruments (e.g., pH meter, conductivity meter, balance, TOC).
- Prepare and execute planners for calibration, preventive maintenance, and Computer System Validation (CSV)
- Manage procurement and inventory of instrument spares and PM kits.
- Manage procurement and inventory of reference standard, chemicals and HPLC/GC columns.
- Initiate CCFs, prepare URS and QRM documents, and support vendors during IQ, OQ, and PQ qualification activities.
- Participate in and support investigations related to Out of Specification (OOS), Out of Alert Limit (OOAL), deviations, and incidents.
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