Qualification Expert

Novartis is hiring a Qualification Expert in Hyderabad, India. Level rates it ; you can apply on Novartis.

Level's read on this job

On Level's scale, this role is Little AI ●○○○: aI is not part of the work.
Level classes it as a senior role.
Novartis has 853 other open roles on Level.
Posted in the last few days.

AI in this role

Job Description Summary

Provide end-to-end technical ownership and coordination of analytical/laboratory instrument qualification projects to ensure laboratory equipment is fit for intended use and appropriately qualified before GMP/GxP release, with qualification documentation demonstrating conformance to predefined user requirements. This includes associated software-validation activities where applicable.
The Qualification Expert acts as the technical qualification specialist connecting all internal stakeholders

Job Description

Key Responsibities:

Develop and implement qualification strategies and plans for laboratory instruments and equipment, ensuring activities are aligned with applicable GMP requirements, internal procedures, and the intended use of the equipment.
Perform risk assessments and equipment classification to determine the appropriate qualification approach and define the required level of testing and documentation based on instrument criticality and GMP impact.
Lead the preparation and review of User Requirements Specifications (URS), ensuring that business, technical, compliance, and data integrity requirements are clearly defined and traceable throughout the qualification lifecycle.
Develop, review, coordinate, and execute qualification protocols, including IQ, OQ, and PQ activities, and ensure that deviations, observations, acceptance criteria, and qualification results are appropriately documented and resolved.
Support the qualification of computerized laboratory instruments and associated software, ensuring that system functionality, interfaces, access controls, electronic records, and applicable data integrity requirements are adequately addressed.
Maintain requirements traceability and qualification reporting, ensuring that qualification evidence demonstrates that user requirements have been successfully verified and that equipment is suitable for its intended use.
Coordinate qualification activities with vendors, service providers, engineering, laboratory users, QA, maintenance, and calibration teams, including management of changes, requalification requirements, periodic reviews, and lifecycle activities.
Maintain oversight of the instrument inventory and qualification status throughout the equipment lifecycle, ensuring continued qualified status through calibration and maintenance interfaces and supporting equipment retirement and decommissioning when required.

Essential Requirements

7+ years overall experience in pharmaceutical/biopharmaceutical laboratory equipment qualification, validation or engineering.
5+ years hands-on qualification experience in GMP/GxP environments.
Demonstrated independent experience qualifying both conventional laboratory equipment and computerized analytical systems.
Bachelor's or Master's degree in Instrumentation Engineering, Electronics/EEE, Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Analytical Chemistry, Biotechnology, Chemical Engineering, or a closely related technical/scientific discipline.
Knowledge of GAMP-based computerized-system concepts is also highly desirable because the laboratory-equipment qualification procedure explicitly addresses GAMP software categories in configuration/qualification considerations.

Skills Desired

Design of Experiments (DOE), Environment Health and Safety, Environment Management, Laboratory Instrumentation, Manufacturing Processes, Materials Science, Process Simulation, Standard Operating Procedure (SOP), Technical Writing, Waterfall Model

How we rate this

Qualification Expert at Novartis rates 38 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.