To lead a team responsible for Instrument validation activities at the site in accordance with the System Life Cycle (SLC) requirements as per the written procedures.
Responsible for team to deliver through generation, execution and review qualification and validation studies according to approved protocols and SOPs.
Responsible to investigate and troubleshoot problems and determine solutions or recommendations for changes and improvements, including expanding facilities and upgrading equipment and software.
Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
Participate to the regulatory vigilance (USFDA, MHRA audits etc.,) and QMS maintenance for Commissioning & Qualification (compliance to regulations and corporate quality system).
Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
Coaching and Developing Others – Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.
Scheduling Work and Activities – Scheduling events, programs, and activities, as well as the work of others.
Monitoring and Controlling Resources- Coordinating the Work and Activities of Others – Getting members of a group to work together to accomplish tasks.
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