Quality Assurance Technical Manager

Looking for Immediate joiners - From 3+ to 10 yrs : -

Key responsibilities

• Validation Gap Analysis : Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.G., FDA 21 CFR Part 820, ISO 13485) and industry best practices.
• Deviation Investigation and Resolution : Investigate deviations encountered during IQ, OQ, and PQ processes, determine root causes, and recommend corrective and preventive actions (CAPAs).
• Protocol and Reports Review : Review IQ, OQ, and PQ protocols and reports for equipment, utilities, and facilities, ensuring adherence to regulatory and internal requirements.
• Cross-Functional Collaboration : Collaborate with engineering, production, quality assurance, and other teams to coordinate qualification activities and ensure successful project outcomes.
• Documentation and Record Management : Review complete validation documentation, including risk / impact assessments, change-control records, and deviation reports.
• Continuous Improvement : Identify and propose remediation actions for existing and potential validation issues, driving continuous improvement initiatives.
• Staying Current : Check for up-to-date validation requirements, best practices, and industry trends related to medical device IQ, OQ, and PQ.

Qualifications / JD :

Qualifications & Skills

T echnical Proficiency :

If interested, please share the resume to prasena.kumargp@hcltech.com along with below required details.

Experience -

CTC-

Notice Period-

Native -

Current Location -

Regards

PrasenakumarGP

Note -