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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: - Bachelor's degree in Mechanical / Biomedical / SW /HW Engineering, Quality Assurance, Regulatory Affairs, or a related field. - Experience: 3-5+ years of experience in validation within the medical device industry, with a focus on IQ, OQ, and PQ activities. - Regulatory Knowledge: Strong understanding of medical device regulations, including FDA 21 CFR Part 820 and ISO 13485. - Validation Expertise: In-depth knowledge of validation methodologies, including IQ, OQ, and PQ for equipment, utilities, and processes. - Risk Management: Familiarity with risk assessment methodologies (e.G., FMEA) and their application in validation activities. - Communication Skills: Excellent written and verbal communication skills to effectively convey information to internal and external stakeholders, including auditors and regulatory agencies. - Analytical and Problem-Solving Skills: Strong analytical abilities to identify gaps, interpret data, and propose effective solutions. - Attention to Detail: Meticulous attention to detail for reviewing documentation and ensuring compliance. - Teamwork and Collaboration: Proven ability to work effectively in a cross-functional team environment. - Documentation Skills: Proficiency in creating and reviewing technical documentation, protocols, and reports. - Software Proficiency: Familiarity with relevant software tools and platforms used in validation activities (e.G., Quality Management Systems, statistical analysis software). Qualifications & Skills - Education: Bachelor's degree in Biomedical, Mechanical, Software, or Hardware Engineering, or in Regulatory Affairs or Quality Assurance. - Experience: 5–10 years in medical device risk assessment, validation, or DHF remediation. Technical Proficiency: - ISO 14971, ISO 13485, FDA 21 CFR Part 820 - Tools like DOORS, Polarion, TrackWise, SAP PLM - Familiarity with AI/ML-based SaMD and cybersecurity frameworks 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 - **Irrelevant profiles will not be considered for this opportunity.
