Investigation and Deviation Specialist
3 weeks ago
Key Role: Investigation and Deviation Expert This role is responsible for managing deviations, conducting root cause analysis, and implementing corrective actions to ensure compliance with quality standards. The successful candidate will work collaboratively with cross-functional teams to identify and resolve issues. Responsibilities: Manage deviations in the 1QEM system for assigned sites. Conduct thorough investigations of deviations, complaints, and OOXs. Implement corrective actions, preventive measures, and quality improvements based on investigation findings. Collaborate with site SPOCs, production units, quality assurance, and engineering teams to ensure effective communication and resolution of issues. Develop, revise, and maintain high-quality documentation related to deviation management processes, ensuring alignment with regulatory requirements. Track and report metrics related to change control documentation, including timeliness, compliance, and quality. Support periodic reviews of the quality management system (QMS) to identify areas for improvement. Requirements: Essential Skills: Quality / Accuracy / Right First Time Timeliness Deviations / Escalations Quality System Management (Change Control, CAPA, Risk Assessment, and EC) Desirable Requirements: Professional Competencies: cGMP and Good Documentation Practices Deviation Handling Root Cause Analysis (RCA) Corrective Action and Preventive Action Change Control Management Knowledgeable on Effectiveness Checks Continuous Process Improvement Drug Substance Manufacturing Process Design and Control Gap Assessment and Risk Analysis Complaints and OOXs Handling Technology Transfer Report writing Data Analytics Project Management Education: Bachelor's degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams. Languages: English (oral and written). Experiences: Minimum 12 years of experience in MS&T, Quality Assurance, Regulatory or in the manufacturing of Biologics in large molecules. At least 5 years of experience in MS&T or Manufacturing operations.
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Specialist - MS&T (Investigations & Deviations)
3 weeks ago
Hyderabad, India Novartis Full timeJob Description Summary The purpose of the investigation and deviation Specialist role is to work collaboratively with process experts and multifunctional operations teams in Radio Ligand Therapy (RLT) platform sites, taking ownership of deviation management for the site. The individual will actively participate in investigations of deviations, complaints,...
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Specialist - MS&T (Investigations & Deviations)
3 weeks ago
Hyderabad, India Novartis Full timeJob Description SummaryThe purpose of the investigation and deviation Specialist role is to work collaboratively with process experts and multifunctional operations teams in Radio Ligand Therapy (RLT) platform sites, taking ownership of deviation management for the site. The individual will actively participate in investigations of deviations, complaints,...
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Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 24,00,000 per yearSummaryThe purpose of the investigation and deviation Specialist role is to work collaboratively with process experts and multifunctional operations teams in Radio Ligand Therapy (RLT) platform sites, taking ownership of deviation management for the site. The individual will actively participate in investigations of deviations, complaints, and OOXs by...
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Specialist, IT Problem and Quality Deviations
2 weeks ago
Hyderabad/ Secunderabad, India Bristol Myers Squibb Full time ₹ 40,00,000 - ₹ 80,00,000 per yearJob Description Working with Us Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work...
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Hyderabad, India Novartis Full timeJob Description Summary The purpose of the investigation and deviation expert role is to work collaboratively with process experts and multifunctional operations teams in Radio Ligand Therapy (RLT) platform sites, taking ownership of deviation management for the site. The individual will actively participate in investigations of deviations, complaints, and...
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Hyderabad, India Novartis Full timeJob Description SummaryThe purpose of the investigation and deviation expert role is to work collaboratively with process experts and multifunctional operations teams in Radio Ligand Therapy (RLT) platform sites, taking ownership of deviation management for the site. The individual will actively participate in investigations of deviations, complaints, and...
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Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 24,00,000 per yearSummaryThe purpose of the investigation and deviation expert role is to work collaboratively with process experts and multifunctional operations teams in Radio Ligand Therapy (RLT) platform sites, taking ownership of deviation management for the site. The individual will actively participate in investigations of deviations, complaints, and OOXs by...
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Investigations Specialist
1 hour ago
Hyderabad, Telangana, India Google Full time ₹ 12,00,000 - ₹ 36,00,000 per yearMinimum qualifications:Bachelor's degree or equivalent practical experience in investigations.6 years of experience leading security investigations involving threat mitigation, investigative interviewing, or risk analysis that impact end users across multiple regions. 4 years of experience analyzing, interpreting, and drawing solutions from data, as it...
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Investigations Specialist
1 week ago
Hyderabad, Telangana, India Google Full time ₹ 12,00,000 - ₹ 36,00,000 per yearNote: By applying to this position you will have an opportunity to share your preferred working location from the following: Bengaluru, Karnataka, India; Gurgaon, Haryana, India; Hyderabad, Telangana, India.Minimum qualifications:Bachelor's degree or equivalent practical experience in investigations.6 years of experience leading security investigations...
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Investigation Specialist, ROW IB
7 days ago
Hyderabad, Telangana, India Amazon Full time ₹ 4,00,000 - ₹ 8,00,000 per yearDESCRIPTIONROW IB team is seeking a highly motivated Investigation Specialist to help manage daily operational activities centrally across INFCs. Our teams' objective is to provide the accurate resolution to all the sellers and fulfillment centres. This is a chance to work in an innovative team, participating in operational excellence, system support,...
