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Bristol Myers Squibb
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Senior Manager, Quality Assurance Specialist

Senior Manager, Quality Assurance Specialist

Bristol Myers Squibb

7 - 12 years

11 - 16 Lacs

hyderabad

Posted:2 weeks ago| Platform:

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Skills Required

rca data analysis manager quality assurance operational excellence process improvement trend analysis clinical trials business strategy risk management continuous improvement

Work Mode

Work from Office

Job Type

Full Time

Job Description

Identify opportunities for process improvements by analyzing current workflows, systems, and procedures related to CAPA management.

Lead cross-functional teams to drive process improvement projects from inception to completion.
Manage the CAPA process, including the identification, investigation, and resolution of non-conformances.

Act as a CAPA lead investigator to conduct and manage root cause analysis, perform impact assessment of GCP deviations, audits (investigator sites, protocols, process, vendors, systems, and others as required), inspections, quality events and serious breaches.
Act as a subject matter expert (SME) to support the business develop robust CAPAs with adequate effectiveness checks resulting from deviations, audits (investigator sites, protocols, process, vendors, systems, and others as required), inspections, quality events and serious breaches.

Presents investigation findings to key stakeholders across Global Drug Development (GDD) and/or Global Quality (GQ) and works with the business to track CAPAs & effectiveness checks (where relevant) to completion.
Provide training and support to staff on process improvement methodologies and CAPA management.
Monitor the effectiveness of implemented CAPAs and process improvements through data analysis and performance metrics.

Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, to drive continuous improvement, and to streamline processes

Stay current with industry best practices and regulatory requirements related to process improvement and CAPA management.
Develops CAPA metrics and trend analysis to identify areas of improvement and drive continuous improvement.

Prepare and present reports on process improvement activities and CAPA status to senior management.

Serve as the Infinity system superuser and provide training to users, as needed.
Maintains strong and productive working relationships with key stakeholders throughout BMS with the ability to think enterprise wide.
Fosters Teamwork and Inclusion: Practices inclusion and seeks different perspectives. Builds effective teams committed to organizational goals; fosters inclusion and collaboration among teams to address relevant issues.
Commitment to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluates products, processes and/or services against those standards; manages quality.
Recognize Global Implications and diversity: Seeks to understand issues, trends and perspectives of various cultures and countries; recognizes that what works in one s own country will not necessarily work in another; addresses cultural and geographic differences in strategies and approaches.
Demonstrates Adaptability: Handles day-today work challenges confidently; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; show resilience in the face of constraints, frustrations or adversity; demonstrates flexibility.
Analysis of Issues: Gathers relevant information systematically; considers a broad range of issues or factors; grasps complexities and perceives relationships among problems or issues; seeks input from others; uses accurate logic in analyses.
Innovation: Generates new ideas; goes beyond the status quo; recognizes the need for new of modified approaches; brings perspectives and approaches together combining them in creative ways. Other:

Qualifications & Experience

B. S. and/or M. S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
Minimum 7+ years GxP CAPA Management in Quality, Clinical Development or Regulatory Compliance.
Advanced Finding Investigation and Root Cause Analysis (RCA) proficiency.

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Bristol Myers Squibb

Pharmaceutical Manufacturing

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Senior Manager, Quality Assurance Specialist