Senior Manager, Quality Assurance Specialist

Bristol Myers Squibb

6 - 11 years

8 - 12 Lacs

hyderabad

Posted:-1 days ago| Platform:

Apply

Skills Required

quality control iso ich-gcp guidelines regulatory regulatory compliance pharmacovigilance root cause analysis regulatory requirements ich assurance quality management kyc clinical research quality assurance qms regulatory affairs inspection

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.

More Jobs at Bristol Myers Squibb

Medical Science Liaison - Haematology & Oncology (Field based in Bangalore)

Bengaluru, Karnataka

Experience: Not specified

Salary: Not disclosed

Senior Specialist, Inventory Planning & Coordination

Hyderabad, Telangana, India

2 - 5 yrs

Salary: Not disclosed

Manager I, R2R Operations

Hyderabad, Telangana, India

8 - 8 yrs

Salary: Not disclosed

Specialty Care Advisor (Field Based in Cochin)

Trivandrum, Kerala, India

10 - 10 yrs

Salary: Not disclosed

Sr. Manager, Risk Management and Central Monitoring

Hyderabad

5 - 10 yrs

INR 13 - 18 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.