JOB DESCRIPTION:
Primary Job Function:
- This position is responsible for managing Quality Systems related initiatives within the EPD Quality System organization to ensure safe, effective and quality products can be supplied in accordance with regulatory and business requirements.
- This position is responsible for managing Quality Questionnaires, related to Suppliers and Third-Party Manufacturers.
Core Job Responsibilities:
- Manage Quality Questionnaire program for EPD suppliers and Third-Party Manufacturers including scheduling and execution.
- Reviewing Quality Questionnaires returned by the Suppliers/TPMs to ensure accuracy.
- Collaborate with relevant Supplier/TPM QA teams for evaluation and completion of Quality Questionnaires.
- Create and maintain documentation, data, and tracking systems to support efficient document management processes.
- Act as a Subject Matter Expert for assigned Quality Systems.
- Maintain an excellent understanding of actual and future regulatory expectations for EPD products and provide support for transition into the Business Unit as required.
- Leads global initiatives and works with the Business Units to coordinate activities and ensure implementation.
- Participate on QA cross-functional teams as necessary.
- Provide leadership as a Process Owner of assigned Quality process in line with the EPD Quality System Framework & Governance.
Supervisory/Management Responsibilities:
Position Accountability/Scope:
- Reports to Senior Manager QA - EPD Quality Systems & Strategy
Minimum Education:
- Required: Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, or other technical/scientific area.
Minimum Experience/Training Required:
- 5-8 years experience in the pharmaceutical or medical device industry.
- Knowledge of relevant quality system regulations and compliance standards.
- Strong communication skills for timely, sensitive information sharing. Advanced written and verbal in Business English.
- Ability to lead, influence, and collaborate with internal and external stakeholders.
- Skilled in analyzing quality data to drive strategic action plans.
- Familiar with quality improvement programs, metrics trending, and data analytics.
- Proficiency in MS Office suite of tools such as Microsoft Excel, PowerPoint, Visio, Adobe Acrobat.
- Strong Leadership, project management and troubleshooting skills to drive resolution of complex issues.
- Experience with identifying Quality issues and implementing Corrective and Preventive actions.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EPD Established Pharma
LOCATION:
India Mumbai : BKC Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
