Biocon - Deputy Manager - Certified Quality Auditor

RESPONSIBILITIES:

A. STRATEGY

1. Perform all activities in support of Biocon Biologics Core Values and demonstrate strong and visible support for the values.

2. Identify opportunities to enhance existing processes for value creation through innovation.

3. Ensure all-time inspection readiness.

4. Showcase high standards of integrity and ethical behaviour at all times.

B. OPERATIONS:

Quality management systems:

1. Prepare, review, implement, and manage global standards and operating procedures.

2. Collaborate with department representatives and stakeholders to understand and finalize specific needs for harmonization.

3. Perform gap analysis on existing procedures and quality systems, identify redundancies, and streamline processes.

4. Establish and implement harmonized global processes and procedures conforming to applicable GXP regulations, regulatory requirements, and industry best practices.

5. Coordinate with department representatives and stakeholders to implement changes in requirements.

6. Ensure compliance with established policies and procedures, as applicable.

7. Manage and control documentation.

8. Initiate, review, and track change control, events/deviations, and corrective/preventive actions, arising from changes to standards and procedures, audit and inspection findings, consultant inputs, pharmacopeial updates, and organization changes.

9. Monitor, review, and analyse key quality and performance indices.

10. Coordinate, manage, document, and track Quality Management Reviews.

11. Support the development and implementation of enterprise IT systems related to Quality.

12. Support the quality management requirements for medical devices and coordinate the certification/recertification through certifying agencies.

General:

1. Ensure escalation and communication of identified Critical and Major findings, Trends, and Risks.

2. Support regulatory inspections and customer/partner audits.

3. Build and integrate the risk-based approach into the quality management system.

4. Adhere to principles of Environment, Safety, and Health and contribute towards a safe workplace.

5. Perform any other administrative duties assigned on time in full.

6. Comply with all organizational statutory compliance requirements.

C. PEOPLE:

1. Champion the organizational core values and ensure that all interactions promote a positive culture for collaboration, teamwork, and mutual respect.

2. Act as a member of the team and strive towards achieving success in both departmental and individual goals in a quality-compliant manner.

3. Communicate to collaborate and ensure healthy working relations with all business customers and process stakeholders including cross-functional teams.

4. Through every interaction, promote an organizational culture for quality beyond compliance.