Biocon - Deputy Manager

RESPONSIBILITIES:

STRATEGY:

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

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

- Ensure all-time inspection readiness.

- Showcase high standards of integrity and ethical behavior at all times.

OPERATIONS:

- Quality management systems:

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

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

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

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

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

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

- Manage and control documentation.

- 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.

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

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

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

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

- General:

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

- Support regulatory inspections and customer/partner audits.

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

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

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

- Comply with all organizational statutory compliance requirements.

PEOPLE:

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

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

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

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