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Deputy Manager

3 months ago

Bengaluru, Karnataka, India Biocon Full time

RESPONSIBILITIES:
A. 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 behaviour at all times.
B

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.
C

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.
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