Site Quality Head

3 weeks ago


Guwahati, Assam, India SUN PHARMA Full time

Job Summary

Sun Pharma is seeking a highly skilled Site Quality Head to lead our quality management efforts at our site. As a key member of our team, you will be responsible for ensuring the supply of high-quality, GMP-compliant products and defining operational strategy for quality system management.

Key Responsibilities

  1. Assess quality issues at the site and ensure compliance to QA/QC regulatory requirements in manufacturing operations.
  2. Design and implement quality-related SOPs, policies, and standards, ensuring compliance to all quality systems at the site.
  3. Drive continuous improvement initiatives to enhance compliance, drive efficiencies, and cost-effectiveness.
  4. Ensure availability of adequate resources, including manpower, to maintain compliance with GXP requirements.
  5. Facilitate harmonization and consistent implementation of Quality Systems and procedures at the site, in alignment with Global Quality policies and standards.
  6. Investigate market complaints, failures, and deviations, and implement corrective and preventive actions with adherence to timelines.
  7. Ensure all-time readiness of the site for regulatory agency inspections and internal audits, and implement corrective actions regarding observations made by the agencies or internal audit teams.
  8. Monitor industry trends and issues faced internally, and identify scope for improving Site quality management and processes.
  9. Ensure compliance to regulatory requirements on product, process, and release procedures.
  10. Prepare site quality revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.
  11. Ensure release of safe and effective drug products from the site as per cGMP requirements and regulatory commitment.
  12. Collaborate with all Sun Pharma sites and functions to leverage synergies.

Requirements

Science and Pharmacy Graduates or Equivalent, 20+ years in a pharmaceutical quality management leadership role experience preferred.

Success Attributes

  • Knowledge of GxP's, cGMP, and other regulatory requirements.
  • Planning and Prioritization.
  • Collaboration, Accountability, Compliance, Customer Service orientation.
  • People Connect, Attention to detail, Emotional control, Effective Communication, Problem-solving.


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