Site Quality Head
3 weeks ago
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
- Assess quality issues at the site and ensure compliance to QA/QC regulatory requirements in manufacturing operations.
- Design and implement quality-related SOPs, policies, and standards, ensuring compliance to all quality systems at the site.
- Drive continuous improvement initiatives to enhance compliance, drive efficiencies, and cost-effectiveness.
- Ensure availability of adequate resources, including manpower, to maintain compliance with GXP requirements.
- Facilitate harmonization and consistent implementation of Quality Systems and procedures at the site, in alignment with Global Quality policies and standards.
- Investigate market complaints, failures, and deviations, and implement corrective and preventive actions with adherence to timelines.
- 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.
- Monitor industry trends and issues faced internally, and identify scope for improving Site quality management and processes.
- Ensure compliance to regulatory requirements on product, process, and release procedures.
- Prepare site quality revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.
- Ensure release of safe and effective drug products from the site as per cGMP requirements and regulatory commitment.
- 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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