Site Quality Director
1 month ago
Job Title: Site Quality Head
Job Summary:
As a Site Quality Head at Sun Pharma, you will be responsible for ensuring the supply of high-quality, GMP-compliant products and defining the operational strategy for quality system management at the site. You will finalize site quality assurance and control goals, objectives, and strategies in line with Sun Pharma compliance, product quality management objectives, and regulatory requirements.
Key Responsibilities:
- Quality Compliance: Assess quality issues at the site and ensure compliance to QA/QC regulatory requirements in manufacturing operations at the site and track quality metrics with site manufacturing management and drive them down.
- SOP Development and Implementation: Design and implement, and ensure compliance to all quality-related SOPs, Policies, Standards, and Quality systems at the site.
- Continuous Improvement: Design and execute continuous improvement initiatives at the site to enhance compliance, drive efficiencies, and cost-effectiveness.
- Resource Management: Ensure the availability of adequate resources, including manpower to maintain compliance with GxP requirements.
- Quality Systems Harmonization: Facilitate harmonization and consistent implementation of Quality Systems and procedures at the site, in alignment with Global Quality policies and standards.
- Complaints and Deviations: Ensure market complaints, failures, deviations are investigated, and corrective and preventive actions are implemented with adherence to timelines.
- Regulatory Readiness: Assure all-time readiness of the site for regulatory agency inspections and internal audits and appropriate implementation of corrective actions regarding observations made by the agencies and internal audit teams.
- Industry Trends and Process Improvement: Monitor industry trends and issues faced internally and identify scope for improving site quality management and processes.
- Product Release: Ensure release of safe and effective drug products from the site as per cGMP requirements and regulatory commitment.
- Inter-Site Collaboration: Ensure smooth collaboration with all Sun Pharma sites and functions to leverage synergies.
- Compliance and EHS: Follow the EHS policy, laboratory standard operating procedures, and maintain compliance to GMP requirements.
Requirements:
- Education: Science and Pharmacy Graduates or Equivalent
- Experience: 20+ years in a pharmaceutical quality management leadership roles experience preferred. Should be in a similar role currently
- Attributes:
- GxP's, cGMP, and regulatory requirements.
- Planning and Prioritization
- Collaboration, Accountability, Compliance, Customer Service orientation
- People Connect, Attention to detail, Emotional control, Effective Communication, Problem-solving
Delegation of Responsibility:
In the absence of the job holder, delegation of responsibility will be as follows:
Upward Delegation – Strategic site responsibilities to a higher level
Downward Delegation – Operational responsibilities to direct reports or similar job role
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