Ext Quality Mgt & Supplier Compliance Specialist

Overview

Own external quality management and supplier compliance activities for Zentiva, covering third-party lifecycle, supplier audits, quality agreements, supplier risk and CAPA follow-up in a GxP environment.

What you'll do

• Create and maintain Third Party records in Quality Forward and initiate and manage TP lifecycle change controls.
• Support supplier onboarding, qualification, updates, suspensions and discontinuations.
• Maintain supplier qualification documentation and records, ensuring completeness, accuracy and traceability.
• Create and coordinate supplier audit requests, execute paper assessments and desktop supplier evaluations.
• Support planning, scheduling and coordination of supplier audits and maintain audit documentation and records.
• Support closure of audit observations and actions.
• Prepare, revise and maintain Quality Technical Agreements (QTAs), route them to relevant stakeholders and track execution, renewals and periodic reviews.
• Support resolution of comments received from suppliers, affiliates and sites during QTA review and approval.
• Execute Supplier Risk Ranking Tools (RRTs), collect and evaluate supplier performance, compliance and risk information, and maintain risk assessment records in Quality Forward.
• Escalate high-risk suppliers or significant compliance concerns.
• Track CAPAs resulting from supplier audits, paper assessments and supplier quality issues, and follow up with suppliers and stakeholders on overdue CAPAs.
• Maintain CAPA supporting documentation, evidence and metrics, support effectiveness verification, and coordinate collection and review of CAPA evidence.
• Escalate overdue CAPAs and recurring findings to the Manager.
• Maintain supplier records and documentation in Quality Forward, ensuring data integrity, and support generation of reports, metrics and dashboards.
• Prepare supplier qualification packages and audit documentation for inspections and support responses to supplier-related audit observations.
• Ensure compliance with GMP requirements and corporate procedures.
• Support harmonization and standardization of supplier quality processes and participate in process improvement and digitalization initiatives.

What you'll need

• Technical university degree.
• 4 to 8 years of industry experience specifically in GxP.
• Strong exposure to supplier qualification, third party management, supplier auditing, quality agreements, GMP compliance, risk assessment methodologies and outsourced activity management.
• Experience performing or supporting supplier audits and paper assessments.
• Strong understanding of supplier qualification processes, supplier risk management and CAPA management.
• Good knowledge of GMP, GDP, quality systems and Health Authority expectations.
• Strong analytical, problem-solving and risk-based decision-making skills.
• Ability to operate effectively in a cross-functional, matrix environment.
• Strong written and verbal communication skills in English.
• Strong capacity for working independently with minimal supervision.
• Ability to make and communicate difficult decisions.
• Self-awareness and willingness to further develop own strengths and explore opportunities for improvement.

Nice to have

• Health, pharma, technical or chemical degree area.
• Experience with Quality Forward, eQMS systems, supplier quality databases and audit management tools.

Details

• Location: Ankleshwar, India.