Ext Quality Mgt & Supplier Compliance Specialist

Zentiva; Ankleshwar; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Zentiva in India (Gujarat) seeks an Ext Quality Mgt & Supplier Compliance Specialist to manage third party lifecycle, supplier qualification, audits and quality agreements within a GMP-compliant framework.

The role supports risk assessment, CAPA follow-up, and KPI reporting, coordinating with suppliers and internal teams to ensure compliance and continuous improvement across supplier quality processes.

Qualifications

• 4 to 8 years industry experience in GxP with supplier management.
• Experience in third party management, supplier audits, and quality agreements.
• Familiarity with GMP compliance and risk assessment methodologies.

Responsibilities

• Third Party Lifecycle Management
• Create and maintain Third Party records in Quality Forward
• Initiate and manage TP lifecycle change controls
• Support supplier onboarding, qualification, updates, suspensions and discontinuations
• Maintain supplier qualification documentation and records
• Audit Coordination & Assessments
• Create and coordinate supplier audit requests
• Execute paper assessments and desktop supplier evaluations
• Support planning, scheduling and coordination of supplier audits
• Maintain audit documentation and records
• Support closure of audit observations and actions
• Quality Agreement Management
• Prepare, revise and maintain Quality Technical Agreements (QTAs)
• Track QTA execution, renewals and periodic reviews
• Support resolution of comments received during QTA review
• Support discussions and resolution of comments received from suppliers, affiliates and sites during QTA review and approval process
• Supplier Risk Management
• Execute Supplier Risk Ranking Tools (RRTs)
• Collect and evaluate supplier performance, compliance and risk information
• Maintain risk assessment records within Quality Forward
• Escalate high-risk suppliers or significant compliance concerns
• CAPA Management & Follow-up
• Track CAPAs resulting from supplier audits, paper assessments and supplier quality issues
• Follow up with suppliers and stakeholders on overdue CAPAs
• Maintain supporting documentation and evidence related to CAPA completion
• Support effectiveness verification activities
• Maintain CAPA metrics and status reports
• Coordinate collection and review of CAPA evidence from suppliers arising from audits, paper assessments and supplier quality events
• Escalate overdue CAPAs and recurring findings to the Manager for further action
• Quality Forward Administration
• Maintain supplier records and associated documentation in Quality Forward
• Ensure data integrity and completeness of documentation
• Support generation of reports, metrics and dashboards
• Inspection Readiness & Compliance
• Prepare supplier qualification packages and audit documentation for inspections
• Support responses to supplier-related audit observations
• Maintain inspection-ready documentation and records
• Ensure compliance with GMP requirements and corporate procedures
• Support generation of supplier qualification, audit, CAPA and risk management KPIs and dashboards
• Continuous Improvement
• Support harmonization and standardization of supplier quality processes
• Participate in process improvement and digitalization initiatives
• Contribute to lessons learned activities arising from audits and supplier performance reviews

Skills

GxP experience

Supplier qualification

Audit coordination

Quality agreements

Risk assessment

CAPA management

Documentation control

Education

Technical University Degree

Tools

Quality Forward

Job description

Job Title : Ext Quality Mgt & Supplier Compliance Specialist

Required Qualifications, Experience & Skills

• Technical University Degree (health, pharma, technical, chemical areas are advantage)

4 to 8 years industry experience specifically in GxP with a strong exposure to Supplier qualification, Third Party Management, Supplier auditing, Quality Agreements, GMP compliance, Risk assessment methodologies & Outsourced activity management.

Main Accountabilities And Duties

• Third Party Lifecycle Management
• Create and maintain Third Party records in Quality Forward.
• Initiate and manage TP lifecycle change controls.
• Support supplier onboarding, qualification, updates, suspensions and discontinuations.
• Maintain supplier qualification documentation and records.
• Ensure completeness, accuracy and traceability of TP records.
• Audit Coordination & Assessments
• Create and coordinate supplier audit requests.
• Execute paper assessments and desktop supplier evaluations.
• Support planning, scheduling and coordination of supplier audits.
• Maintain audit documentation and records.
• Support closure of audit observations and actions.
• Quality Agreement Management
• Prepare, revise and maintain Quality Technical Agreements (QTAs).
• Ensure QTA templates are completed accurately and routed to relevant stakeholders.
• Track QTA execution, renewals and periodic reviews.
• Support resolution of comments received during QTA review.
• Support discussions and resolution of comments received from suppliers, affiliates and sites during QTA review and approval process.
• Supplier Risk Management
• Execute Supplier Risk Ranking Tools (RRTs).
• Collect and evaluate supplier performance, compliance and risk information.
• Maintain risk assessment records within Quality Forward.
• Escalate high-risk suppliers or significant compliance concerns.
• CAPA Management & Follow-up
• Track CAPAs resulting from supplier audits, paper assessments and supplier quality issues.
• Follow up with suppliers and stakeholders on overdue CAPAs.
• Maintain supporting documentation and evidence related to CAPA completion.
• Support effectiveness verification activities.
• Maintain CAPA metrics and status reports.
• Coordinate collection and review of CAPA evidence from suppliers arising from audits, paper assessments and supplier quality events.
• Escalate overdue CAPAs and recurring findings to the Manager for further action
• Quality Forward Administration
• Maintain supplier records and associated documentation in Quality Forward.
• Ensure data integrity and completeness of documentation.
• Support generation of reports, metrics and dashboards.
• Inspection Readiness & Compliance
• Prepare supplier qualification packages and audit documentation for inspections.
• Support responses to supplier-related audit observations.
• Maintain inspection-ready documentation and records.
• Ensure compliance with GMP requirements and corporate procedures.
• Support generation of supplier qualification, audit, CAPA and risk management KPIs and dashboards.
• Continuous Improvement
• Support harmonization and standardization of supplier quality processes.
• Participate in process improvement and digitalization initiatives.
• Contribute to lessons learned activities arising from audits and supplier performance reviews.

QUALITY

• Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.

HSE

• Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.

PHARMACOVIGILANCE

• All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations.

COMPLIANCE*

• ) country specific
• The employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents.

SUSTAINABILITY

• Adheres to the principles of ESG detailed in the Sustainability Strategy and its 3 pillars People, Partners and the Planet