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Ankleshwar, Gujarat, India
Onsite
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.
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.
Experience with Quality Forward, eQMS systems, supplier quality databases and audit management tools is highly desirable.
Ability to work effectively in a matrix cross-functional environment.
Strong capacity for working independently with minimal supervision.
Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills. (English language in writing and speaking)
Self-awareness, willingness to further develop own strengths and explore opportunities for improvement.
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.
OTHER RESPONSIBILITIES
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
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