We are looking for an QA Third-Party Management Senior Specialist.
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The QA Third Parties Management Senior Specialist is responsible for ensuring that quality oversight of outsourced GMP activities is effectively planned, implemented, and maintained in compliance with applicable regulations, contractual requirements, and internal standards.
He/she provides Quality oversight throughout the third-party lifecycle, ensuring that external partners' quality systems, processes, and deliverables are adequately assessed, qualified, monitored, and maintained over time, and that the compliant state of outsourced activities is clearly defined, documented, and sustained.
Responsibilities:
Ensures that quality oversight of third‐party manufacturers and service providers involved in GMP activities is defined, implemented and maintained in compliance with applicable GxP regulations and internal requirements
Ensures alignment of third‐party quality management activities with corporate‐level policies, standards and governance models defined by the Company
Manages the qualification lifecycle of third‐party sites and critical service providers involved in manufacturing, packaging, testing, storage, distribution and other GMP‐relevant outsourced activities
Ensures that third‐party qualification activities are supported by documented, risk‐based assessments and are periodically reviewed
Defines, reviews, negotiates and approves Quality Technical Agreements (QTAs) and related quality documentation with third‐party contractors
Acts as the primary QA interface between the Company and third‐party contractors for all quality‐related matters
Supports the organization and management of the audit program for third‐party manufacturers and critical service providers, including planning, execution, reporting and follow‐up of corrective and preventive actions
Participates in external audits of third‐party sites as QA representative and qualified auditor, where applicable
Monitors the ongoing GMP compliance status and performance of third‐party sites through quality metrics, KPIs, trend analysis and periodic risk reassessments
Ensures appropriate management and QA oversight of deviations, non‐conformities, OOS/OOT, complaints and quality events related to outsourced activities
Ensures timely investigation, documentation, approval and follow‐up of third‐party‐related CAPAs, including verification of their effectiveness
Manages and approves quality‐related change controls impacting third‐party activities, including assessment of GMP and regulatory impact and oversight of implementation
Acts as the Quality reference for technology transfer projects involving third‐party manufacturing or testing sites, ensuring adequate QA oversight throughout all transfer phases
Acts as the Quality reference for process validation and analytical validation activities performed at third‐party sites, coordinating with Quality Control and other relevant functions as applicable
Applies technical process expertise to Quality oversight of third‐party activities, critically assessing process design, execution, validation approaches, and ongoing performance to ensure robust process control, product quality, and regulatory compliance
Acts as the Quality single point of contact for the evaluation of quality-related dossiers in the context of acquisitions and divestments, providing technically competent QA input on manufacturing processes, control strategies, validation status, and product/process lifecycle maturity to support informed due diligence and decision-making.
Supports the QA unit ensuring that the Manufacturing Authorisation Holder (MAH) obligations related to serialization and anti‐counterfeiting requirements are adequately fulfilled for products manufactured at third‐party sites, including data oversight and documentation availability
Provides QA support during regulatory inspections, certification audits and customer audits involving third‐party activities
Ensures that quality documentation related to outsourced activities is appropriately generated, managed, archived and readily available
Contributes to quality risk assessments linked to regulatory updates impacting outsourced activities (e.g. nitrosamines, elemental impurities, evolving GMP expectations)
Ensures the collection, consolidation and timely availability of third‐party quality data for Quality Management Review
Ensures the compliance to the legal, deontological, and corporate rules governing the activities under their competence;
Ensures compliance with laws and regulations in accordance with the provisions of the internal control model, D. Lgs. 231/01 and codes of conduct within the area of responsibility.
Qualifications:
Bachelor's/Master's Degree in Biology, Pharmacy, Chemistry or related scientific field;
8-10 years of experience in Quality, Manufacturing or Development areas in the Pharmaceutical/Life-science sector. xrdztoy
Required Skills:
Fluent English;
Technical expertise on manufacturing processes
Knowledge of the main productivity and collaboration tools (Google Workspace, MS Office);
Knowledge of national and international pharmaceutical and GxP regulations;
Proven ability to work autonomously and collaboratively within multidisciplinary teams
Knowledge of the Pharmaceutical sector.