Lssa Quality Assurance Manager (Hybrid)

The Opportunity:

The Quality Assurance Manager L.S.S.A will be responsible for all vaccines quality-related tasks in Argentina and for laboratory management.

The role will implement and maintain quality requirements of the Local Regulatory Authority and provide technical support and expertise in Quality processes.

The Quality Assurance Manager L.S.S.A is responsible for assessment all quality data for batch release and for proposing a release disposition to the Technical Director for approval.

The Role:

LSSA Quality Management System

• Maintains the LSSA Quality Management System, including:

• quality SOPs for Argentina in the Global Quality System according to what is required by the Local Health Authority (ANMAT)

• quality change control, quality deviations and CAPAs.

• Ensures all required policies and procedures are available in local language

• Provides support in quality, financial, Local Health Authority or other audits, as appropriate.

• Coordinates and reconciles product complaints with manufacturing sites and global complaints system manager.

• Coordinates with Local Technical Direction and Global QA.

• Participates in Health Authority inspections

LSSA Batch Release

• Manages batch release process and completes all batch release tasks relating to product supply to Argentina, including:

• Supporting and collaborating with the Technical Director on all documentation required for the release of the product prior approval of the Local Health Authority

• Assessment all quality data for batch release and for proposing a release disposition to the Technical Director for approval.

• Generating and signing Certificates of Analysis for local and imported products.

• Managing the local batch release in communication to ANMAT and using 3PL inventory management system

CMO Oversight

• Liaises with local CMO for campaign readiness, deviation and change management and local QA representative for Seqirus.

• Ensures QAG is in place with CMOs for products to be distributed in Argentina and is in accordance with ANMAT requirements. Ensures compliance with the QAGs.

• Co-ordinates with third-party (Warehouse, Distributor and CMO) for quality processes.

Distribution Oversight

• Leads with the Distributor and the Warehouse according to the Quality Agreement.

• Collaborates in the process of shipment and receiving imported and local products in the Distributor's warehouse.

• Verifies the results of dataloggers reading.

• Initiates / investigates any temperature, in-transit or damage related deviations.

• Coordinates of the annual product destruction with supplier, whether they are expired, broken in warehouse, etc.

Product Serialization Management

• Manages of the National Traceability System (SNT) and Traceability System of the 3PL distributor and Verifarma as appropriate.

• Registers and modifies the codes by completing the information within the GS1 platform.

• Obtains the identification barcode numbers of the products on the GS1 platform.

LSSA Laboratory Management

• Maintains the L.S.S.A. laboratory based on the Technical Director’s instructions for inspections.

Skills & Experience Required:

• Must be fluent with English and Spanish language, both written and spoken

• Degree in life science is preferred

• 3-5 years of experience in a GMP/GDP role, preferably Quality Assurance

• Technical Knowledge of Quality Systems, SAP management.

• Experience in:

• QA (Quality Assurance) in the pharmaceutical industry, preferably in manufacturer, importer and distributor of national and / or international pharmaceutical products.

• Drafting SOPs (Procedures), Instructions and records in certified management systems.

• Management of CAPAs (Corrective and preventive actions) and respective follow-up.

• Knowledge of Risk analysis and audits of applicable health legal standards.

• Knowledge in RA (Regulatory Affairs) for registration of medical products in ANMAT, FDA and CE (National Administration of Drugs, Food and Medical Technology, Food Drug Administration, European Community, respectively).

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