CQA SpecialistReq # JR - 026749 Location Néo Irákleio, Attica, Greece Job Category Quality Control Date posted 08/31/2020
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The Country Quality Assurance (CQA) Specialist is responsible for:
- To ensure execution of following CQA processes in the country:
- Local Complaint Coordinator
- TcU Expert User (Documentation System)
- Field Corrective Actions coordinator (back-up) - Recall Process
- Hold coordinator
- JDE expert user (ERP system)
- Release and relabeling of products (back-up)
- Preparation and submission of monthly reports to MoH
- To ensure that processes and procedure related to mentioned activities are compliant to local regulations, to the Corporate Quality Manual and to the ISO 9001:2000 and 13845 requirements
- To be responsible for Documentation of QMS
Essential Duties and Responsibilities
Be the Local Complaint Coordinator for Product Quality Complaints (PQCs) and Medical Device Reports (MDRs).
- Following the applicable procedures on complaint handling process per Corporate, regional, and local procedures
- Collecting relevant product complaint information (Using call scripts when applicable)
- Coordinating sample shipment when applicable
- Entering the complaint into database
- Work closely with the Central Team of Product Surveillance EMEA
- Identifying potential therapeutic product adverse event information and understanding the requirements for notifying appropriate Pharmacovigilance Units
- submitting regulatory reports when applicable to Authority
- Accurately documenting the decisions and actions associated with the processing of the complaint
- Coordinating investigation activities and Authority requests with Central Team of Product Surveillance EMEA
- Processing of complaint in a timely manner
- Updating fields in TW (TrackWise) upon receipt of additional information
- Ensuring appropriate responses are provided to the customer where required
- Training local functions on product complaint processes and regulatory requirements
Reporting and managing authenticity labels from EOF to the relevant EOF database on daily consumption/reconciliation in the WH – communicate with EOF for ordering the labels needed each month.
Be the FCA back-up :
Prepare Batch Recall Report
Print letters and addresses
Concur in ensuring execution of FCAs according to the European and local Procedure
Concur in ensuring process and procedures are in place
Be the country JDE expert user :
Batch recall report
Hold – JDE coordinator
Ensure process and procedures are in place
Execute transactions for lot status changes (returns/releases/destroy of stocks in the system)
Concur in ensuring systems and procedures are in place and maintained for:
Returned goods management (back-up)
The control of the quarantine and other segregated areas for returns and products on hold
Controlling the receiving end of the on-status shipment process
Product traceability, tracking and accountability, as required.
Product reworking and re-labeling
Clinical trial products, if requested
Assure that systems are in place and maintained to train employees in quality system compliance (including new SOP’s).
Ensure training records are maintained
Give training on request or when required to other personnel (Warehouse/ Technical Service)
QMS & Documentation Concur in ensuring the execution at the country level of the Applicable Quality Manual.
This involves the monitoring of the performance of the quality system.
Concur in ensuring all relevant SOP's are in place to meet Corporate Quality Manual requirement and ISO 9001:2000/13845 standards
SOPs archives management
New SOPs preparation and issuance SOP’s distribution management
Obsoletion SOPs management
Preparation of the Quality Manual Preparation of documentation for management reviews
Additional knowledge or skills gained through a combination of academic study, job experience is required, e.g.:
- Ability to liase with the different functions involved, Customer Service, Regulatory Affairs, Pharmacovigilance, Business and Third Party Logistics Provider
- Excellent English
- Excellent knowledge of Microsoft Office and Outlook
- Knowledge of ERP as JDE will be considered as a plus.
- Language skills : Greek & English Excellent (spoken, written, read)
- Computer skills : MS Office – Excellent, particular IT knowledge preferred on ERP system e.g. JDE Edwards
- Technical skills:
- Tracking and understanding of applicable country regulations
- ISO 9001 /13845 knowledge
- Attention to details
Education and/or Experience
- University degree, preferably related to pharmacy or any other health science.
- 1-5 years of experience
Field of expertise: Quality Assurance
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.