QA Associate (Europe)
Consultant Irene Brasó
Date posted 3 de mayo de 2018Paseo de la Castellana 13, 4ª planta 28046, Madrid Robert Walters Spain
We are hiring QA Associate Technician for an internacional contract manufacturing company located in Barcelona city.
The purpose of the job is to provide support on routine quality assurance tasks related to the management and oversee of EU Contract Manufacturing, In-License and/or Service Providers.
Building and maintaining good working relationships with the Contract Manufacturing, In-license and/or Service Providers, and internal stakeholders providing support in the co-ordination of the contractor approval program.
The main functions and responsibilities are:
- Maintain log of all contractor's quality tools which impact to the company.
- Ensure logs, databases, and all product related files and Quality Assurance activities are maintained up to date, providing support to all Affiliates and Global Quality.
- Collect and file Batch Release Certificates and Certificates of Analysis for all products released by external contract manufacturers within EU.
- Support the compilation of annual Product Quality Review reports for the products manufactured within EU by external contractors.
- Perform trend reviews and compilations of metrics (KPIs) for Management Review. Compile and maintain contractor qualification reports.
- Handle change control requiests as assigned, initiating and routing internal change control requests for evaluation and/or approval, and monitornig progress of related action items.
- Process product complaints as assigned, recording complaint details and coordinating contractor investigation under line manager supervision.
- Log all quality investigations related to batch deviations, product disposition, validation activities, quality complaints, OOSs or other quality issues as required, liaising with itnernal subject matter experts and affiliate Responsible Person as applicable.
- Manage contractor documentation, ensuring compliance with cGMP and registration requirements. This includes all master batch records, process validation protocols and reports, analytical methods transfer, etc. received and or sent to the contractor.
- Co-ordination of documentation control activities, liaising with appropiate personnel to progress updates and approvals, with responsibility for filing of all complete quality system documents from or send to the contractor. Maintenance of document control system-paper and electronic.
- Provide support on European external contract manufacturing suppliers' audits, preparing for audits/assessments by researching background information (copmlaints, changes, etc.) including previous audits.
- Draft and progress Quality Technical Agreement for internal review and approval.
Relevant skills & experience:
- Scientific background (BSc in Pharmacy or equivalent)
- At least 2 years of hands-on Quality Assurance.
- Pan-EU experience in the pharmaceutical industry. Knowledge of European regulations on QA and regulatory affairns.
- Great command of English.
Please, do not hesitate to contact me or apply to the vacancy!