Position : Quality Assurance System Manager
Experience : Minimum 10 years’ experience with solid knowledge in mainly QA, QC and GMP related activities.
What are we looking for?
QA Systems Manager ensures compliance with new and existing quality standards and regulations, implementing quality management actions, and contributing to the development and implementation of company policies and procedures. QA Systems Manager provides quality support to projects from the planning phase to project completion.
Ready to be a #Challenger?
The challenge!
QA Systems Manager is responsible for :
Global Quality Management System
- Supporting activities, investigations, and risk analysis in terms of quality management system elements like deviation, CAPA, change control, incidences, audit etc.
Global Quality Standards
- Establish effective Quality Systems by the development and execution of Global Quality Standards.
- Global Quality Standards Distribution, Deployment in all Sites, Training of users.
- Work closely with the site QA and Operations leadership to monitor status of compliance with Global Quality Standards and to ensure appropriate information flow and transparency.
- The translation of the strategies into effective and robust Global Quality Standards.
- Monitoring of Current Regulation, Guidelines and Standards and update the GQS system accordingly.
Training System
- Development and implementation of Corporate Quality Training Programs that support compliance objectives applicable to regulatory requirements, local and global processes.
- Training plans creation, follow up and execution.
- Yearly trainings follow ups.
Quality Performance Indicators (QPI)
- Supporting Quality QPI data collection and reporting global QPI according to the applicable procedures.
- Improvement of QPI according to the applicable industry standards and regulations.
Maintenance of Computerized Systems
- Support activities related with Quality software platforms such as TrackWise Digital, Labware LIMS, OpenText and OnBase document management.
- Supporting e-compliance management of the global computerized systems and developing procedures.
- Granting QA and Data Integrity Compliance in the Global System administration and change management, including, periodic system review and self-inspection / audit of the controls and user permissions established with the system. This should also consider preparation for and defending external audit and inspection.
- Follow up global validation documentation.
- Periodical review of global CS systems (Back up, restore, disaster recovery, periodical review for qualification).
- Creation of global SOPs for System configuration / administration and use.
- Configuration support of Static and Dynamic data for the modules.
- Participation in the accuracy verification of all data to be imported in the PROD environment.
- Participation in the execution of validation scripts for the system functionality.
- Participation in the training activities of key users at the Sites.
- Interaction with the local key users to capture key data to be migrated into the System.
- Global Quality Business Administrator in GxP system after implementation.
- Creating supplier oversight of Global Quality suppliers including quality agreement, audit and qualification.
- Contribution to supplier and corporate audit risk assessments.
Audit
- Provide support to the global quality audit program, to assure an effective program to evaluate and measure supplier compliance.
- Provide auditing support to the global quality audit program as a Lead Auditor in case needed.
Project Management
- Collaborating in the creation, management, and reporting of the global and site-specific project plans.
- Integrate, contribute, and / or lead cross-functional project teams as required. Support project schedules as required.
Soft Skill Requirements
- Integrating and collaborating with the rest of the team members for the successful achievement of the objectives.
- Foster a positive employee relations environment and a culture of continuous improvement and teamwork.
- Live the company values.
What do you need?
- Education : University Level in Chemistry, Pharmacy or other relevant Science / Engineering discipline, with significant training / exposure, healthcare or specific to Quality Assurance / Quality Control is an advantage.
- Languages : Fluent Spanish and English knowledge of other languages especially in Spanish will be an asset.
- Experience (years / area) : Minimum 10 years’ experience with solid knowledge in mainly QA, QC and GMP related activities.
- Specific Knowledge : Advanced knowledge of GMP requirements for products and processes, Quality Systems and Quality Best Practices. Adequate knowledge of current and upcoming legislation of International Markets.
- Travels : about 15% of the time, though this percentage may be increased.
- Personal skills : Autonomy and reliability, hands on hard worker, excellent communicator, ability to manage global expectations.
- Flexible start time from Monday to Friday (full-time 40 hours).
- Permanent contract.
- Attractive salary package.
Quality Assurance Manager
- Madrid, Community of Madrid, Spain
J-18808-Ljbffr
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