Senior Computer Systems Validation Consultant

hace 4 meses

Barcelona, España Rephine A tiempo completo

**Who we are**:
Our clients refer to us as the Gold Standard in Life Sciences product quality. We are global experts in quality assurance & GxP compliance across Pharmaceutical, Biotech & Medical device manufacturing supply chains.

Rephine Barcelona is part of the Rephine Group, with offices at Spain (Barcelona), the UK (Stevenage), China (Shanghai) and India.
- Are you a Pharmaceutical and Life Sciences lover? Are you oriented to work on a team? Are you passionate about learning? Do you want to make a difference by managing Multi-Projects Consulting? Are you ready to work in Global multisite company?_

We are looking for a **Computer Systems Validation Senior Consultant t**o join our Barcelona team.

**Your Challenge**:

- Our team of highly experienced, top-level consultants carry out key projects for companies around the world in the areas of:_
- GxP readiness. Assessing and targeting improvements while ensuring there are no gaps in quality or compliance across all phases of the product development and manufacturing lifecycle.
- Design Review of new facilities, commissioning and qualification of equipment and utilities are also key aspects of this service.
- Digital transformation. Assisting on how to redesign and optimize manufacturing quality processes to take advantage of the latest technology (cloud-based solutions, IoT or AI/machine learning), validate those systems and ensure data integrity.
- Medical Devices. Latest regulatory framework and manufacturing requirements specific to smart/digital devices as well as health tracking apps.
- Quality management System (QMS). Advisory service helping our customers to achieve a systematic approach to Quality design and maintenance, and optimized business processes. We also deploy the TrackWise Digital Quality Management Software.

**Your main responsibilities**:

- Reporting directly to CSV Project Manager:

- Collaboration on GxP compliance projects, especially in Computerized Systems Validation projects
- Active role in the delivery of Validation of Computerized Systems including customer service, writing of validation documentation (Validation Plan, Risk Assessment, Requirements, Protocols, tests scripts, etc), test execution and reporting.
- Comply with the deadlines agreed with customers (iex delivery of documentation, test execution, etc)
- Keep clients and Project Manager up to date with the project's evolution, incidents, and actions.

**Your team**:
If there is something that characterizes Rephine team, it is our absolute commitment to our customers and it is precisely that which keeps us in constant growth. The involvement, experience, and expertise of our consultants is our greatest asset.

Join our young enthusiastic consultants, share **our values & goals, and grow with us. You can be part of the success of our projects.**

**This Job is for you IF**:

- Bachelor's degree in chemistry or engineering.
- Experience working in pharmaceutical environment and knowledge of the pharmaceutical and chemical business, manufacturing, and quality processes (GxP compliance, validation, and quality systems management, GMP Annex 11, 21CFR part 11).
- Interest or expertise in computerized systems, automation, and programming.
- Strong teamwork skills.
- Be able to carry out several projects simultaneously.
- Availability to travel. Customers are mostly located within Spain, but also at European countries, China or other.
- Excellent communication, customer-faced skills, understanding customers’ requirements and translating them into technical solutions, and explaining technical concepts to non-technical audiences.
- Fluent in both Spanish and English. Other languages are highly valuable.
- Experience in Agile methodologies is a plus.
- Experience in CSV is highly valuable, especially in ERP, EDMS; EQMS, systems.

**Your career at Rephine**:
We are growing and constantly evolving, looking for professionals who want to stay and develop their career with us.

**We offer**:

- Benefits: Competitive salary according to experience, additional extra-legal vacation days, and other competitive benefits.
- Teamwork: highly qualified staff with numerous years of experience, always available to help.
- Flexibility: Hybrid mode, autonomy, reduced workday each Friday, flexible hours.
- Global Company: Growing global company and multicultural team.
- Learning program: Training and development program
- Continuous training and English and Chinese lessons
- Occasionally teambuilding, social events and Rephiesta.#
- Excellent culture and work environment. Young and enthusiastic team of consultants.

**Why Rephine?**:
During the 20+ years, we have been able to work closely with many of the largest companies in Life Sciences. We have joined their teams, worked with them at their facilities and advised them on how to improve their manufacturing quality processes. We are growing and in constant evolution, looking for professionals who want to stay and develop with us.

Visit our

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