Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Senior Quality Assurance Technician who shares our vision of providing clinical research excellence.
Joining Pivotal as a Senior Quality Assurance Technician means that you’ll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion into working in an environment designed to help you gain experience in a wide variety of therapeutic areas.
Why Pivotal
We are passionate and fully committed to medical science while using technology, to make a positive impact. We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as an untold international experience that will help you grow and will accompany all your life. We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives, being able to create a place where everyone feels like they belong.
Your responsibilities will include:
- Supports the Senior Manager, Quality Assurance and Compliance (Sr. Manager, QA&C) in Quality Assurance activities, assuring compliance with ICH/GCP standards and national/international regulations, both in processes and projects handled by Pivotal
- Supports Sr. Manager, QA&C in the maintenance of Quality Assurance system
- Supports Sr. Manager, QA&C in ensuring GCP compliance, assisting in promoting quality principles across the company, providing GCP advice to all staff involved in clinical study activities and providing input into process improvement initiatives across the company
- Organizes and participates in contracted audits as required (investigator sites, trial master files, database, ICFs, etc.)
- Supports Sr. Manager, QA&C in tracking and follow up of actions until close-out. Raise significant issues of non-compliance Sr. Manager, QA&C
- Supports the Sr. Manager, QA&C in preparing sponsor audits and inspections
- Supports Sr. Manager, QA&C in keeping updated the Quality Manual. Keep tracking of Pivotal Quality Manual documents. Review, update and implement Quality Manual documents as necessary
- Assists in providing internal training as required
- Provide oversight of computerized systems validation activities to ensure compliance with GxP and data integrity requirements
- Supports Sr. Manager, QA&C in tracking SOP deviations and quality issues. Follow up corrective and preventive actions
- Provides Quality Assurance support to company departments in all GCP activities as required
Requirements:
- Life science University Degree
- Previous experience in clinical trials in CRO/Pharmaceutical company: at least 3 years previous experience in Quality Assurance department, and/or a minimum of 5 years’ experience supervising clinical trials projects processes and procedures as LCRA or Project Manager
- Experience in international projects is highly recommended
- Experience in oversight of computerized systems validation (CSV) in GxP environments is a plus
- Ability to work effectively with clients and across internal departments
Skills:
- Thorough understanding of ICH E6 GCP, applicable national/international regulations, and EMA/FDA requirements
- Experience in auditing and preparing inspections is desired
- Flexibility and ability to investigate and analyze information, to draw conclusions and provide recommendations
- Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
- Ability to work autonomously
- Ability to work in a structured and organised manner
- Strong written and verbal communication skills, attention to detail and ability to work in a fast-paced environment
- Fluency in English
- Good knowledge of Office (Word, Excel and PowerPoint)
- Willingness to travel occasionally
What you can expect:
Resources that promote your career growth
- Leaders that support flexible work schedules
- Training to help you build your therapeutic knowledge
- Dynamic work environments that expose you to new experiences
Commitment to Equal Opportunity
At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.
