Validation & Qualification Scientist
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
Quotient Sciences have an exciting career opportunity available for a Validation and Qualification Scientist based at the site in Reading.
In his role you will be a key part of the team responsible for monitoring equipment/facility and Qualification/validation and calibration/maintenance of all GMP equipment.
Other main tasks and responsibilities include:
- Lead validation/qualification projects and complete all associated documentation in line with regulatory expectations
- Manage, coordinate and guide the execution of the site validation master plan
- Provide the relevant support for regulatory audits, submissions and other auditor requests
- Develop and write commissioning, qualification and validation documents following established standards and templates.
- Execute test protocols
- Ensure that equipment/facilities are managed in conjunction with all regulatory requirements such as health & safety, cGMP, construction, environmental, etc.
- Ensure Data Integrity compliance is maintained in the qualification/validation of equipment and systems
- Perform and conduct P&ID walk-downs and verification of system drawings
- Ensure the qualifiation/validation status of equipment and systems are in compliance with cGMPs at all times.
- Manage validation documentation, commissioning test scripts, qualification validation protocols, summary reports and risk assessments
- Review design deliverables from engineering including drawings, datasheets, specifications and engineering lists
- Maintain validation documentation through the equipment lifecycle
- Provide evidence of both internal and external regulatory compliance
- Troubleshoot in the event of abnormal testing results
- Train staff members on the use of equipment/systems and facilities
- Ensure accurate records of all qualification/validation activities
- Updating SOP’s in line with periodic reviews and assisting in the preparation of SOP’s for new equipment.
- To assist with external contractors to enable calibration and maintenance activities to be performed and completed in-line with the schedule.
- Support site Data Integrity compliance
- Support QA in implementing & validating automatic data acquisition systems in GMP equipment and systems
The successful candidate will be educated to a minimum A level and having minimum 5 years Validation/qualification experience in a regulated environment. Experience in Pharmaceutical industry will be preferable. Have excellent written and verbal communication skills and be proficient in Microsoft Office – Word, Excel, PowerPoint etc.
Applicants must have the right to work in the UK upon being offered employment.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.