Business Job Title:QP – Qualified Person
Job Profile Title:Qualified Person – Pharmaceutical Quality
Direct Report To:Senior Qualified Person
Group / Division:Clinical Trials – Fisher Clinical Services (FCS)
Location: Horsham, with 3 days a week onsite and 2 days a week from home/remote
Working Hours:Part-Time, 20 hours a week. Supporting Late Shift -working hours to take place Monday to Friday, between 4pm and 10pm
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of 24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Due to growth within the Quality team of our Fisher Clinical Services brand at Horsham, we have an opportunity for a Part-Time QPto join us and support our Late Shift Team.
In this role you willbe named on the UK MIA (IMP) license and will support a range of QP duties, which are mainly manufacturing related, such as releasing, troubleshooting, electronic batch recording (EBR), including input into the quality system, batch record review and sign off, and liaising with manufacturing to assess and solve problems.
You will be part of the QP team, sitting within the wider team of Quality for Horsham, which consists of circa 60 employees. The QP team supports QP certification activities, maintaining up-to-date awareness of current legislation and contributes to QP policies.
The role is based on site in Horsham, with 3 days onsite and flexibility for 2 days a week remote/home working.
What you do will include:
- Providing QP certification in compliance with regulatory requirements and if required, specific client technical agreements
- Providing QP GMP declarations
- Acting as a Quality Lead and a key contact point for Quality for major clients
- Providing information and training on the EU QP roles and responsibilities to FCS personnel both inside and outside of the UK
- Supporting teams within Business Development and Project Management at pre-contract stage to assess new contracts.
- Providing technical advice and support in the preparation of Technical Agreements
- Support client and competent authority audits/inspections with QP input
- Technical contribution to the operations of the site
How will you get here?
Experience, Qualifications & Abilities
- You must be an eligible Qualified Person (as per Article 49 of Directive 2001/83/EC) with the ability to be named on a UK MIA (IMP) license – weare open to someone who is newly qualified or more experienced.
- Able to work part-time and later hours as outlined.
- Training will take approx. 2 months and will need to be completed during standard working hours.
What’s in it for you:
- Competitive base salary
- Opportunities for career development and progression
- Remote and flexible working optionsonce training is completed
- Annual bonus
- Free on-site car parking
- Competitive contributory pension
- Private medical insurance
- Flexible benefits
Thermo Fisher Scientific Inc. is the world leader in serving science. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
With Thermo Fisher Scientific, it’s not just a career. It’s a chance to realise your best – professionally and personally.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.