Job Description

Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the peopleWith Heart^®

Come and join our team at Parexel's Early Phase Clinical Unit in Harrow as a Senior Specialist in Pharmaceutical Services based at Northwick Park Hospital. You must have post qualification experience within the Pharmaceutical Industry, CRO, Phase 1 Unit, Hospital Pharmacy, or the Pharmaceutical Industry, working within Clinical Trial Packaging/ Manufacture.

As a Senior Pharmaceutical Services Specialist, you will assist in the set-up and conduct of Phase I studies within Pharmaceutical Services area in accordance with Good Manufacture Practice (GMP), Good Clinical Practice (GCP) and following local regulatory requirements and relevant Standard Operating Procedures (SOP's). When required you will assist and participate in the assembly /dispensing of Investigational Medicinal Product (IMP) in accordance with written instruction and in compliance with Good Manufacturing Practice (GMP).

Key Accountabilities:

Maintain drug accountability records in accordance with agreed protocols and the principles of International Conference on Harmonization Good Clinical Practice and Good Manufacturing Practice (Assembly (Manufacture, Packaging and Dispensing) of drugs in accordance with written instruction and in compliance with GMP

To set-up and manage assigned study from Pharmacy perspectives and ensure smooth delivery of study drug for clinical execution

Act as departmental study lead and set-up study activities

Check (or prepare if required) batch documentation relating to subject dose assembly, packaging, labeling and dispensing of IMP

If required, participate in the assembly or dispensing of IMP and study related drug following approved preparation / dispensing instruction

Implement PQS and tasks assigned and participate in the review of SOP or working practice.

Responsible for routine housekeeping

Assist with study audit as and when required

Assist and support Production Manager and deputises during absence

Training Pharmaceutical Service Specialist

Qualifications

Skills:

Must be a good communication, team player and well organised

Adaptability and flexibility

Excellent interpersonal, verbal and written communication skills

Client focused approach to work

A flexible attitude with respect to work assignments and new learning

Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

Willingness to work in a matrix environment and to value the importance of teamwork

Knowledge and Experience:

A wealth of post qualification experience within the Pharmaceutical Industry, CRO, Phase 1 Unit or Hospital Pharmacy working within Quality Assurance, Clinical Trial Packaging/ Manufacture

Experience with handling, managing and dispensing Clinical Trial Supplies

Experience with aseptic reconstitution /manufacturing activity

Experience with Clinical Trial Supplies (Manufacture, Packaging and Distribution)

Experience with batch documentation creation and review for Manufacturing, Packaging and Distribution of IMPs

Experience with EU QP certification and release of IMP

GMP and/ GCP auditing experience

Education:

Degree in Pharmacy/ Pharmaceutical Science/ or other life science

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.