Job Description

As a Pharmaceutical Services Specialist, you will assist in the conduct of Phase I studies within Pharmaceutical Services area in accordance with ICH Good Clinical Practice (GCP) and following local regulatory requirements and relevant Standard Operating Procedures (SOP's). 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.

Create and review master and production worksheets and labels for assembly activities.

Ensure controlled storage of all drugs (including controlled drugs, licensed drugs and unlicensed drugs) and materials sourced or supplied by sponsors for use in clinical trial studies.

Ensure PS facilities (Assembly and storage areas) are maintained in compliance with regulatory requirements

Maintain equipment list and ensure calibration and/ PPM is performed

Assist with investigation of quality incidents and deviations and ensuring corrective actions are completed.

Assist with audits (internal/ external) GMP).

Qualifications

Skills

Great communication skills.

Good attention to detail.

Enjoy working in a team.

Adaptability.

Education

Degree in Pharmacy, Pharmaceutical Science, Biology, Chemistry or life science.

Minimum Work Experience

Experience within the Pharmaceutical Industry, CRO, Phase 1 Unit or Hospital Pharmacy.

Experience with Clinical Trial Supplies (Manufacture and Packaging)

Experience with batch assembly/ manufacturing of IMP/NIMP.

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.