When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
As a Pharmaceutical Services Specialist, you will assist in the conduct of Phase I studies within the Pharmaceutical Services area in accordance with ICH Good Clinical Practice (GCP) and following local regulatory requirements and relevant Standard Operating Procedures (SOP’s). This is a 12 month fixed term contract.
You will participate in the assembly /dispensing of Investigational Medicinal Product (IMP) in accordance with written instruction and in compliance with Good Manufacturing Practice (GMP).
You will also manage assigned studies and are responsible for Pharmacy set up and delivery from start to end
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
Prepare production worksheets and labels for assembly activities
Participate in IMP assembly activity
Responsible for assigned housekeeping tasks
Responsible for Pharmacy set up and delivery for assigned studies
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
Assist with investigation of quality incidents and deviations and ensuring corrective actions are completed.
Assist with audits (internal/ external) GMP
Knowledge, Skills & Experience
Preferably experience of working within the pharmaceutical industry, a Clinical Research Organization (CRO), Phase 1 clinical trial unit, or a hospital pharmacy setting.
Experience with Clinical Trial Supplies (Manufacture and Packaging)
Experience with batch assembly/ manufacturing of IMP/NIMP
Injection/infusion preparation experience and aseptic skills advantageous
Great communication skills
Must have good attention to detail
Enjoy working in a team
Adaptability
Education
Degree in Pharmacy, Pharmaceutical Science, Biology, Chemistry, or life science
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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