Job Description
Our client is a highly ambitious young pharmaceutical company, seeking a strong self starter experienced in managing project in a new environment. Project Manager will be responsible for the planning, procurement and execution of projects that have a defined scope, defined start, and a defined finish. Projects will mainly deal with non-clinical pharmaceutical research and with CMC (Chemistry, Manufacturing, and Controls). Project manager will be in full control of each project. The Project Manager ensures that research studies are executed with quality and efficiency, with on-time delivery, within budget, and meet company objectives.
Duties:
Responsible for making sure that research studies and CMC procedures are performed in compliance with quality standards (ICH/GMP/GLP, Global Regulations). Responsible for the development of the study design and associated systems and documents (for example: CDA, MSA, Study Protocol, Study Report).
Responsible for the vendor selection, management, and oversight of external vendors in compliance with company SOP and the applicable regulations. Tracks action items to ensure timely resolution. Responsible for regular updates to the cross-functional team and stakeholders on study status. Responsible for study budget creation and oversight of spend against approved budget.
Requirements:
Requires a Bachelor's Degree in scientific discipline ideally chemistry or chemical engineering plus six (6) years’ experience in a quality discipline and 2 years in Pharma related/research-related project management. Competent knowledge of current GMP chemistry manufacturing and pharmaceutical development processes. Knowledge of cGMP regulatory compliance standards and regulatory filings. Proven project management skills building and maintaining productive relationships with organizational partners such as manufacturing and quality. Excellent communication and teamwork skills. Understanding of validation of pharmaceutical facilities, equipment and process Proficient in Microsoft Outlook, Word, Excel, PowerPoint, Photoshop, Adobe Acrobat, and Project. Ability to manage, coordinate, format written reports and presentations for EMA/FDA submissions. For further information on this position please contact John
Phillips at The RFT Group on 01 2302400 / john.phillips@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie