For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
We are currently looking for a freelance GMP project manager to help us support a key life science client based out of Ireland. This role offers the successful candidate the chance to work on a 6 month, full time project (40-45 hours per week) ideally starting in March/April. The successful applicant must be prepared to work onsite in Ireland throughout the duration of the contract and bring demonstrated experience working in GMP settings as a Project Lead/Manager.
Responsibilities will include:
Assist in developing project metrics to ensure a consistent implementation of works from concept through to handover and closeout.
Responsible for oversight and of site and global project execution resources.
Document and build the necessary site project procedural standards and controls to govern Project execution.
Ensure that project scopes are executed in a manner that is compliant with program milestones, Quality Safety standards, and budget plans.
Provide support to clients on quality issues such as OOS results, deviations and non-conformances.
Review RA/RAMS/method statements.
Provides Quality oversight of operations and data review for accuracy, completeness, and conformance to current Good Manufacturing Practices (cGMP) and company quality standards.
Qualifications
Qualified candidates will possess a Bachelor’s degree in science or engineering discipline
At least 7 years or more experience working in the life-science industry
Must have proven experience working as a Project Manager
Demonstrated experience in organizing and leading engineering support of GMP manufacturing operations.
Successful management of project portfolio within an operational GMP facility.
General knowledge of quality system elements and cGMP regulations.
Fluency in English
Can work onsite in Ireland 5 days per week
Can offer 1.0 FTE (40-45 hours per week)
Can commence a new project in March/April
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ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More
