Offer summary

Qualifications:

Experience in a quality role within a highly regulated industry., Familiarity with Electronic Management Systems and handling deviations and CAPAs., Interest in change management and data analysis., Working knowledge of Salesforce..

Key responsabilities:

Generate and prepare reports on quality activities and inspections.

Analyze deviations and quality events to identify improvement areas.

Review and communicate root causes and corrective actions to stakeholders.

Support the Quality Manager with external client reports and eQMS activities.

Job description

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.

ProPharma are looking for a professional experienced in quality to join our business; this is a remote role across UK/CEE joining a small friendly team. The ideal candidate will be a professional currently working in a quality role within a highly regulated industry.

Duties include:

Generate and prepare reports to communicate the outcomes of quality activities
Analyze and investigate deviation and quality events to identify areas for improvement in the quality system
Review, approve and communicate root cause and corrective action to stakeholders
Ensures data integrity and accuracy
Prepares reports on the results of quality inspections
Collection, management and analysis of data related to CAPAs, deviations and quality KPI's
Evaluates outcomes of quality inspections and proposes corrective measure
Support the Quality Manager during external client reports
Perform effectiveness checks on deviations and quality events to determine efficiency of CAPA's
Supports and facilitates eQMS activities (document management, QA review and approvals, change control assessments etc)

Ideal candidate requirement:

Electronic Management Systems experience
Deviation and CAPA handling experience
An interest in change management and data analysis
Working knowledge with salesforce

#LI-LH1

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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