Senior Quality Specialist

2 weeks ago

United Kingdom ProPharma Group Full time

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.

Position overview

The Quality Specialist position supports the delivery of Medical Information and Pharmacovigilance services, to assure ongoing compliance with quality and industry regulatory requirements. The Quality Specialist performs improvement activities through continuous monitoring and evaluation of the quality system to ensure ongoing maintenance.

Essential Functions

Retrospectively evaluates telephone skills and case reports to ensure compliance standards are met and maintained.

Generate and prepare reports to communicate outcomes of quality activities.

Analyze and investigate, Deviations and Quality Events to identify areas for improvement in the quality system.

Review, approve, and communicate root cause and corrective action to stakeholders.

Develop, recommend, and monitor corrective and preventive actions.

Collection, management, and analysis of data related to CAPAs, Deviations and quality KPIs.

Record, track, and trend audit findings and response times.

Support the Quality Manager during external client audits or regulatory inspections by creating reports, gathering documents, and supplying requested data.

Perform effectiveness checks on Deviations and Quality Events to determine efficacy of CAPAs.

In conjunction with the Quality Manager, conducts routine Pharmacovigilance audits.

Supports and facilitates eQMS activities (i.e. Document Management, QA review and approvals, Change Control assessments, etc.)

Other duties as needed

Skills required

University/Bachelor’s degree and/or or appropriate relevant work experience

Minimum 3-5 years’ experience working in a Quality Assurance role

Exposure to Deviation’s; CAPAs; supporting or conducting audits would be preferred

Strong stakeholder management skills are a must

Happy to work remotely but some travel to ProPharma sites maybe required when critical

Thorough, dedicated and detail orientated

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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Tips to Avoid Recruitment Fraud

ProPharma will never ask you for any bank account information, financial information, or another form of payment to be considered for a role. Additionally, the ProPharma talent acquisition team will only use their work email addresses ( domain@propharmagroup.com ). If you receive recruiting communications from anyone with a yahoo.com, gmail.com, live.com, propharmagroupjobs.com, or any other email account, it’s likely a fraud.

Current Colleagues

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