Auftragsdetails

Quality Specialist - propharma group

Datum der Veröffentlichung: Jan 23, 2023
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Auftragsdetails

  • Ort:
    London, London, United Kingdom
  • Gesellschaft:
  • Typ:
    Full Time/Permanent
  • Shift:
    First Shift (Day)
  • Karrierelevel:
    Experienced Professional
  • Positionen:
    4
  • Erfahrung:
    2 Year
  • Geschlecht:
    Keine Präferenz
  • Grad:
    Bachelors
  • Vorher bewerben:
    Nov 30, 2023

Job Summary

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.

 

 

The Quality Specialist position supports the delivery of Regulatory Sciences 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. This position may also support regional and global activities as required.

Detailed Description

Responsibilities

  • Quality contact for Regulatory Sciences. First point of contact for Regulatory staff with regards to support and guidance in following ProPharma´s QMS procedures.
  • Process Deviations and Quality events through eQMS to conclusion with support from Regulatory SME, as required.
  • Review, approve, and communicate root cause and corrective action to stakeholders.
  • Develop, recommend, and monitor corrective and preventive actions. Tracks documentation, as necessary.
  • Collection, management, and analysis of data related to CAPAs, Deviations and quality KPIs.
  • Support during internal/external client audits or regulatory inspections.
  • Support and facilitate eQMS activities (i.e. Document Management, SOPs and WIs, QA review and approvals, Change Control assessments, etc.)
  • Act as the main point of contact for client questionnaires relating to
  • Quality. Provide responses to Quality questions, getting appropriate Subject Matter Expert input where required. Communication with clients, including sending of completed questionnaires.
  • Act as Quality support for Vendor Management, including:
  • Qualify new vendors        
  • Vendor Questionnaires    
  • Re-qualify existing vendors
  • Identify new vendors (together with business unit)
  • Administration for Vendor Contracts
  • Maintain vendor tracking sheet
  • Other duties as needed.

Experience required

  • Minimum 2 years’ experience working in a Quality Assurance role
  • Deviation and CAPA handling experience
  •  Quality Certification is an advantage

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.

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Company Overview

Berlin, Berlin, Germany

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

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