CQA Specialist - 12 month fixed contract at Vontive

London, England, United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, PharmaceuticalsIndustries

Requirements

Proven experience in a Quality role working with the Ministry of Health (or other governmental health departments) within the pharmaceutical and/or medical device industry
Demonstrated experience successfully planning and conducting internal audits, as well as supporting audits for the Ministry of Health or other notified bodies
Outstanding knowledge of country specific (MHRA/HPRA) and EU regulations
Working expertise of Quality Management Systems (e.g. ISO9001, ISO13485)
Well organised with an eye for detail, excellent communication skills and ability to flourish working within an international and dynamic team

Responsibilities

Support the implementation and maintenance of the Quality Management System, completing Gap Analysis and risk assessments and ensuring that local systems comply with Vantive Corporate and Regulatory requirements
Process local documentation on TcU
Manage local field action implementation, including coordinating implementation and execution of field actions according to Vantive procedures; liaising with local stakeholders; completing customer communications and due diligence; managing Ministry of Health communication (MOH) communications; reconciliation activities and closure
Support complaint handling: responsible for initiation / completion of Medicinal Product Complaint Risk Assessments, notification of reportable Quality Defects to the HPRA and any HPRA correspondence relating to Quality defect
Support the correct local QA setting up of products in the enterprise management system (JDE)/3PL warehouses
System release of UK products/Re-certification of medicinal products received into IE from the UK including reviewing temperatures of shipments and assessing the impact of temperature excursions in the supply chain
Support supplier approval and maintenance of third-party products, including Supplier Corrective Action Requests including initiation and review of technical quality agreements
Re-verification of customer bona fides (IE only)
Participate in the internal and external audit program and ensure that any resulting corrective/preventive actions are completed with the agreed timescales
Support management of non-conformances including issue investigation and execution of corrective actions; support the Change Control process
Carry out additional Quality related tasks and assignments as required by the Department Manager

Skills

Key technologies and capabilities for this role

Good Distribution PracticeGood Manufacturing PracticeGMPcGDPQuality Management SystemGap AnalysisRisk AssessmentsField ActionsRegulatory ComplianceMedical Devices Directive

Questions & Answers

Common questions about this position

Is this position remote or home-based?

This is a home-based position within the UK.

What is the employment type and duration for this role?

This is a full-time, 12-month fixed-term contract position.

What are the main responsibilities of the CQA Specialist?

Responsibilities include supporting the Quality Management System with gap analysis and risk assessments, managing field actions, supporting complaint handling, system release of products, and participating in audits.

What is the company culture like at Vantive?

Vantive fosters a community of focused, courageous people who are driven to improve patients’ lives worldwide and don’t settle for the mediocre.

Who does this role report to?

The role reports to the CQA Manager for UKI.

Vontive

Provides investment property mortgage solutions

About Vontive

Vontive provides investment property mortgages using technology to simplify and speed up the loan process. Their main product is a "bolt-on" technology that allows retail brands to easily launch their own mortgage services without needing programming skills. This no-code solution can be set up in just a few weeks, making it quicker for brands to offer mortgages. Vontive stands out from competitors by acting as a bridge between real estate investors, lenders, and capital providers, charging fees for their services that reduce traditional risks and inefficiencies in real estate financing. The company's goal is to modernize the investment real estate market by making the mortgage process more efficient and transparent for both retail brands and financial institutions.

San Francisco, CaliforniaHeadquarters

2017Year Founded

$32.1MTotal Funding

DEBTCompany Stage

Financial Services, Real EstateIndustries

11-50Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Parental Leave

Short- and Long-term Disability Coverage

Life Insurance

Wellness Program

Risks

Increased competition from fintech companies could erode Vontive's market share.

Potential regulatory scrutiny may lead to higher compliance costs and challenges.

Economic downturns could impact demand for investment property mortgages.

Differentiation

Vontive offers a no-code, white-label mortgage solution for real estate investors.

The platform integrates financial institutions through a unique debt marketplace.

Founded by industry veterans, Vontive leverages decades of mortgage and financial expertise.

Upsides

Vontive ranked #10 on the 2022 Deloitte Technology Fast 500 with 9,154% growth.

The company has financed over $1.1 billion in residential properties since April 2022.

Vontive's B2C ecosystem reaches over 1.5 million real estate investors.

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