QA Reviewer

2 weeks ago

United Kingdom invoX Pharma Limited Full time

QA Reviewer

Department: Quality

Employment Type: Permanent - Full Time

Location: invoX Belgium N.V.

Reporting To: Iain Breakwell

Description

invoX Belgium NV - Respiratory Innovation Centre is focused on the development of pharmaceutical products with superior delivery to the lung using the differentiated technology in our next generation Soft Mist Inhalation (SMI) device. Our proprietary, propellant-free, purely mechanical device delivers medication to the lungs more effectively than other types of inhalers and is poised to change the treatment paradigm in large markets including asthma and COPD.

To help continue our growth and success, we are looking for a QA Reviewer to join our Quality team in Diepenbeek (Belgium), reporting to the Head of Quality.

You will have responsibility for QA review of documentation supporting formulation, analytics and device development and manufacturing activities related to SMI, to ensure adherence to applicable regulatory GxP and Medical Device guidance.

As a key member of the development team, you’ll work within a complex matrix environment with multiple stakeholders and on cross-functional teams to advise on drug and device development processes, quality requirements and global quality standards. Supporting technical R&D colleagues you’ll develop approaches to enable compliant development project delivery.

At invoX Belgium NV , development is achieved through an outsourcing model, so you’ll work with key development and manufacturing partners, coming to understand in detail about their documentation and processes. Additionally, you’ll be expected to travel to many of these key development partners from time to time, reviewing on-site where required.

Key Responsibilities

Document Review:

  • QA review of Invox Belgium project documents and records as necessary (including Design Control, Risk Management, Design Review).
  • QA review of vendor project documents and records as necessary (including protocols, reports, methods, validation and batch records).
  • Quality oversight of vendor data investigations (Out of Specification (OOS) and Deviation management).
  • A Quality function signatory on internal/ external project documents.


Vendor Compliance Monitoring:

  • Preparation of Quality materials for Project team meetings.
  • Maintenance, compilation, and analysis of Vendor Quality metrics.

Supporting work in the following area:

  • Maintenance of company certifications (ISO 13485).
  • Continuous Improvement (CI) of the documents and systems of the QMS.
  • Preparation and reporting of external audits.
  • Establish Pre-Approval Inspection (PAI) readiness at strategic commercial partners.
Skills, Knowledge and Expertise
  • Bachelor or higher degree in science or engineering or equivalent experience.
  • Good experience in a Quality role in pharma.
  • Good knowledge of Drug Product development and GMP is essential.
  • Good knowledge of ISO 13485 or USFDA medical device guidance is desirable.
  • Experience or interest in respiratory diseases.
  • Experience of working effectively in a complex and matrix environment with multiple stakeholders and on cross-functional teams.
  • Pro-active, hands-on, love to solve problems.
  • Fluent in English, both written and spoken.
  • Strong communication skills.
  • Keen to work in an international environment and willing to occasionally travel to vendors.
Why work for invoX?

We get things done, we keep things simple and we are driven by the science. We are ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations and socialising, which make invoX a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.

For this position candidates must be eligible to live and work in the EU #J-18808-Ljbffr

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