Quality Data Engineer - Homebased

SUMMARY

The key purpose of the QA Quality Data Engineer within the QA team is to continually meet all quality assurance requirements providing exemplary quality engineering support with a focus on data. 

RESPONSIBILITIES

• Evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated.
• Provide direct support to Quality personnel regarding operation of Quality Assurance function. Provide support to other departmental activities as directed.
• Experienced in use of statistical and other quality tools for investigation processes, Risk Management and Root Cause Analysis.
• Internal Audit: Understands and has the ability to apply and audit the requirements of ISO 13485
• GMP/GDocP- Deliver trainings as desired to company employees.
• Change Control: Originate, review, and approve internal operating procedures and specifications through the Document Change process.
• Support NCR and CAPA: Corrective/Preventive actions and product non-conformance control including: capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analysing the data for the reasons of Quality Improvement and reporting. Conduct, Lead & Support CAPA projects and ensure effective solutions of same.
• Support Product Complaints: Support Product Surveillance through review and ownership of data/trend evaluations and investigations associated with product and patient complaints, analysing the data for the reasons of Quality Improvement and reporting.
• Take ownership and ensure Quality Dashboard statistics are updated on time to ensure Quality KPI’s and targets are met
• Adhere to Quality Management System (QMS) requirements in line with the company’s Good Manufacturing Practice (GMP) as per ISO13485 & FDA21 CFR Part 820.
• Ensure that process & timeline requirements for Corrective & Preventive Actions (CAPA) are met in accordance with the company Standard Operating Procedures (SOP’s) and in support of the company’ Global Objectives for CAPA.

As a QA Quality Engineer you will be accountable in:

• Influencing and leading - Develop a network of internal resources to facilitate completion of tasks. Individual influence is typically exerted at the peer level.
• Planning and organizing: Complete daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
• Driving decision making and making an impact: Exercise authority within pre‐established limits and approval. Failure to achieve results can normally be overcome without serious effect on schedules and programs.

The ideal QA Quality Engineer will:

• Have worked ideally within a medical device, pharma, aerospace, automotive, health care or similar highly regulated business.
• Have experience with CAPA's, Quality, Root Cause analysis, NCR's, Change Control, Engineering, Quality Assurance, Risk Management and Statistical/Quality tools.
• Hold a BSc or MSc or HNC / HND (or equivalent) in an Engineering or related discipline - mechanical or biomedical ideally
• Have time served experience in a similar Quality Assurance role.

DURATION

Contract 6-12months

SALARY

Attractive hourly pay rate

LOCATION

Homebased anywhere UK

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

TO APPLY

Please click ‘apply’ or contact Sam Chapple (Recruitment Team Lead) at Planet Pharma for more information:

E: schapple@planet-pharma.co.uk

T: +44(0)203 868 8607

Linkedin: https://www.linkedin.com/in/sam-chapple-42b459131/