i-Pharm Consulting

QA Specialist

Location
Stevenage
Salary
Negotiable
Posted
10 Jan 2019
Closes
24 Jan 2019
Ref
DWQAS1
Contract Type
Permanent
INTRODUCTION

i-Pharm Consulting are partnered with a truly unique biotechnology development organisation with an outstanding reputation on the global market. They are looking to strengthen their Quality division with a QA Specialist to be based at their state-of-the art Hertfordshire facility.



JOB SUMMARY

- Opportunity to lead cutting edge QA projects within Cell Therapy
- Truly unique biotech company
- Groundbreaking therapies within Autoimmune and Oncology
- Elite industry leaders and cohesive working environment
- Excellent scope for professional development



TITLE

- QA Specialist



LOCATION

- Hertfordshire



RESPONSIBILITIES

- Involved with strategy for design and implementation of governance process for the Cell Therapy facility

- Ensure the QMS is maintained in diverse and robust fashion

- Participate in regulatory and client inspection (EMA, FDA)

- Providing support to the facility's overall compliance and acting as the SME for general quality matter

- Active participation in the internal auditing programme that includes CAPA implementation and related tracking processes



REQUIREMENTS

-Educated to B.Sc level in related life sciences subject

-Proven experience within a GMP ISO:9001 quality role, preferably within the field of biologics

- Excellent working knoweldge of FDA and EMA guidelines

- Strong communication skills in both internal and external environments



ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.



www.i-pharmconsulting.com



TO APPLY

If you would like to discuss this vacancy further, please call Senior Consultant Dominic Williams on +44 (0)20 3873 7066, or email dwilliams@i-pharmconsulting.com. If this role is not suitable, Dominic is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS

CAPA / Quality Systems / QMS / Audit / Auditor / GxP / GMP / GDP / SOP writing / QP / Qualified Person / IMP / SOP / SAE / Quality Assurance / QA / QA specialist / QA Manager / Quality Assurance / QA Leader / Biologics / Cell Therapy Quality Manager / QC / Quality Control / Senior Manager / Senior Management / Pharmaceutical / Quality Engineer / QA Engineer / Site Audit / Internal Audit / External Audit / Solid Dose / ATMP / Solid Dosage / ISO:9001 / GDPR / Submissions / ISO 9001 / ISO: 9001 / Good Manufacturing Practice / SOP / Good Distribution Practice / GMO / CMC / IMPD / IND / Root Cause Analysis / RCA / Hertfordshire / Stevenage / St Albans / London / Cambridge / Welwyn Garden City / Letchworth Garden City / Hitchin / Luton / Bedford / Bedfordshire / Hertford / Hatfield / Helem Hemptstead / Watford / Harlow / Enfield / Saffron Walden / Essex / Bletchley / Milton Keynes

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