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Job Details

QMS Compliance Manager

Company: i-Pharm Consulting
Location: Hertfordshire
Reference: DAWRCL
Closing Date: 23 Jul 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

INTRODUCTION i-Pharm Consulting are working exclusively with a biopharmaceutical consultancy who require an experienced QA professional to join their team. This permanent opening will see you working collaboratively with other senior management members to develop and implement a robust quality management system. ...

Requirements:

INTRODUCTION

i-Pharm Consulting are working exclusively with a biopharmaceutical consultancy who require an experienced QA professional to join their team. This permanent opening will see you working collaboratively with other senior management members to develop and implement a robust quality management system.

JOB SUMMARY

* Specialised biopharmaceutical consultancy
* Established client base
* Rare opportunity to originate entire 9001 QMS
* Cohesive working environment
* Highly competitive remuneration

TITLE

* QMS Compliance Leader

LOCATION

* Hertfordshire, UK

RESPONSIBILITIES

* Hands on development of QMS in line with GxP guidelines
* Writing critical documentation (IMPD, IND, product development plans)
* Responsible for CTA, GMO and ethics submissions
* Managing the overall quality function for change controls, non-conformance, complaints and CAPAs
* Planning, conduct and follow-up of all audits and inspections
* Leading all GDPR-related activities for the business
* Training and development of staff in relation to QMS compliance
* Ensuring the business are kept updated with all related regulatory updates and required practices


REQUIREMENTS

* Relevant Life Sciences degree
* Experience in developing and maintaining biopharma/medical device QMS
* Broad GxP understanding (including IPHA and ABPI where applicable)
* Membership with recognised governing body (ISO, IRCA, CQA etc.)
* Experience of leading both internal and external audits
* Line management experience


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, Consultancies, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, Validation 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 / SOP / SAE / Quality Assurance / QA / QA specialist / QA Manager / Quality Assurance / QA Leader / Quality Manager / QC / Quality Control / Senior Manager / Senior Management / Pharmaceutical / Quality Engineer / QA Engineer / Site Audit / Internal Audit / External Audit / Solid Dose / 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 / Home-Based / Home Based / England / Wales / Scotland / Ireland / London / Birmingham / Liverpool / Manchester / Newcastle / Hull / Nottingham / Sheffield / Cambridge / Oxford / Southampton / Bristol / Cardiff / Coventry / Leeds / Sunderland / Luton / Stevenage / Welwyn Garden City / Uxbridge / Essex /

Apply for this job: QMS Compliance Manager

Contact Information:

Address:  Head Office
212 New King’s Road London
SW6 4NZ
England
Reasons to work for i-Pharm Consulting
Tel:  +44 (0) 20 3189 2299
Website:  Visit Our Web Site

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