CSV/QA Compliance Manager

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CSV QA Compliance/IT Manager

Glasgow area

3-6months with very high possibility of extensions

£50 - £70 per hour depending on experience

3 days per week with the possibility for further days, depending on the candidate

My client is a global provider of cardiovascular implants whom pride themselves on innovative products to improve patients' lives.

You will play a key role in developing their CSV Business Standard and bringing them up to a compliant standard (to allow CAPA closure) including understanding and adherence to their policies and procedures. This will be a demanding role so you must be able to cope under pressure.

You won't have direct reports, but will be helping lead the project from a QA/CSV perspective as a subject matter expert.

Day to day Duties:

* Audit existing CSV processes from QA and industry good practice perspective in medical devices manufacturing environment

* Define standards to ensure compliance with regulatory requirements for CSV and 21 CFR Part 11 compliance author and establish site-wide CSV strategy and policy across the company

* Establish scalable, risk based approach for prospective and remediation CSV using Quality Risk Management process and tools

* Document CSV processes and procedures

* Develop CSV templates and training resources

* Train, coach and mentor other employees in IT/Systems QA and CSV

* Oversee CSV program to ensure compliance with FDA and other regulatory requirements

* Lead and execute CSV lifecycle activities

* Author and review validation documentation for prospective and remediation CSV

* Embedding CSV into the standard process

* Work as part of a project team, reporting to a Project Manager

Skills Required

* Experience in IT/Systems QA or CSV leadership/management

* Ideally have a certification in Quality Systems (e.g. ISO, Lead Auditor)

* Experience of CSV in small to medium medical devices manufacturing

* Experience in managing CSV to establish regulatory compliance

* Systems awareness - small, stand-alone to site-wide networked systems (e.g. Excel spreadsheets, production systems, PLC, ERP, DMS, BMS)

* Experience with quality assurance standards such as ISO, QSR, GMP

* Experience in FDA inspections and audit strategy, cGMPs and an ability to interpret regulatory requirements

* Good Medical Devices background

* Experience mentoring and training others

The role is to start as soon as possible but they can wait a few weeks for the right person. Telephone interviews will be happening in the next few days.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales