Quality Manager (contract) - Paris

Lawrence Harvey


Job ID :

8202


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Other


Address 1 :

Western Europe,--Paris,Paris,


Key Skills :

Quality, manager, paris, france, french


Salary :

Negotiable


Date Posted :

09 Aug, 2017



Company Name :

Lawrence Harvey


Location1 :

Paris




Job Category :

Quality Assurance Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Job Summary

Responsible for site-specific aspects of the Quality Management System to ensure the company meets and maintains all applicable quality and regulatory compliance requirements.



Main duties and responsibilities

* Manage the requirements for quality and regulatory compliance for the manufacture, sale and global distribution of diagnostic products.
* Support for regulatory and customer audits.
* Managing the company's key supplier base from a quality perspective.
* Support and develop data for input into the site management reviews.
* Provide quality and regulatory support to development and OEM projects, including the generation review and approval of process validation documentation.
* Review and approval of technical, regulatory and QMS documentation.
* Assist in regulatory submissions for existing and new products.
* Support compliance of the company's Risk Files in accordance with ISO 14971.
* Assist where required in process and product compliance to assure GMP is maintained for IVD manufacture.
* Maintain the site complaint investigation and vigilance reporting processes, and co-ordinate site PMS activities.
* Site responsibility for the Q-Pulse system.
* Ensure Executive Team (through the HQARC) are advised on any quality or regulatory changes that will impact the Paris business.



Qualifications and experience required

* Must be fluent in both verbal and written English and French.
* Should be fully conversant with key regulations for In-vitro Diagnostic Devices.
* Experienced and conversant with current requirements for ISO 9001, ISO 13485 (including CMDCAS), 21 CFR Part 820.
* Qualified internal auditor to ISO 13485.
* Experience managing suppliers from a quality perspective.
* Previous experience in conducting process validation studies.
* Experience in the testing and validation of software would be a distinct advantage.
* Job Type: Contract



Required experience

* ISO 9001, ISO 13485 21CFR Part 820: 1 year
* In-vitro Diagnostic Devices: 1 year



Required language

Fluent French


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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