CSV Senior Validation Officer

Recruiter
SANOFI
Location
Essex
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Job Overview
Owner of Computer System Validation (CSV) lifecycle policies for IT, Automation and Laboratory Systems at Haverhill.

Provides life cycle management and coordination service for all aspects of computer system validation qualification and regulatory compliance activities at Haverhill.

Works to maintain and manage quality systems regarding GAMP and cGMP for the site.

Supports or performs internal and third party audits and inspections to assure compliance with regulations.

Responsibilities

- Be the lead CSV Quality & Compliance specialist for the implementation and operation of cGMP Computerised related Infrastructure at Haverhill Site.
- Provide quality and compliance support and expertise to Haverhill site projects and operations in support of a controlled environment and associated processes that meet the quality and compliance requirements of the site and the wider company.
- Apply best practice processes and procedures to support the efficient and compliant operation of infrastructure equipment and systems of work.
- Works in collaboration with Corporate IT, Site IT, MTS, Technical, Automation and Quality groups (QC and QA), maintains close contact with appropriate Centres of Excellence
- Has an excellent understanding of cGMP, GAMP and Annex 11 keeps up to date with relevant regulations and legislation, evaluates the affect of new or changed law and practices on current operations and suggests modifications when necessary
- Analyses complex issues and processes and applies own professional knowledge to identify areas for improvement
- Reviews and approves cGxP or regulatory reports/ protocols/ submissions and associated action plans. Provides guidance to others on their preparation.
- Makes appropriate recommendations and successfully effects change
- Acts as a source of technical expertise for others and gives advice on own area to other functions and employees
- Perform internal Compliance audits on for all IT, AT, Labs, Infrastructure and Applications.
- Participate in auditing third parties.
- Coordinates with related validation activity on site
- May supervise other staff and contractors as required to manage workload

Requirements & Qualifications

- Typically a graduate or equivalent in a science, engineering or pharmaceutical related subject area
- Will normally have obtained further professional qualifications
- Proven ability to lead project teams or host quality audits
- Demonstrated knowledge of working successfully within a Quality Management System and cGMP.
- Fully conversant with the requirements of cGMP, Annex 11, GAMP, 21CFR pt 11 as practised in the pharmaceutical industry.
- Will have worked on multiple GAMP related projects for multiple aspects of IT and/or process control systems and in various roles covering the full spectrum of activity - development of protocols; execution of validation; development of standards and operating procedures; providing expert advice on projects and in support of operational activity.
- Has detailed up to date regulatory knowledge in the field of computer systems validation.

Location Information

Commutable distance for Haverhill - within East Anglia

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients' needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.