We are looking for Validation consultants and Compliance consultants – 2
opportunities in Basel, Switzerland
I have given further detail of the requirement below.
Role 1 : Validation Consultant
Role 2 : Compliance Consultant
Location : Basel, Switzerland
Duration : Permanent
Validation Lead Job
Description:
Participate in the development
of strategic compliance deliverables to support applicable regulations and
internal policies and to ensure systems to be developed adhere to corporate SDLC
methodology. drive understanding and adoption of Quality and Compliance
standards. Ensure Quality & Compliance requirements are considered in any
initiative or major change request. Ensure the compliance deliverables are
updated and kept current with all applicable changes. Work with IT and business
teams within HCS/CLS to drive/maintain/create Quality program. Align the
development methodology with Compliance plans, policies and procedures.
Effectively manage ongoing change control process (interface to IT support,
impact analysis, release mgt, data changes, testing etc.). Build strong
relationships with franchise quality business owners.
Qualifications
-
Strong years experience in
Quality & Compliance with a Bachelors degree.
-
Experience in FDA regulated
environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards
and Risk based validation.
-
Experience in Computer system
validation.
-
Experience in writing and
executing documentation for all aspects of the validation deliverables (etc.
Requirements, Compliance/validation Plans, test protocols, Test Summary reports
and Compliance/validation reports.
-
Experience in reviewing system
test and user acceptance test scripts, Traceability matrix and Design Specs.
-
Experience in Software
Development Lifecycle (SDLC).
-
Experience in QA Methodologies,
designing, reviewing and approving Test Plans, systems and UAT test scripts and
Test procedures.
-
Experience in Change
Control.
-
Experience on various FDA
standards (21 CFR Part 11, 210, 211, 820)
-
Experience is creation of
SOPs.
-
Knowledge of FDA guidance’s and
industry standards (i.e., GAMP)
-
Hands on experience in HP
Quality Center and QTP.
-
Strong verbal and written
communication skills.
-
Able to work as a team player,
lead a team or accomplish tasks without supervision.
-
Ability to work with remote
teams and support several changes/projects simultaneously.
-
Flexibility to work with an
onshore/offshore model.
-
Knowledge working with systems;
such as, SAP, Red Prairie and data management systems
Compliance Lead Job
Description:
Participate in the development of strategic compliance deliverables to
support applicable regulations and internal policies and to ensure systems to be
developed adhere to corporate SDLC methodology. drive understanding and adoption
of Quality and Compliance standards. Ensure Quality &
Compliance requirements are considered in any initiative or major change
request. Ensure the compliance deliverables are updated and kept current with
all applicable changes. Work with IT and business teams within HCS/CLS to
drive/maintain/create Quality program. Aligns the development methodology with
Compliance plans, policies and procedures. Effectively manage ongoing change
control process (interface to IT support, impact analysis, release mgt, data
changes, testing etc.). Build strong relationships with franchise quality
business owners.
Qualifications
- Strong experience in Quality & Compliance with a Bachelors degree.
- Experience in FDA regulated environment with good understanding of cGxP
(cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.
- Experience in Computer system validation.
- Experience in writing and executing documentation for all aspects of the
validation deliverables (etc. Requirements, Compliance/validation Plans, test
protocols, Test Summary reports and Compliance/validation reports.
- Experience in reviewing system test and user acceptance test scripts,
Traceability matrix and Design Specs.
- Experience in Software Development Lifecycle (SDLC).
- Experience in QA Methodologies, designing, reviewing and approving Test
Plans, systems and UAT test scripts and Test procedures.
- Completed a compliance project deployment from conception to implementation.
- Experience Managing projects.
- Experience on various FDA standards (21 CFR Part 11, 210, 211, 820)
- Experience is creation of SOPs.
- Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
- Hands on experience in HP Quality Center and QTP.
- Strong verbal and written communication skills.
- Able to work as a team player, lead a team or accomplish tasks without
supervision.
- Ability to work with remote teams and support several changes/projects
simultaneously.
- Knowledge working with temperature sensors
About the Employer
The employer is a multibillion dollar global IT Services company which
specializes in providing IT services, outsourced research and development,
infrastructure outsourcing, business process outsourcing (BPO) and business
consulting services to many global Fortune 500 clients across various verticals
like financial services, retail, transportation, manufacturing, healthcare
services, energy and utilities, technology, telecom and media.
About US
Avance Consulting is one of the UK’s fastest growing talent acquisition
companies. Head quartered in London, we are a global reach agency with a large
presence in UK, Europe, US and India.
If you are interested in the role of
Validation consultants and
Compliance consultants roles please get in touch with us immediately at
subbu@avanceservices.co.uk /
Phone No: +
44-20-7177-0031 Ext: 529
