Role 1 : Validation ConsultantRole 2 : Compliance ConsultantLocation : Basel, SwitzerlandDuration : PermanentValidation 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
Posts
