Lee Baker Email & Phone Number | KEY SKILLS Strong IT/QA background Good communication, analytical and reporting skills Ability to be a team player, whilst retaining independence from a Quality perspective Experienced in managing Global Teams Clear understanding of GxP (GMP, GLP etc) standards as defined in the ICH Guidelines, EC Directives, FDA regulations and local laws Ability to hold technical conversations with IT specialists Experience of IT Quality and computer validation (CSV) within Pharma industry Experience of authoring, reviewing and approving Quality documentation (Polices/SOPs/Validation protocols/reports) Experience of ISPE GAMP Good Practice Guide on IT infrastructure control and Compliance and Network qualification Good working knowledge of FDA, EU GMP and ICH regulations, GLP and GMP (GxP) Experience of change management (ICH guideline Q10) Experience of being involved in audits and facing regulatory inspections Detailed knowledge of 21 CFR part 11 and experience of implementing it Knowledge of CSV validation strategies and life cycles and GAMP guidelines Review and approval of SAP Change Controls to ensure process compliance Compliance to GMP & SOX requirements

Lee Baker

KEY SKILLS Strong IT/QA background Good communication, analytical and reporting skills Ability t...
Oxford, Oxford, United Kingdom

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Lee Baker’s Email lee.baker@catalent.com

Lee Baker’s Phone Numbers +1 781-729-9920,+44 161 820 ****

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Lee Baker’s Location Oxford, Oxford, United Kingdom

Lee Baker’s Current Industry Evotec

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Work Experience

Evotec

IT Quality Group Leader

2022-01-01 00:00:00 - Present

Immunocore

Senior Manager, IT Compliance

2019-05-01 00:00:00 - 2022-01-01 00:00:00

Primevigilance

Associate Director Computer Systems QA

2018-02-01 00:00:00 - 2019-05-01 00:00:00

Patheon

Senior CSV Specialist

2013-10-01 00:00:00 - 2016-08-01 00:00:00

Apatech

Validation Engineer

2012-12-01 00:00:00 - 2013-10-01 00:00:00

Catalent Pharma Solutions Swindon

Equipment & Utilities Validation Team Leader

2007-01-01 00:00:00 - 2012-11-01 00:00:00

Cardinal Health

Equipment /Utilities Validation Engineer

2002-06-01 00:00:00 - 2007-06-01 00:00:00

Scherer Dds

Production Operator

1996-01-01 00:00:00 - 2000-01-01 00:00:00

3rd Battalion Royal Regiment Of Fusilers

HM Forces

1982-04-01 00:00:00 - 1994-10-01 00:00:00

Skills

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Languages

No Languages Available

FAQ About Lee Baker

Lee Baker is located at
Oxford, Oxford, United Kingdom

Lee Baker is a KEY SKILLS Strong IT/QA background Good communication, analytical and reporting skills Ability to be a team player, whilst retaining independence from a Quality perspective Experienced in managing Global Teams Clear understanding of GxP (GMP, GLP etc) standards as defined in the ICH Guidelines, EC Directives, FDA regulations and local laws Ability to hold technical conversations with IT specialists Experience of IT Quality and computer validation (CSV) within Pharma industry Experience of authoring, reviewing and approving Quality documentation (Polices/SOPs/Validation protocols/reports) Experience of ISPE GAMP Good Practice Guide on IT infrastructure control and Compliance and Network qualification Good working knowledge of FDA, EU GMP and ICH regulations, GLP and GMP (GxP) Experience of change management (ICH guideline Q10) Experience of being involved in audits and facing regulatory inspections Detailed knowledge of 21 CFR part 11 and experience of implementing it Knowledge of CSV validation strategies and life cycles and GAMP guidelines Review and approval of SAP Change Controls to ensure process compliance Compliance to GMP & SOX requirements

Lee Baker currently works in the Evotec |

No Languages Available

Lee Baker has prior
experience in the following industries:
Immunocore | Primevigilance | Patheon | Apatech | Catalent Pharma Solutions Swindon | Cardinal Health | Scherer Dds | 3rd Battalion Royal Regiment Of Fusilers

Lee Baker has the following professional experience:
Evotec | Immunocore | Primevigilance | Patheon | Apatech | Catalent Pharma Solutions Swindon | Cardinal Health | Scherer Dds | 3rd Battalion Royal Regiment Of Fusilers