FDA/Gamp 5 specialist

Cork  ‐ Onsite
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Description

Duration: 12 months

Work Location: Cork, Ireland

Detailed JD is below -

BSc. Degree (Technology related preferred) with 5+ years technology or information systems experience

Strong knowledge of business processes across manufacturing, supply chain & quality

Experience with Computer Systems Validation preferred

Knowledge of 21 CFR Part 11 and EU Annex 11 regulations preferred

Independent problems solving skills

Skills & Experience Required

Good verbal and written communication skills.

Good organizational skills.

Must have good interpersonal skills. Position will involve a lot of interdepartmental interaction and coordination.

Must possess a thorough understanding of GxP, in addition to FDA and International requirements for computer validation and Part 11/Annex 11 requirements.

Must possess a thorough understanding of current industry guidance, including GAMP 5

Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects.

Skills & Experience Required

Develop and executes all validation project deliverables

Capable of owning issues and driving them to resolution

Capable of reviewing validation protocols, Test scripts and traceability Matrix

Must possess a thorough understanding of GxP, in addition to FDA and International requirements for computer validation and Part 11/Annex 11 requirements.

Must possess a thorough understanding of current industry guidance, including GAMP 5

Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects.

Good verbal and written communication skills.

Good organizational skills.

Must have good interpersonal skills. Position will involve a lot of interdepartmental interaction and coordination.

Start date
n.a
From
Templeton and Partners
Published at
17.10.2018
Project ID:
1650464
Contract type
Freelance
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