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QA Compliance Validation Consultant
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Consultant
Projektbeschreibung
One of our clients, a multinational pharmaceutical company, currently requires a QA Compliance Validation Consultant
Start date: February 2014
Duration: 6 months, renewable
Location: South of Brussels
Job Purpose
- Ensure QA Validation Periodic Review activities for NPI
- Take the responsibility for QA in Validation
- Assure regulatory inspection readiness (L2 - L3/L4)
Key Responsibilities
- Review and approve the system periodic review
- Ensure the compliance in validation activities
- Approve the validation documentation regarding the GMP requirements and the GSKBio procedures: Periodic Review - Validation master plan
- Approbation of risk assessment
- Ensure timely escalation to Mgt of critical issues during Periodic Review exercise
- Review and approve the potential CAPA plan issued from Periodic Review
- Perform internal audit (L2) of validation activities
- Ensure implementation of validation related commitments towards internal/external inspections
- Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
Education
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
Knowledge
- Good interpersonal relationship skills
- Good oral and written communication skills in French & English
- Problem solving and achievement oriented
Previous Experience
- At least 5 years of experience in Prod., Valid. or QA in a biopharmaceutical industry
- Experience in auditing techniques
Start date: February 2014
Duration: 6 months, renewable
Location: South of Brussels
Job Purpose
- Ensure QA Validation Periodic Review activities for NPI
- Take the responsibility for QA in Validation
- Assure regulatory inspection readiness (L2 - L3/L4)
Key Responsibilities
- Review and approve the system periodic review
- Ensure the compliance in validation activities
- Approve the validation documentation regarding the GMP requirements and the GSKBio procedures: Periodic Review - Validation master plan
- Approbation of risk assessment
- Ensure timely escalation to Mgt of critical issues during Periodic Review exercise
- Review and approve the potential CAPA plan issued from Periodic Review
- Perform internal audit (L2) of validation activities
- Ensure implementation of validation related commitments towards internal/external inspections
- Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
Education
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
Knowledge
- Good interpersonal relationship skills
- Good oral and written communication skills in French & English
- Problem solving and achievement oriented
Previous Experience
- At least 5 years of experience in Prod., Valid. or QA in a biopharmaceutical industry
- Experience in auditing techniques
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Organisation/Management