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QA Speciailst (Document Review)
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Consultant
Projektbeschreibung
Quality assurance consultant For one of our clients, we are looking for a Quality Assurance specialist to assist a team of QA experts from September until the end of the year.
As part of the Development Quality team, the consultant will participates to:
Quality review of executed batch records for drug substance and drug product for clinical trial supplies Release of raw materials used in production of drug substance and drug product for clinical trials
Quality review of analytical methods and analytical validation protocols and reports for drug substance and drug product in development
Quality review of analytical methods transfer protocols and reports for drug substance and drug product in development.
Quality review of stability protocols and reports for drug substance and drug product in development Writing Quality Assurance Agreement between CMO and Development Quality PharmaSciences
The consultant will assist QA department (chemical), manage GMP from phase 1 to end development. This involves from the release of raw material, revision of analytical methods, the review of documents that are not per se related to projects.
You will integrate a team of 4 people.
BUSINESS KNOWLEDGE AND TECHNICAL EXPERTISE
Minimum 5 years experience in pharmaceutical regulated environment. Must be knowledgeable in QA and technical requirements of pharmaceutical development processes, A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential. QA/compliance experience in IMP manufacturing, facility operation, laboratory compliance and quality systems. Areas of expertise should include compliance, quality assurance, quality control, validation, technical services, and an in-depth knowledge of at least one scientific discipline related to pharmaceutical sciences.
MANAGEMENT AND LEADERSHIP SKILLS
Good interpersonal, verbal, and written communication and presentation skills. Effectively work under minimal supervision. Good teamwork track record Must have strong, organization and analytical skills. Must be fluent in French and English, other languages are an asset Facilitator, influencer and planner Thorough understanding of business and cultural drivers Good knowledge of cGMP and relevant regulatory requirements (eg US, European, Japanese) Identifies risk and propose corrective actions Inspire confidence trough influencing skills and technical ability in a CMC development environment Mobilize relevant colleagues, business partners and other skate holders when facing obstacles
Knowledge:
Knowledge of FMEA, or other complex problem solving tools
Experience of participation in failure investigations
Familiarity with risk analysis techniques
Local: Nivelles
Contract: from September till December 2017
As part of the Development Quality team, the consultant will participates to:
Quality review of executed batch records for drug substance and drug product for clinical trial supplies Release of raw materials used in production of drug substance and drug product for clinical trials
Quality review of analytical methods and analytical validation protocols and reports for drug substance and drug product in development
Quality review of analytical methods transfer protocols and reports for drug substance and drug product in development.
Quality review of stability protocols and reports for drug substance and drug product in development Writing Quality Assurance Agreement between CMO and Development Quality PharmaSciences
The consultant will assist QA department (chemical), manage GMP from phase 1 to end development. This involves from the release of raw material, revision of analytical methods, the review of documents that are not per se related to projects.
You will integrate a team of 4 people.
BUSINESS KNOWLEDGE AND TECHNICAL EXPERTISE
Minimum 5 years experience in pharmaceutical regulated environment. Must be knowledgeable in QA and technical requirements of pharmaceutical development processes, A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential. QA/compliance experience in IMP manufacturing, facility operation, laboratory compliance and quality systems. Areas of expertise should include compliance, quality assurance, quality control, validation, technical services, and an in-depth knowledge of at least one scientific discipline related to pharmaceutical sciences.
MANAGEMENT AND LEADERSHIP SKILLS
Good interpersonal, verbal, and written communication and presentation skills. Effectively work under minimal supervision. Good teamwork track record Must have strong, organization and analytical skills. Must be fluent in French and English, other languages are an asset Facilitator, influencer and planner Thorough understanding of business and cultural drivers Good knowledge of cGMP and relevant regulatory requirements (eg US, European, Japanese) Identifies risk and propose corrective actions Inspire confidence trough influencing skills and technical ability in a CMC development environment Mobilize relevant colleagues, business partners and other skate holders when facing obstacles
Knowledge:
Knowledge of FMEA, or other complex problem solving tools
Experience of participation in failure investigations
Familiarity with risk analysis techniques
Local: Nivelles
Contract: from September till December 2017
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Organisation/Management