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QA Auditor
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Support
Projektbeschreibung
One of our clients, a multinational company in the pharmaceutical industry currently requires a QA Auditor
Start: ASAP
Length: 3 months (replacement but can be longer)
Location: South of Brussels
MISSION DESCRIPTION:
The Quality Assurance GCLP Auditor's primary responsibilities include:
* Support all aspects of out contractors quality management in alignment with the GxP, local and corporate requirements
* Follow-up Quality Alerts resulting from an audit
* Lead/participate in audits, organize it, perform it and follow action plans
* Audit R&D site to assure compliance to global rules.
Travel time to external collaborators is between 30 and 40%
Two options are possible for the position: Temporary Full time positionor by mission (one audit= one mission). Per one audit, we mean from the planification to the closure of the audit (date to define, preparationof the audit, audit to perform in 2 days on site, report to write andfollow-up of CAPA).
KEY RESPONSIBILITIES:
* Build and maintain beneficial working relationships with all internaland external customers.
* Prepare, schedule, perform and report GCLP audits of internal andexternal clients.
* Present audit observations to project team and management through executive summaries.
* Generate and maintain audits and perform follow-up with auditees
No budgetary control responsibilities.
* Must be able to address complex problems, which can require direct corrective action but often need to be solved.
* Must keep management informed of potential compliance risks identified during audits.
* Must have an aptitude for facilitating a team environment as a memberof the GCLP QA team and working independently toward goals.
Leads and mobilizes stakeholders in order to immediately investigateand resolve critical quality and compliance issues.
PREREQUISITES:
Education: BS or BA in a relevant technical discipline, preferably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy.
Knowledge & Experience: 5 - 10 years of Experience in Quality orcompliance environment in a pharmaceutical company and a previousexperience in audit activities is an asset as well as the knowledge ofthe GCLP guideline from BARQA and/or EMA/INS/GCP/532137/2010.
* Excellent organizational skills and attention to detail, ability tofunction in an atmosphere of constant change with detailed accuracy.
* Strong verbal and written skills in both English and French(preferably)
* Ability to establish and maintain working relationships withmulti-cultural teams
* Ability to lead the process to generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions andimplement decisions.
* Computer skills in Microsoft Office applications and the ability toquickly and easily learn new applications.
* Able to interact with peers, subordinate and senior personnel in multidisciplinary environment.
* Able to prioritize and decide appropriate course of actions and to effectively implement decisions.
* Capable of working without direct supervision.
Training Period: one audit will be performed with a senior auditor
Tags: GMP, GXP, Quality Assurance, QA, Audits, Pharmaceutical, Pharmaceutique
Start: ASAP
Length: 3 months (replacement but can be longer)
Location: South of Brussels
MISSION DESCRIPTION:
The Quality Assurance GCLP Auditor's primary responsibilities include:
* Support all aspects of out contractors quality management in alignment with the GxP, local and corporate requirements
* Follow-up Quality Alerts resulting from an audit
* Lead/participate in audits, organize it, perform it and follow action plans
* Audit R&D site to assure compliance to global rules.
Travel time to external collaborators is between 30 and 40%
Two options are possible for the position: Temporary Full time positionor by mission (one audit= one mission). Per one audit, we mean from the planification to the closure of the audit (date to define, preparationof the audit, audit to perform in 2 days on site, report to write andfollow-up of CAPA).
KEY RESPONSIBILITIES:
* Build and maintain beneficial working relationships with all internaland external customers.
* Prepare, schedule, perform and report GCLP audits of internal andexternal clients.
* Present audit observations to project team and management through executive summaries.
* Generate and maintain audits and perform follow-up with auditees
No budgetary control responsibilities.
* Must be able to address complex problems, which can require direct corrective action but often need to be solved.
* Must keep management informed of potential compliance risks identified during audits.
* Must have an aptitude for facilitating a team environment as a memberof the GCLP QA team and working independently toward goals.
Leads and mobilizes stakeholders in order to immediately investigateand resolve critical quality and compliance issues.
PREREQUISITES:
Education: BS or BA in a relevant technical discipline, preferably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy.
Knowledge & Experience: 5 - 10 years of Experience in Quality orcompliance environment in a pharmaceutical company and a previousexperience in audit activities is an asset as well as the knowledge ofthe GCLP guideline from BARQA and/or EMA/INS/GCP/532137/2010.
* Excellent organizational skills and attention to detail, ability tofunction in an atmosphere of constant change with detailed accuracy.
* Strong verbal and written skills in both English and French(preferably)
* Ability to establish and maintain working relationships withmulti-cultural teams
* Ability to lead the process to generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions andimplement decisions.
* Computer skills in Microsoft Office applications and the ability toquickly and easily learn new applications.
* Able to interact with peers, subordinate and senior personnel in multidisciplinary environment.
* Able to prioritize and decide appropriate course of actions and to effectively implement decisions.
* Capable of working without direct supervision.
Training Period: one audit will be performed with a senior auditor
Tags: GMP, GXP, Quality Assurance, QA, Audits, Pharmaceutical, Pharmaceutique
Projektdetails
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