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Quality Assurance Specialist
Eingestellt von Michael Bailey Associates - Zurich
Gesuchte Skills: Support
Projektbeschreibung
Quality Assurance Specialist - 12 months Contract, Basel
We are looking for a quality specialist to support management of QA/QC processes and procedures, product responsibility, validation and qualification.
Major Accountabilities:
. Provides scientific and technical expertise on QA/QC procedures within the quality department and other organizations
. Maintains and adheres to cGMP, SOPs, Rolling Review, CAPA
. Prepares, participates in and conducts authority inspections and audits
. Ensure uniform GMP standards through regular exchange with central QA function
. Initiate revision, validation and improvement of GMP documents eg testing monographs, SOP's, qualification and validation documents
. Provide input to health authority requests
. Manage investigations regarding product quality (eg OOS/OOE, deviations, customer complaints)
. Procures validation support; supports launches
. Local and global project participation or lead
. Maintains state-of-the-art knowledge of Health Authority requirements, trends, technologies, processes and systems.
Requirements:
. Implementation of the quality process improvements with impact on time, quality and costs
. Provide expertise and support the technical operations and quality department.
. Keep timelines (eg availability of documentation, qualification, validation, batch release, investigations)
. Experience with authority inspections and audits
. Successful implementation of cross-functional projects.
. University or academic degree in Chemistry, Biology, Pharmacy or equivalent
Languages: German and English
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
We are looking for a quality specialist to support management of QA/QC processes and procedures, product responsibility, validation and qualification.
Major Accountabilities:
. Provides scientific and technical expertise on QA/QC procedures within the quality department and other organizations
. Maintains and adheres to cGMP, SOPs, Rolling Review, CAPA
. Prepares, participates in and conducts authority inspections and audits
. Ensure uniform GMP standards through regular exchange with central QA function
. Initiate revision, validation and improvement of GMP documents eg testing monographs, SOP's, qualification and validation documents
. Provide input to health authority requests
. Manage investigations regarding product quality (eg OOS/OOE, deviations, customer complaints)
. Procures validation support; supports launches
. Local and global project participation or lead
. Maintains state-of-the-art knowledge of Health Authority requirements, trends, technologies, processes and systems.
Requirements:
. Implementation of the quality process improvements with impact on time, quality and costs
. Provide expertise and support the technical operations and quality department.
. Keep timelines (eg availability of documentation, qualification, validation, batch release, investigations)
. Experience with authority inspections and audits
. Successful implementation of cross-functional projects.
. University or academic degree in Chemistry, Biology, Pharmacy or equivalent
Languages: German and English
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges