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Quality Assurance Manager - CSV at Phyton Biotech GmbH

victoria, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

16 Dec, 26

Salary

80000.0

Posted On

17 Sep, 26

Experience

12 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

Support and continuous development of the document management system (DMS) D3 from d.velop, including necessary system validations.
Ensuring compliance with GMP requirements
Creation, review and approval of quality-relevant documents
Processing and evaluation of deviations, CAPAs, change controls and risk analyses, qualification and validation documentation, especially for computer-based systems and IT infrastructure
Review, evaluation and approval of CSV documents in accordance with applicable regulations and internal guidelines.
QA support for the validation of computerized systems
Monitoring, analysis and optimization of existing quality management processes
Conducting and supp

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Responsibilities

Support and continuous development of the document management system (DMS) D3 from d.velop, including necessary system validations.
Ensuring compliance with GMP requirements
Creation, review and approval of quality-relevant documents
Processing and evaluation of deviations, CAPAs, change controls and risk analyses, qualification and validation documentation, especially for computer-based systems and IT infrastructure
Review, evaluation and approval of CSV documents in accordance with applicable regulations and internal guidelines.
QA support for the validation of computerized systems
Monitoring, analysis and optimization of existing quality management processes
Conducting and supp