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Manager (m/f/d) Qualification, Validation and Quality Systems at xing

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

anning, execution and documentation of process validations and qualifications in accordance with regulatory requirements and internal specifications.
Planning and participation in machine and plant qualifications (IQ/OQ/PQ)
Creation, review and maintenance of validation plans, risk analyses, test protocols and validation reports.
Ensuring compliance with ISO 13485 and relevant regulatory requirements
Evaluation of changes in change management regarding their impact on existing validations
Support with deviations, complaints and CAPA measures related to validation activities
Further development of vali

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Responsibilities

anning, execution and documentation of process validations and qualifications in accordance with regulatory requirements and internal specifications.
Planning and participation in machine and plant qualifications (IQ/OQ/PQ)
Creation, review and maintenance of validation plans, risk analyses, test protocols and validation reports.
Ensuring compliance with ISO 13485 and relevant regulatory requirements
Evaluation of changes in change management regarding their impact on existing validations
Support with deviations, complaints and CAPA measures related to validation activities
Further development of vali