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Senior QA & Project Manager (m/w/d)

Remote:

Full Remote

Salary:

80 - 80K yearly

Experience:

Senior (5-10 years)

Work from:

Austria

Offer summary

Qualifications:

MSc in Pharmacy, Chemistry, Biology or Chemical Engineering, At least 5 years in pharmaceutical GxP environment, Knowledge of GMP/cGMP/21 CFR requirements, Strong management and organizational skills.

Key responsabilities:

Provide QA support to teams
Conduct audits and inspections

Fresenius Kabi Austria https://www.fresenius-kabi.com/de-at/

1001 - 5000 Employees

See all jobs

Job description

Your tasks

QA Support and Advice: Provide support and guidance to central teams, local QA, QC, and plant teams to address compliance gaps and enhance local knowledge and skills.
Hands-On Approach: Collaborate with organizations to prepare documentation, ensuring knowledge transfer and skill development at the plant level.
Audits and Inspections: Conduct onsite and remote assessments in an audit/inspection style to verify compliance with standards and readiness for authority inspections.
Participate in global quality system harmonization initiatives.
Develop and review global SOPs.
Support supplier audits and ensure global SOPs and processes are implemented.
Prepare organizations for regulatory audits, conduct pre-audits, and provide support during and after inspections.
Central Function Activities: Manage tasks such as SOP distribution, eDMS transfers, KPI reviews, audit outcome reporting, quality culture projects, training setups, PQR reviews, and SharePoint updates.
Lead harmonization and critical business projects.
Regulatory Monitoring and Improvement: Track GxP/ISO regulatory developments and propose quality improvement initiatives to local and QA management.
Documentation: Prepare and revise quality management documents in line with GMP, ICH, ISO, and applicable national/international legislation.
Quality Initiatives: Execute quality improvement projects in close collaboration with Competence Centers.

Our expectations

Educational skills: MSc in Pharmacy, Chemistry, Biology, Chemical engineering or other relevant education.
At least 5 years of experience the pharmaceutical GxP environment and proven knowledge on the requirements and application of pharmaceutical quality systems, GMP/cGMP/21 CFR guidelines, WHO GMP and ISO 9001/13485.
Management skills are important as well as being able to organize and coordinate multiple tasks in several organizations.
In order to be successful in this position we are looking for a person with good communication skills, confident in English and as well strong integrity.
Routine travels for on-site support of organizations.

We offer

International challenges in a dynamic corporate environment
Corporate social events
Attractive performance-related salary package (annual gross salary starting at € 80.000,-, overpayment depending on occupational skills and experience)

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