Quality Assurance Manager
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Job Location:
Amsterdam - Netherlands
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
The role of the QA Manager supports the EU Qualified Person in the activities performed at the testing and release laboratory in Seqirus Netherlands B.V. and provide services to
Seqirus Netherlands B.V. in relation to the MIA for the importation of material into the EU.
Performs release of intermediate products for Seqirus Netherlands B.V. completes final product release checks and recommends disposition of the
finished product to the EU Qualified Person.
Provides QA oversight of the QC operations in Amsterdam including equipment and method validation.
Delegates for the EU Qualified Person in meetings and for defined activities
Quality Assurance Commercial / clinical batch release
Provides QA services to Seqirus Netherlands B.V. in relation to the MIA for the importation of material into the EU.
Performs release of intermediate products for Seqirus Netherlands B.V. completes final product release checks and recommends disposition of the finished product to the EU Qualified Person.
Generates Lot Release Protocols and Marketing Information Forms and tracks national competent laboratory submissions for batch release.
Delegates for the EU Qualified Person in meetings and for pre-defined activities
Supports new product introduction and implementation of the global projects and changes at Amsterdam site.
Prepares submits and tracks national competent laboratory submissions for batch release.
Supports data collation for the Qualified Person relating to IMP release
Quality Assurance QC support
Performs monthly checks on the QC facilities and data integrity.
Reviews and approves validation protocols and reports and oversees validation activities.
Attends weekly compliance meeting and regular tiered accountability meetings with QC.
Supports annual retain inspection and inspection of retains for complaints/deviations.
Reviews and approves procedures deviations (Level 1 and 2) OOS / OOT root cause investigations change controls and CAPAs for the QC laboratory.
QMS related activities
Actively involved in the site quality systems risk assessments and self-inspections.
Updates and Approves quality documentation relating to Seqirus Netherlands B.V.
Owns Reviews and approves procedures deviations (Level 1 and 2) Product Technical Complaints (minor and major) root cause investigations change controls and CAPAs related to Seqirus Netherlands B.V.
Promotes a cGMP compliant culture ensuring the highest standards are applied on the site observing current regulations and procedures.
Participates/supports in inspections audits and self-inspections recalls and mock-recalls.
Supports implementation of commitments.
Coordinates PQR activities and generates and approves PQR reports.
Generates LQMR packs and presents data as required and generates monthly compliance KPI data
Attends CoP meetings on behalf of Seqirus Netherlands B.V.
Education Requirements
Minimum: Bachelors degree (BSc) in sciences
Preferred: Eligible to meet the education requirements to be an EU QP
Experience Requirements
Minimum of 2 years of GMP industry experience; vaccines steriles and biological experience is preferable
Experience of managing Quality Assurance procedures preferred
About CSL Seqirus
CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being CSL.
You Belong at CSL
At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit our On the Front Line video to learn more about CSL Seqirus
Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
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