Perform key QA responsibilities in equipment and packaging qualification, ensuring compliance with Corporate, Site, and Regulatory standards. Engage in equipment validation documentation review, provide quality support for testing strategies, and oversee master data accuracy in the electronic batch record platform (PASX). Collaborate on design and validation strategies, manage device responsibilities to align with GMP regulations, and conduct thorough review of technical change controls. Discover more about this exciting opportunity by reading further.

Over het bedrijf

Panda International

Volledige vacaturetekst

Perform QA oversight for validation of equipment and packaging qualification
Perform review and approval of equipment validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
Provide quality support for testing strategies and quality investigations.
Perform review and approval of master data in the electronic batch record platform (PASX).

Responsibilities

Process, equipment and IS validation
Agrees on strategy and provides guidance regarding design, characterization and validation in cooperation with PD / M&E / IS, while ensuring GMP quality and compliance.
Reviews and approves validation documentation.
Maintenance & Engineering support
Reviews and approves changes to equipment (e.g. parameter changes, like for like assessments, …)
Device and combination product
Manages device responsibilities and ensures alignment with GMP regulations.
PASX master data
Review and approved master data in PASX system as QA.
Change control
Performs final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.
Functions as QA SME and collects input from different QA areas to complete the QA assessment for technical changes.
Deviation management
Functions as QA contact for deviation records.

Qualifications
MUST Requirements

MBO or Bachelor’s degree in Life Sciences or process technology related field or the equivalent combination of education and/or experience.
Typically 3+ years of relevant experience in the pharmaceutical or medical device industry with experience in Equipment and Automation Validation.
Good Manufacturing Practice (GMP), equipment and automation/IS validation, computer compliance (Annex 11, Part 11) knowledge with the ability to interpret and apply in mainly routine cases.
Manufacturing and/or Quality analytical processes and operations.
Fluent in English language.

Preferred Requirements

Experience with pharmaceutical industry
Experience with Deviations and Change Control

Interested? Send your CV to Daria at via de button "Solliciteer nu" op deze pagina. or call +31202044502 for more info.

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