Associate QA (GMP)

Job title:

Associate QA (GMP)

Company:

SIRE Group

Job description

Location: Breda, Noord-Brabant | Sector: Biotechnology | Start Date: 1/6/2025 | Job ref: 54194The Company
Our client is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions.Role Description
Provide QA oversight for equipment validation, packaging qualification, testing strategies, quality investigations, and master data review in PASX, ensuring compliance with corporate, site, and regulatory standards.Responsibilities
– Provide guidance and ensure GMP compliance for process, equipment, and IS validation, including review and approval of validation documents.
– Review and approve equipment changes, such as parameter updates and like-for-like assessments.
– Manage device responsibilities, ensuring alignment with GMP regulations.
– Review and approve master data in the PASX system as QA.
– Oversee technical change controls, perform QA assessments, and act as the QA contact for deviation records.Requirement
– MBO or Bachelor’s degree in Life Sciences, Process Technology, or a related field, or equivalent education and experience.
– Minimum of 2 years of relevant experience in the pharmaceutical or medical device industry, with expertise in Equipment and Automation Validation.
– Strong knowledge of GMP, equipment and automation/IS validation, and computer compliance (Annex 11, Part 11), with the ability to apply it in routine scenarios.
– Familiarity with manufacturing and quality analytical processes and operations.
– Proficient in English.Other Information
Are you interested? Feel free to contact me!54194

Expected salary

Location

Breda, Noord-Brabant

Job date

Tue, 07 Jan 2025 23:15:11 GMT

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