Quality Management Records Owner (33599)

Orion Group Life Sciences are looking for a Quality Management Records Owner for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with possibility of extension. This is a hybrid position, where you have to be 2-3 days onsite.

Job Purpose

In this role, you will be the owner of engineering change control / deviation/ CAPA records, assuring the completeness, accuracy and effectiveness of these records. You will ensure that all quality records are maintained in compliance with regulations and our client's quality standards and timelines for completion are met.

Main Responsibilities

• Change Controls: Manage the change control process, ensuring that all changes are documented, reviewed, and approved in accordance with regulations and our client's standards.
• Deviations: Document deviations, facilitate and lead Root Cause Analysis meetings to ensure that root causes are identified, and corrective / preventive actions are implemented.
• CAPAs: Ensure that corrective and preventive actions to address identified issues and prevent recurrence are identified, documented and tracked to completion.
• Collaboration: Work closely with various cross functional teams, to ensure the accuracy and completeness of quality records.

Requirements

• Bachelor's degree in a related field (e.g., Engineering, Life Sciences).
• Minimum 2 years of experience in handling Change controls / deviations / CAPAs, in a GMP regulated environment.
• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), Root Cause Analysis (RCA).
• Strong knowledge of regulatory requirements such as Eudralex Annex 15, FDA CFR 21 Part 210 and 211 and industry best practices related to quality records management.
• Fluent in English.
• Strong technical writing skills is a must.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of a team.
• Excellent communication and organizational skills.
• Experience in interacting with regulatory agencies is preferred.

If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, tim.browaeys@orioneng.com or contact Tim on 0044 7593448607

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Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.