Senior Associate QA (GMP) (33694)

Orion Group Life Sciences are looking for a Senior Associate QA (GMP) (Validation / QRM / Quality Engineering) for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with a high possibility of extension. This is a hybrid position, where you have to be onsite 2 days a week. But this is also flexible.

Accountabilities

• Perform QA oversight for validation of equipment, automation and information systems and for Quality Risk Management.
• Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
• Provide guidance and direction to operations staff regarding compliance with quality policies, standards and procedures.
• Provide quality engineering support for testing strategies and quality investigations.

Main Responsibilities of the role

• 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, …).
  • Reviews and approves changes to M&E procedures (e.g. change over process, preventive and corrective maintenance).
• Device and combination product:
  • Manages our clients' device responsibilities and ensures alignment with GMP regulations.
• Quality Risk Management (QRM):
  • Represents QA in QRM activities (pFMEA, QRAES, Computer system compliance).
  • Ensures alignment of site Quality Risk activities with corporate policy and strategy.
  • Reviews quality risk assessment summary reports.
• 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.

Required Qualifications and skills

• 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.
• Experience with pharmaceutical industry.
• Experience with Non-conformances, CAPAs and Change Control.
• 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.
• Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
• Good understanding of quality engineering tools.
• Keeps overview but also deep dives when appropriate
• Effective communication skills at multiple levels and areas (inside and outside of Quality).
• Good attention to detail and excellent writing skills.
• Good decision making skills and ability to apply risk based approach.
• Team player, constructively working together towards solutions.

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.