Senior Associate QA (GMP) (33661)

Orion Group Life Sciences are looking for a Senior Associate QA (GMP) (Global Distribution Quality) (GDQ) for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with a high possibility of extension. This is a hybrid position.

What you will do

• The Senior Associate QA position will implement and oversee global product distribution and transportation from our clients' Global Supply Hubs to our clients' global markets.
• Provide QA oversight of QA activities for Global Supply Chain operations.
• Act as QA contact on new projects such as RDH (Regional Distribution Hub).

Main Responsibilities of the role

• Perform QA Contact role on the Non-conformance, change control, corrective and preventive action, effective verification and documentation, as well as QA triage of Distribution complaints Works closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP.
• Act as subject matter expert (SME) for transportation related Quality Processes.
• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Collaborate with the 3rd Parties to ensure adherence to service levels, identifying performance improvement opportunities in alignment with the Operations READ framework (reliability, efficiency, agility, differentiation).
• Understand and incorporate risk management strategy into overall supply chain strategy.
• Perform cGMP process, procedure, document and record review, and approval, including but not limited to deviations, CAPAs, change controls, risk assessment, and validation records.
• Provide support for logistic service provider and transportation service provider oversight.
• Support the Quality Unit during audits and inspections.
• Support internal/external audits and inspections as part of the audit/inspection team.
• Perform routine Quality Assurance assessments of operations and provide direct oversight.
• Provide quality expertise and guidance to operational staff and within cross functional teams of our client.
• Taking part in operational improvement initiatives, programs, and projects
• Develop solutions that are thorough, practical, and consistent with functional objectives
• Work under minimal supervision in line with our clients' Values and Leadership Attributes.

Required Qualifications and skills

• Bachelor's degree in science or engineering and 2+ years of professional experience in related fields.
• Strong continuous improvement mindset and lean practices experience.
• Understanding of end-to-end supply chain business processes.
• Experience in project management across multiple departments and geographies.
• Quick process understanding, insight and visualizing.
• Strong analytical and problem-solving skills.
• Independent self-starter, able to work autonomously, under pressure and in teams.
• GMP/GDP knowledge and understanding of pharmaceutical regulations.
• Energetic, detail oriented, highly motivated with a "can do" outlook.
• Change management skills.
• Ability to communicate across all levels of the organization.
• Effective written and verbal communication skills.
• Experience with Microsoft Office Tools including Excel, Word, and PowerPoint.
• Ability to multi-task and prioritize
• Familiarity with logistics processes of parcel, transport, and warehousing providers.
• Experience in Validation/Qualification of processes, equipment, and facilities.
• Strong technical writing skills.

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.