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At Aspeya we strive to make a positive difference to the lives of patients and consumers through science, insight, and innovation.
We are on a journey to empower healthier lifestyles and target specific unmet needs. We do this by being innovative, optimizing formulas, and applying rigorous scientific standards.
We trust a bold and confident approach, without compromising integrity. Join us and be part of a dynamic, future-thinking environment where your contributions can make a positive difference to people’s lives.
About your role
As our Quality Operations Manager, you will play a pivotal role in the deployment, integration and operationalisation of our QMS.
You will be at the forefront of maintaining compliance with internal and external policies, procedures, specifications, and regulatory requirements.
If you are looking for the opportunity to lead change and take ownership, this could be a great next step in your career.
Key responsibilities include, but aren’t limited to:
* Manage core QMS functionalities including audit management, change management, deviation management, document management, nonconformance/CAPA, and training management.
* Ensure the validation and deployment of QMS IT applications are suitable for intended purposes.
* Conduct internal audits to ensure compliance with regulatory requirements and industry standards.
* Support external audits/inspections as a QA subject matter expert (SME), developing inspection readiness operating models.
* Define and promote proper ownership of business processes with identified SMEs.
* Oversee the archival process in accordance with established procedures.
* Define quality key performance indicators (KPIs) and support metrics trending and reporting for Quality Management Review.
* Drive a quality culture that promotes continual improvements to enhance QMS efficiency and effectiveness.
Does this sound like you?
* Proven track record as a subject matter expert in QMS management. Our preference would be for candidates with hands-on experience with Veeva Vault.
* Demonstrable experience in rolling out QMS modules across an organisation.
* Ability to navigate large complex organizations and establish strong cross-functional collaborations.
* Excellent communication skills and a keen interest in developing training materials.
* Strong engagement skills to foster a quality mindset and advocate for continual improvement.
* Ability to independently develop and drive Quality programs and initiatives to completion.
Apply
Ready to make a difference? Join us at Aspeya and be part of a team that's transforming healthcare. Apply now and let's innovate together!
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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