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Qa specialist

Vira
Aptar
Inserat online seit: Veröffentlicht vor 12 Std.
Beschreibung

Who we are

At Aptar, we use insights, design, engineering and science to create innovative packaging technologies that build brand value for our customers, and, in turn, make a meaningful difference in the lives, looks, health and homes of people around the world. Every day, Aptar creates \"a-ha moments\" for its customers and their consumers and patients by continually bringing innovations to market that convert non-dispensing packaging into breakthrough product-dispensing systems, including those that give people more effective ways to put on their favorite fragrance, kids the opportunity to pour ketchup without making a mess and patients connected technologies that help them more easily adhere to treatment. We have manufacturing facilities in North America, Europe, Asia and South America and over 14,000 dedicated employees in some 20 countries.

You should work here because we

* Attract and develop high performing people.
* Promote a diverse and inclusive work environment.
* Allow for failure by allowing people to make mistakes through an open and trusting environment.
* Invest in the development of employees through local, regional and global career opportunities.
* Contribute to the communities where we reside.

What's new with Aptar

We have an exciting position open in Aptar Mezzovico: QA Specialist, reporting to Head of Quality Assurance. This position will be based in Mezzovico.

This is how your journey begins

* You will take ownership of all Quality Assurance aspects within company projects, with a strong focus on qualification and validation (e.g., moulding and assembly processes, new/modified manufacturing processes and environments, software systems).
* You will lead and support quality-related activities in projects by motivating collaborators, working across cross-functional and cross-site teams, and documenting decisions with clear justifications.
* You will apply relevant compliance standards (FDA, GMP, ISO 13485, ISO 15378, ICH) to ensure alignment with Aptar internal requirements and customer expectations.
* You will ensure the preparation, accuracy, and integrity of quality documentation related to qualifications and validations, maintaining traceability and compliance across all records.
* You will plan and prioritize qualification/validation project phases (e.g., DQ/IQ/OQ/PQ, risk assessments, protocols/reviews, Validation Master Plans) to meet critical deadlines, applying project management skills.
* You will investigate and resolve deviations and anomalies using a structured problem-solving approach, proactively proposing effective solutions.
* You will evaluate process data objectively with statistical tools to support risk-based and compliance-driven decisions.
* You will act as a key representative in managing qualification/validation strategies and activities with customers, notified bodies, regulatory authorities, and internal stakeholders.
* You will support the Quality Assurance team in other QA activities and processes (e.g., CAPA, Change Control, Complaints) as well as in Continuous Improvement initiatives.

What you will bring on the journey

* Technical background (ideally with a degree in Mechanical Engineering or a related field)
* Background in validation and qualification within pharmaceutical and/or medical devices environments
* Good knowledge of pharmaceutical regulations such as GMP, ISO 13485, ISO 15378, FDA, ICH
* Experience in industrial manufacturing processes (preferably components assembly and plastic moulding), quality control, and project management
* Ability to use statistical and data analysis tools
* Strong quality mindset with a risk-based decision-making approach
* Proven leadership, teamwork and communication skills
* Good command of English, both spoken and written

What we offer

* An exciting, diverse and value based working environment
* Corporate university programs offering personal development and training opportunities.
* Competitive base salary and performance-based bonus plan.
* Contribute to the communities where we reside.

Be You. Be Aptar

Aptar is an equal opportunities employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age,

sex, disability, sexual orientation, race, religion or belief.

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