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Quality assurance specialist

Liscate
UNITED PARCEL SERVICE
Pubblicato il 10 settembre
Descrizione

Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow—people with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level.


Responsibilities

* Assist with the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and 13485 standards, and in compliance with the EU GMP and EU GDP Guidelines.
* Provide support to ensure compliance with local and regional legal requirements and regulatory authorities.
* Support license verification for customers, suppliers, and other entities working within UPS facilities (Pharmacy, GMP Area, etc.).
* Provide training, meet training needs, and coordinate staff trainings.
* Monitor, conduct, and coordinate self-inspections to ensure compliance with GMP, GDP, ISO 9001, and 13485 requirements.
* Assist in external audits when delegated by Healthcare Compliance (QA) Management or RP/QP.
* Participate in and evaluate supplier audits.
* Support investigations into non-conformances and customer complaints.
* Create Change Controls for significant changes and communicate them internally and to clients.
* Follow-up on CAPAs (Corrective and Preventive Actions).
* Decide on final disposition of finished, returned, and rejected products when delegated by Healthcare Compliance (QA) Management or RP/QP.
* Maintain documentation in accordance with EU GMP / EU GDP Guidelines and standards.
* Write/review Procedures, Work Instructions, and technical documents as assigned.
* Ensure operations (reception, inspection, storage, picking, shipping) comply with procedures and guidelines.
* Conduct Management Reviews under supervision of Healthcare Compliance (QA) Management.
* Support validation activities.
* Ensure equipment calibration and maintenance are performed.
* Collect temperature data and monitor environmental conditions.
* Promote a quality culture within the company.


Qualifications

* Bachelor’s Degree in Pharmacy, Chemistry, or CTF preferred.
* Good knowledge of English.
* Basic knowledge of Microsoft Office.
* Experience with ISO 9001 and/or ISO 13485 is an advantage.
* Knowledge of GMP and/or GDP guidelines is an advantage.
* Minimum 2 years of experience in pharmaceutical manufacturing, laboratories, or distribution companies.


Skills

* Ability to prioritize decisions with significant risk implications.
* Identify process gaps and recommend improvements.
* Manage risk assessment and mitigation effectively.
* Coordinate improvement projects across the company.
* Implement new processes impacting quality.
* Recommend training opportunities.
* Flexible working hours.
* Knowledge of electronic Quality Management Systems and Warehouse Management (e.g., WMS, GWS) is an advantage.

System (WMS, GWS, etc.) is an advantage.

* Employee Type
* Permanent

UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.

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