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Job Summary
As Healthcare Quality Assurance (QA) Supervisor, you will lead the Quality department in our state-of-the-art Healthcare distribution center.
You will communicate quality policy and objectives, ensuring they are implemented and maintained locally. Your responsibilities include developing operating procedures, training the QA team and internal clients on operating procedures and regulatory topics. You will assess and maintain quality documents in alignment with EU GDP / GMP and ISO 9001 / ISO 13485 standards. Participation in audits (internal, client, supplier, agency) and various projects, such as implementing new clients or systems, is expected. Maintaining knowledge of healthcare quality regulations and assessing risks related to the storage and transportation of healthcare products will be part of your role, with escalation to higher management as needed.
Responsibilities
* Implement and maintain the Quality Management System (QMS) in compliance with EU GMP / GMP Guidelines and ISO 9001 and ISO 13485 standards.
* Support compliance with local and regional legal requirements and regulatory authorities.
* Make recommendations to the Responsible Person (RP) / Qualified Person (QP), QA Manager, and EU QA / RA Director regarding resources needed for the QMS and commitments to clients.
* Decide on the final disposition of finished products, including returns, rejections, recalls, or falsified products.
* Promote a quality culture within UPS Healthcare Logistics & Distribution (HLD).
* Participate in and follow up on audits, support investigations into non-conformances and customer complaints, and oversee CAPAs.
* Assess and approve changes related to processes and projects.
* Manage direct reports through risk assessment, task delegation, performance evaluation, skills development, and career planning.
Qualifications
* Education: Bachelor’s or Master’s degree in Pharmacy, Chemistry, Pharmaceutical Chemistry, or Technology.
* Knowledge of EU GMP / GDP guidelines is preferred. Minimum of 3 years’ experience in pharmaceutical manufacturing, distribution, or medical device companies.
* Excellent verbal and written English communication skills to motivate and support internal/external customers.
* Analytical, flexible, with strong people management skills.
* Ability to prioritize decisions with significant risk implications and recommend training opportunities.
* Flexible working hours required.
Location
Liscate (with transition to Casalpusterlengo by the end of the year).
Additional Skills
Knowledge of Microsoft Office, electronic Quality Management Systems, and Warehouse Management Systems (WMS, GWS) is advantageous.
Employee Type
Permanent
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