Technical Distribution Associate
6 meses atrás
Linde Portugal, LDA
**Technical Distribution Associate (M/F/d)**
Lisboa, Porto, Portugal | req16023
**What you will enjoy doing**
- Furthermore be responsible for QMS, GMP, GDP and Medical Devices training to all personnel involved in medicinal product and medical devices activities
- You will cooperate in any decision to quarantine or dispose of returned, rejected, recalled or falsified products;
Evaluate the impact of any change that could impact the QMS, GMP, GDP or Medical Devices
- You should be responsible for the process monitoring and prepare Quality Control Reports and Product Quality Reviews (PQR)
- Will be part of your tasks the Equipment Qualification and Process Validation, Protocols, Risk Analysis and Validation Reports
- You must ensure that internal and external audits (in the scope of QMS, GMP, GDP and Medical Devices manufacturing and Distribution Devices are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
- You will have responsibility of ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
- You must ensure that corrective/preventive actions, consequence of deviations, non-conformities, recalls, out of specification results, complains, pharmacovigilance, audits or inspections, are fulfilled and registered in conformity with QMS, GMP, GDP and Medical Devices compliance monitoring and follow up the entire recall process by making all the records and preparing a final report of the whole process
- You will support in Marketing Authorization process maintenance and ensure regulatory compliance with regards to medicinal products, medical installations and authorizations and be the contact person with National Health Authority
- You must monitor applicable legislation and assess the impact of changes, implementing any actions that are identified as necessary to ensure regulatory compliance
- Additionally act as Local Vigilance Officer following local vigilance regulations and implementing global vigilance standards
**What makes you great**
- You have a degree in Pharmaceutical Sciences
- You have at least 2 years of experience in similar roles
- You speak Portuguese and English fluently
- You have experience in dealing with competent authorities
- You posses a high degree of self-motivation and self-responsibility
- You are communicative, emphatic, proactive and team player
**Why you will love working with us**
At Linde we identify ourselves with our products - either working for the technical or medical gases business. Being a company with a long tradition in the gases business, we not only care about our customers and high quality products, but most importantly about our employees. While working with us, expect a safe workplace, high safety standards and a true commitment from our managers to safety.
**What we offer you**
At Linde, the sky is not the limit. If you’re looking to build a career where your work reaches beyond your job description and betters the people with whom you work, the communities we serve, and the world in which we all live, at Linde, your opportunities are limitless. Be Linde. Be Limitless.
**This role is a full time position based on an unlimited contract. The standard weekly working hours will be from 08:30 hrs till 17:30 hrs.**
**Have we inspired you? Let´s talk about it**
Linde acts responsibly towards its shareholders, business partners, employees, society and the environment in every one of its business areas, regions and locations across the globe. The company is committed to technologies and products that unite the goals of customer value and sustainable development.
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