Arbetsbeskrivning

Technogarden Life Science has extensive experience from the pharmaceutical industry, scientific research, biotechnology, medical technology, and food production. We always work according to the latest standards and regulations, and with great personal commitment.

In order to support our clients in the best possible way, we offer both consultants and recruitment in Life Science and MedTech. Thus, we can provide guidance, training, and seminars about the latest regulations. We are attentive to the world around us and knowledge transfer is an important part of every successful recruitment or consulting job.

We at Technogarden are currently looking for a colleague in our Life Science team who bring a couple of years experience as a Quality Assurance Specialist within the Pharmaceutical Industry. The assignment is at one of our clients who would like you to start asap with a minimum duration of one year.  

Responsibilities

Your responsibility at our Client is to coordinate Quality Activities within GDP with Quality Manager GDP. You will interact with subsidiaries and external counterparts at PWS and CMOs, review GDP documents from pre-wholesale/wholesaler/transporter and for controlled medicinal product:

• Quality Agreements
• Change Controls, Deviations and CAPAs

Further you should handle complaints and alerts from serialization system for medicinal products. You are also responsible for the preparation of documents for PQR. Further tasks:

• Establish and evaluate Vendor Questionnaire (GDP)
• Review, write, approve and implement SOPs within GDP and if applicable Pharma
• Participate in vendor and customer qualification
• Participate in quality risk management procedures for GDP

Qualifications

Educational

Academic degree within life science/engineering or pharmacy

Professional experience

Minimum 5 years within pharmaceutical industry or Quality Assurance

Technical/functional area skills

Beneficial with knowledge of applicable international standards and guidelines for Pharmaceuticals within GDP in EU and in national legislation as applicable.

Beneficial with experience of complaint, and deviation and change management

Your personality

We think (and like) that you have a positive mindset and a can-do attitude. You bring experience from previous QA rolls and can take decision based on facts, legislation and circumstance. As a person you are structured, systematic, efficient and you have an organized way of working.  You have excellent communication skills. 

Languages

You are fluent in written and spoken Swedish and English. 

Systems (IT)

Experienced user of MS Office package

Here at Technogarden you will be part of a really nice team of different professions within Life Science and Engineering but also a valuable and appreciated colleague at our Clients. The best of both worlds! We need your application asap. Please don´t hesitate to call or mail if you have any questions. Welcome!