QA

3 weeks ago


At Gujarat, India ProData Consult Full time

Job Description : Support the overall design and implementation of CLINiC’s quality management system (QMS), leveraging existing QMS wherever possible. You will review and approve Standard Operating Procedures (SOP), as well as performing internal compliance audits, thanks to you understanding and following developments in GCP, Danish law and other regulations with interest.

Among your daily tasks, you will:

- Ensure a quality focused mindset, culture and suitable level of independence between Sponsor and CLINiC
- Take the lead on quality compliance and quality management review activities
- Support structured risk management activities
- Perform Investigator Trial Master File (ITMF) review and checks
- Provide training in relevant processes and legislation

**Qualifications**:
To succeed in this role, you can recognise yourself in the following:

- BSc or MSc degree with at least 3 years of experience within the field of GCP and clinical research, preferably with phase I
- Expertise with Danish and international quality governance is highly beneficial
- Expertise in applicable quality standards and pharmaceutical process and value chain understanding
- Expertise in the clinical trial process, requirements and methodology
- Fluency in written and spoken English and Danish
- Experience as in a process QA type role would be an advantage

As a person, you have a strong quality mindset. You have knowledge and understanding of relevant regulatory requirements and trends within the pharmaceutical business. Good communication and cooperation skills, including the ability to express ideas and knowledge effectively, is also a prerequisite.

Allocation : Onsite in Gentofte at least 3 days a week in agreement with Manager

Start Date 01/02/2023

End Date 31/07/2023


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