Description:

Your Job

Performing quality related tasks within GMP, GDP and ISO 9001 for PharmaLex clients

Providing specialist advice and guidance for our client’s pre- and post-marketing activities

Supporting maintenance of PharmaLex internal quality management system and supporting employees and the organization on quality related matters

Your Profile

You have a University degree in pharmacy or other natural sciences and at least 10 years of professional experience with quality related tasks within the pharmaceutical industry, including experience within several of the below areas:

Compliance according to GMP and GDP regulation;

Quality Management Systems;

Quality Oversight and Gap Analysis:

Qualified Person and/or Responsible Person;

Audits and Inspection;

Quality Agreements;

Project Management;

Deviations, CAPAs, complaints and recalls, root cause analysis, risk assessment;

Qualification and Validation, Tech Transfers;

API and/or Medicinal Product Manufacturing;

Supply Chain Management;

You have good communication skills, are structured and operate with integrity and professionalism. You are proactive and self-motivating with a can-do attitude.

You are an experienced user of the MS-Office package, Adobe Acrobat and database systems. In addition, you speak and write Danish and English fluently.

We offer

Opportunity to conquer exciting and varied challenges alongside an experienced and talented team in a dynamic company

External business interaction with clients and internal collaboration within the PharmaLex organization and within several areas of the pharmaceutical industry.

Broad range of initiatives for personal development and professional training

A friendly and openminded work environment in a global organization

Possibility to work from home