CLINICAL TRIAL PRODUCT RELEASE QA

POSITION SUMMARY:

To support clinical trial for biotech companies Pharma IT is searching for a Clinical Trial Product Release QA.

The Clinical Trial Product Release QA will provide manufacturing QA support in accordance with documented procedures and practices and be responsible for continuous reinforcement of established Quality Assurance fundamental practices and improvements if needed.

Furthermore the Clinical Trial Product Release QA will be:

  • Reviewing of production documentation and assisting with batch release procedures
  • Liaising with Operations personnel to ensure regulatory and quality requirements are met during routine operations
  • Supporting the ongoing deviation/corrective action program
  • Liaising with other departments to allow closure of corrective actions
  • Participating in audits and assisting with follow up
  • Responding to routine quality related queries from other departments
  • Monitoring and aiding the implementation of continuous improvements and process changes to ensure that these are implemented in compliance with GMP
  • Attending a number of cross functional team meetings / projects
  • Support the timely release of products
  • Conducting QA activities including revision of SOPs, QA work and the issuance of protocols
  • Review, approval and reporting activities related to the QMS

EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:

We are looking for a new colleague who has:

  • An education as pharmacist or equivalent
  • 5+ years of experience in a biotech, pharmaceutical or medical device industry
  • Experience with CA/PA systems, including complaint handling
  • A proactive and open-minded approach
  • Ability to work independently with personal drive
  • Emphatic and good social skills
  • A flexible and service minded approach
  • An eye for details and is comfortable working with high professional standards

PHARMA IT

Pharma IT consists of highly experienced people as well as young talents and we invite you to take a closer look at www.pharmait.dk

You will be added to our Drug Development Consulting Services team.

In Pharma IT we want to deliver price competitive, experienced and professional IT and business consultants to the pharmaceutical industry. We aim to cover IT Management, Program and Project Management, Drug Development Consulting, Test, Validation and Technical Consulting. We want to have an agile approach to the work we do for our customers to ensure that we constantly add value.

WE LOOK FORWARD TO YOUR APPLICATION

We encourage applications from people of all ages, genders, nationalities, religions and ethnic backgrounds.

Please send your application as soon as possible to Jakob Juul Rasmussen (info@pharmait.dk). Interviews will be performed on an ongoing basis.

Contact information: Please contact Jakob Juul Rasmussen (+45 2434 2655)