quality assurance officer in Bern

posted
contact
Olivier Worch, Basel Professionals Health Care & Life Sciences
job type
temporary
apply now

job details

posted
location
bern
sector
Life Sciences
job type
temporary
reference number
11948
contact
olivier worch, basel professionals health care & life sciences
phone
058 201 55 50
apply now

job description

Randstad Professionals is currently looking for a Quality Assurance Officer (New Product Introduction)  who will be assigned an interesting challenge for a major client based in Bern.

This contract is a great opportunity to join a major client, global group focusing on the Healthcare sector  (Medical device, Pharma/vaccines, Consumer health).

The initial assignment will start January 2019 and will last until December 2019  

The Quality Assurance Officer works in a dynamic environment, where he/she should be able to make sound judgments based on quality principles and to provide compliant solutions to problems. The job holder should be an independent person and should be able to work constructively and negotiate with various parties throughout the organization, like Contract manufacturers, Process Development, Warehousing, Manufacturing, and Assay Development.

 

The roles offer the opportunity to work with ground-breaking products and manufacturing technologies, be involved with cutting edge science and develop new quality approaches. The activities within the two QA groups are similar, with Drug Substance QA focused on the in-house and contracted manufacturing of bulk vaccines and antibodies, and the Drug Product QA focused on the contracted manufacturing of finished products for use in Clinical Trials.

Your tasks:

- Carry out all QA duties related to the manufacturing of innovative vaccine products and monoclonal antibodies

- Advising and guiding product development teams

- Review and approval of stability documentation

- Working with and maintaining oversight over contract manufacturers

- Reviewing deviations, CAPAs and changes from contract manufacturers and in-house GMP departments

- Auditing contract manufacturers

- Ensuring batches are ready for QP release

- Keep procedures related to QA activities up-to-date, identify and implement improvements

 

Qualifications:

- University level in life science

- At least 5 years working experience in QA

- Preferably knowledge of vaccines and/or recombinant proteins.

- Good written and spoken English language skills. German is an advantage

- CAPA: 5 years

- GMP:  5 years

- Non conformance records:

- NPI (new product introduction): 5 years

- Root cause Analysis: 3 years

 

If you are interested to learn more about this role, don't hesitate to get in touch with me. 

You can also reach me under 0041 58 201 55 55 if you want to het more details about this great contract. 

I am looking forward to receiving your application!

 

Olivier Worch

Randstad Professionals Basel

olivier.worch@randstad.ch