Quality Assurance Professional (m/f)

full time - location Wien


Mehr Jobs von HR Consulting - Gerda Zeman
Kontakt: Gerda Zeman-Steyrer
Email: hrconsulting@gerdazeman.at

Quality Assurance Professional (m/f) – full time – location Vienna

Our client is an international late clinical-stage biotechnology company with expected application for US market approval in the second half of 2018. For the Vienna site we are looking for a Quality Assurance Professional (m/f) on full time basis. Our client´s main focus is on Research & Development of new chemical entities (NCEs) for human use to treat indications with high unmet medical need. The company is currently in the phase of changing into a commercial company. If you want to be part of this thrilling and at the same time challenging innovative world, here is what we offer.

 

Our offer

Highly responsible and diversified position in a well-established international biotech company

Innovative and professional work surrounding

Possibility for personal development and growth

Room to shape the next steps in the context of the company´s progress

Dynamic and flexible corporate culture

Familiar working atmosphere

Flexible working times

Competitive remuneration

 

Responsibilities

Accountability for designated quality assurance area(s)

Responsibility as main QA contact with designated vendors

Coordination and supervision of quality aspects with designated external contractors

Review and approval of quality and manufacturing documentation from vendors (e.g. deviations, changes, validation plans and reports, batch production records)

Close collaboration with internal CMC group to manage external manufacturing activities

Compilation of quality agreements with contract manufacturers and suppliers

Writing, review and approval of SOPs and other quality documentation

Review of protocols, reports and further documents intended for submission to regulatory authorities worldwide

Conduct of internal and external quality audits

Support of other departments in any quality related issues

 

Qualifications

University degree in Life Sciences (e.g. Pharmacy, Chemistry, Biotechnology, Microbiology) or University degree in Quality Management

Minimum of 5 years of experience in quality management in the pharmaceutical industry

Proven track record in dealing with quality related documentation

Thorough knowledge of GMP

Proven track record of quality oversight/management of GMP manufacturing activities

Experience in working with external contractors is of advantage

Experience with NDA/MAA submissions and with inspections is of advantage

First experience as an auditor is of advantage

Ability to work independently, to organize complex matters and to react flexible if needed

Passion for hands-on work within a fast-changing environment

Good sense for priorities

Pro-active approach and eagerness to shape the coming steps within QM

Willingness to quickly learn and take over responsibility step by step

Highly reliable and responsible personality

Passionate team player

Motivated and mature personality

Very good communication skills

Willingness to travel moderately (approx. every 2 months)

Good written and spoken command of English as well as German

 

The minimum salary for this position is € 50.000,-- gross per year but will be overpaid depending on the actual qualification of the candidate. We explicitly express our client´s willingness to offer a competitive salary in line with the market and considering your qualification, experience and individual competencies.

 

Does our description meet your expectations concerning your next career step? Then please send us your CV plus an informative motivation letter and convince us that you are the best candidate for this position. We are looking forward to receiving your application at hrconsulting@gerdazeman.at.


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