Qualification Expert (f/m/d) Bucharest

Qualification Expert (f/m/d)
Bucureşti
Bucharest, Bucharest, Romania

Qualification Expert (f/m/d) - COMOS/EVAL/GMP/validation/Pharma

Project:

For our customer a big pharmaceutical company in Kaiseraugst we are looking for a highly qualified Qualification Expert

Background and perfect candidate:

The support function ES&T (Engineering, Science and Technology) supports the value streams (production) with its technical expertise and ensures the regulatory requirements for our products over the entire life cycle. This is achieved through maintenance, validation and harmonization of processes (asset life cycle).



The perfect candidate is an experienced qualification expert with several years of
- on experience in qualification within a GMP environment, preferably the pharmaceutical industry.



Tasks & Responsibilities :

. Responsible for planning and conducting qualification and validation activities

. Creating and reviewing qualification and validation documents

. Producing SOPs and providing support in the creation of manufacturing specifications

. Responsible for maintaining the qualified and validated status of rooms, infrastructure and equipment

. Ensuring compliance with internal and external regulatory requirements with regard to qualification and validation

. Collaborating closely and communicating intensively with other departments

. Providing assistance in the processing of deviations, changes and CAPAs



Must Haves:

. Technical degree in a relevant field

. Further training and
- on experience in the area of GMP

. Min. 3-5 years of experience in the qualification and validation of machines and processes, preferably in the pharmaceutical industry

. Several years hands on work experience in qualification

. Experience with Siemens COMOS, EVAL and VIVA

. Fluency in German spoken and written needed, English fluency written and reading comprehension

. Very independent and structured way of working with a
- image of self and to continuously improve the processes

. High degree of initiative, flexibility and quick comprehension skills

. Enthusiasm for working together in
- organized teams and for your own areas of responsibility areas of responsibility with a focus on the big picture

Reference Nr. : SGR

Role: Qualification Expert

Industry: Pharma

Workplace: Kaiseraugst

Pensum: %

Start: ASAP

Duration: 12

Deadline : 19. 11.

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

About us :

ITech Consult is an ISO : certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.