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08.04.2021
★★★ CSV Specialist, PharmaLex Bulgaria JSC  Вижте визитка на компанията
Месторабота София; Постоянна работа; Пълно работно време
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CSV Specialist

Be a part of our growing company!

Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? Then make PharmaLex your career choice! PharmaLex is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting. We are specialized in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance activities. The success of our company resides in the expert knowledge and high motivation of our employees.

We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment. So, if your career is much more than just a job for you but rather your passion, then come and join our successful team. In Sofia we are looking for a CSV Specialist.

Your Functions:
► Gain sufficient knowledge of the local CSV procedures;

► Provide support with qualification of infrastructure
• Follow up of the deliverables for Operational Phase such as Change Control, Incidents (IT), Configuration Management (Make sure that all documents are signed by the required people and filed in the proper location);
• Perform Qualification (IQ/OQ of Qualified Statistical SW);
• Internal Audit for infrastructure.

► Support the validation of custom software (GAMP 5 category 5).
• Establish the list of deliverables (quality), help in completing URS with regards the regulations, help in the set up of the Risk Matrix, update the requirement tracevaility Matrix;

► Assist in performing GAP analysis on current status versus regulation requirements (such as Electronic Signature solution implementation);

► Review and approve IQ and OQ protocols & reports, PQ protocols & reports;

► Write, review and approve validation plans and validation summary reports;

► Support the process of validation of statistical projects;

► Assist with (automated) testing of custom build software;

► Review of CSV specific SOP’s and Templates


Your Profile:
► At least 1 year experience (ideal 3 years) in a computer systems validation role in the pharma sector;

► Knowledge of specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11);

► Autonomous working manner

► Ability to deliver high quality documentation work;

► Good document management skills because most work will be documentation-based (administrative assistant);

► Fluency in English.

Our offer:

► Opportunity to conquier exciting and varied challenges alongside a talented team;

► Option for flexible working hours;

► Open and collaborative organisational culture with emphasis on knowledge-sharing;

► Business interaction with nearly all branches of the company across 5 continents;

► Broad range of initiatives for personal development and professional training.

If you are interested to take up the challenge at our future-oriented company, and would like to grow together with us, apply by sending your CV and Cover Letter (optional). We appreciate all applications but will be able to contact only the short-listed candidates. Thank you!


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