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SII Sp. z o.o.

Validation Expert

SII Sp. z o.o.O firmie

  • Gdańsk, pomorskie

  • Ogłoszenie wygasło 5 dni temu
  • Specjalista
Validation Expert
Location: Gdańsk
The challenges waiting for you:

Testing Services Competency Center at SII - who are we?

Maybe you have heard that we are the biggest test center in Poland.  But did you know that we…

  • are recognized by the British Testing Magazine and ComputerWorld as a top testing service provider?
  • have over 200 local and international clients?
  • are currently completing more than 300 projects?

 

Right now we are looking for somebody who will be responsible for validation on multiple levels (documentation, equipment involved in ensuring quality of produced medicines and a variety of IT systems) for one of our clients from the pharmaceutical industry and would ensure that all requirements and regulations are followed.

 

Essential responsibilities:

  • Preparing validation documentation (CSV) – reports from test validation, risk analysis
  • Supporting the creation of testing documentation
  • Taking part in introducing new and maintaining existing CSV policies
  • Leading CSV consultations within company
  • Ensuring that all IT systems are up and running and ready for possible audits (for example – FDA, EMA)
  • Identifying and implementing appropriate and effective corrective/preventative actions (CAPA)
  • Supporting projects related to implementation of new IT systems (SCADA, MES, LIMS, ITSM, ERP systems…)
Required skills:

  • 3+ years of experience in a similar position or one connected to software testing/pharmaceutical manufacturing
  • Fluency in English
  • Experience in CSV/GxP
  • Experience with audits (FDE, EMA)
  • Knowledge or experience related to the pharmaceutical industry (e.g GAMP5, Annex11, CFR21)
  • Experience with a variety of IT systems would be a plus (SCADA, MES, LIMS, ITSM, ERP)
  • Laboratory skills or knowledge regarding laboratory equipment would be a plus
Your benefits:

  • You will join the Leader. With over 4 000 specialists, Sii is actually the fastest growing, most successful & undisputed number 1 IT & Engineering services company in Poland!
  • You will work on challenging & fascinating international projects run for hundreds of prestigious customers from various sectors & industries
  • We will guarantee you many career development opportunities, facilitated by our Job changer application which allows you to change a project, the area of your activity or a place of work
  • You will cooperate with the best experts in talented & passionate teams on most advanced cutting-edge technologies
  • You will work in Great Place to Work company with amazing atmosphere and authentic values. You will meet new fantastic friends here!
  • We will support your personal dreams and initiatives within Passion Sponsorship Program and Power Volunteers Program
  • We will invite you to awesome integration meetings, interest groups and meetups
  • You will enjoy comfortable, top class, modernly designed offices in the best locations
Are you interested in this offer?
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Remember to attach the following personal data processing consent:

„I hereby grant consent for the processing of my personal data contained in this CV by Sii sp. z o.o. with its registered office at Al. Niepodległości 69, 02-626 Warsaw (“Sii”) for the purposes of recruitment carried out by Sii. At any time, you may withdraw your consent for processing, but such withdrawal shall not affect the legal compliance of any processing which occurred before you withdrew your consent. Sii does not make any automated decisions regarding the processing of personal data in recruitment process. Detailed information on the processing of your personal data is specified in the Privacy Policy.”

Please note that we will contact only selected candidates.
Validation ExpertNumer ref.: 200115-KXBCY

Testing Services Competency Center at SII - who are we?

Maybe you have heard that we are the biggest test center in Poland.  But did you know that we…

  • are recognized by the British Testing Magazine and ComputerWorld as a top testing service provider?
  • have over 200 local and international clients?
  • are currently completing more than 300 projects?

 

Right now we are looking for somebody who will be responsible for validation on multiple levels (documentation, equipment involved in ensuring quality of produced medicines and a variety of IT systems) for one of our clients from the pharmaceutical industry and would ensure that all requirements and regulations are followed.

 

Essential responsibilities:

  • Preparing validation documentation (CSV) – reports from test validation, risk analysis
  • Supporting the creation of testing documentation
  • Taking part in introducing new and maintaining existing CSV policies
  • Leading CSV consultations within company
  • Ensuring that all IT systems are up and running and ready for possible audits (for example – FDA, EMA)
  • Identifying and implementing appropriate and effective corrective/preventative actions (CAPA)
  • Supporting projects related to implementation of new IT systems (SCADA, MES, LIMS, ITSM, ERP systems…)

  • 3+ years of experience in a similar position or one connected to software testing/pharmaceutical manufacturing
  • Fluency in English
  • Experience in CSV/GxP
  • Experience with audits (FDE, EMA)
  • Knowledge or experience related to the pharmaceutical industry (e.g GAMP5, Annex11, CFR21)
  • Experience with a variety of IT systems would be a plus (SCADA, MES, LIMS, ITSM, ERP)
  • Laboratory skills or knowledge regarding laboratory equipment would be a plus

  • You will join the Leader. With over 4 000 specialists, Sii is actually the fastest growing, most successful & undisputed number 1 IT & Engineering services company in Poland!
  • You will work on challenging & fascinating international projects run for hundreds of prestigious customers from various sectors & industries
  • We will guarantee you many career development opportunities, facilitated by our Job changer application which allows you to change a project, the area of your activity or a place of work
  • You will cooperate with the best experts in talented & passionate teams on most advanced cutting-edge technologies
  • You will work in Great Place to Work company with amazing atmosphere and authentic values. You will meet new fantastic friends here!
  • We will support your personal dreams and initiatives within Passion Sponsorship Program and Power Volunteers Program
  • We will invite you to awesome integration meetings, interest groups and meetups
  • You will enjoy comfortable, top class, modernly designed offices in the best locations

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