C&Q Engineer

☞ Adeodata

Aussicht: 138

Update Tag: 24-04-2024

Ort: Lugano Ticino TI

Kategorie: Apotheker / Pharmavertreter

Industrie:

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Jobinhalt

COSA PUOI TROVARE LAVORANDO IN ADEODATA?

>Formazione professionalizzante

>Budget per formazione linguistica

>Orari flessibili

>Ambiente giovane e collaborativo

>Possibilità di lavorare da remoto

>Rimborso del pranzo

On behalf of our client, one of the biggest biopharmaceutical

companies, we are looking for a

C&Q Engineer
Location: Bern (CHE, Switzerland) 1, Rehhagstrasse


DESCRIPTION

In charge of commissioning and qualification (C&Q) activities for Technical Services department in order

to ensure that:

1. Qualification/Validation phases are performed according to global and local company policies and

procedures as well as legal requirements and requirements set by regulatory authorities;

2. Qualification/Validation Master plans are up to date and established for all ongoing projects in QC

  • Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including

but not limited to, Qualification/Validation plans, FMEA, DQ, IQ, OQ, PQ.

  • Prepare, review and approve technical and GMP related documentation (URS, impact/risk

assessment, Master plans, qualification/validation documentation).

  • Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in

collaboration with internal and external partners.

  • Coordination and oversight of external suppliers.
  • Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification

topics.

  • THIS CONSULTANT WILL BE ESPECIALLY DEDICATED TO ACTIVITIES RELATED TO THERMAL

MAPPING AND AUTOCLAVES.


QUALIFICATIONS

  • Know-how of Commissioning and Qualification requirements according to cGMP regulations and

international guidelines;

  • Know-how of quality assurance principles and experience working with cross-department

stakeholders.


ADDITIONAL INFORMATION

Actual End Date:31/03/2022

Education Required:Bachelor/Master Degree in technical or natural sciences

A minimum of 3 years of working experience within pharma company in C&Q

Work Experience:equivalent position

  • Excellent communication skills
  • Analytical thinking and problem-solving ability

Non Technical Skills• Business fluency in English

and Additional• German language is a plus

Details:• Self time management

To apply, please write an e-mail to: candidature@adeodata.eu

www.adeodata.eu

Ufficio HR: candidature@adeodata.eu

Tel: +39 02 96720933

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Frist: 08-06-2024

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