QRM Data Verification Quality Manager (f/m/d)

QRM Data Verification Quality Manager (f/m/d) – pharma /packaging / data / German / PQS

Project:
For our customer a big pharmaceutical company in Kaiseraugst we are looking for a highly qualified QRM Data Verification Quality Manager

Background:
Quality Risk Management records are migrated from a legacy system to a new system. The migration is quite challenging and requires a 100% manual check of the migrated data including potential correction, also known as data verification. Further the risk records need to be updated according to the project plan to reflect the current situation. Aim of this position is to perform the verification and correction of the migrated risk records in the new system in collaboration with quality management and other functions as required and to perform updates of the risk records. All tasks are conducted with close contact to Data Verification Assistance, QRM Owner and other stakeholders.

The perfect candidate:
The perfect candidate has experience as Quality Assurance Manager in a pharmaceutical company. E.g. in the field of packaging, sterile filling and/or solid DS/DP manufacturing. She/He has first experience in data verification or data handling and knows how to work in an GMP regulated environment and has a sound knowledge of risk management. The candidate needs to have a rapid grasp regarding new IT systems and a firm understanding which impact GMP documentation makes.
In this position the candidate proceeds the required approvals with a sound knowledge of regulatory requirements as well as internal Pharma Quality Standards (PQS) and ensures compliance of these

Tasks & Responsibilities:

• Data Verification between legacy system and new One QMS (Veeva QRM)
  * Approvals of documents in consideration of regulatory requirements as well as internal Pharma Quality Standards (PQS) and ensuring the compliance of these.
  * Close communication with risk record owner, SMEs and other stakeholders
  * QA-Approval of verified and/or updated risk records as Quality Assurance
  * Ensure compliance of approved records with internal and external standards and specification
  * QA-role as well as owner role für unplanned events

  Must Haves:

• Technical or university degree (Masters degree ongoing is an option)
  * Min. 1-3 years experience as QA Manager in pharmaceutical industry
  * Min. first experience in data verification or data handling
  * First experience in Risk Management
  * Common office software (e.g. Google, Microsoft), good understanding of Excel/GSheet, database handling
  * Fluent in German, English min. B2
  * Accurate and solution-oriented working, teamplayer

Reference Nr.: 922619SGR
Role: QRM Data Verification Quality Manager
Industry: Pharma
Workplace: Kaiseraugst
Pensum: 100%
Start: 01.06.2023
Duration: 9++

Deadline: 12.05.2023

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.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 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.