QA Manager (m/f/d)

QA Manager (m/f/d) – GMP / CAPA / IMPQ CH / SAP / German and English

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified QA Manager (m/f/d).

Background:
The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality, Quality Systems and GMP-compliance oversight of all Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland.
You support the end to end Quality Systems activities including IT systems maintaining the Right to Operate at the Swiss Technical R&D sites and in ensuring quality and compliance of IMP products according to Health Authority requirements and Company Standards for IMP products. You also Support Business Process Management of the Release Quality System CLARA with special emphasis on batch tracing activities.

The perfect candidate:

Sound knowledge and experience in the area of quality systems as well as knowledge/faible for IT Systems. CSV knowledge is an additional plus.

Tasks & Responsibilities:

• Running, maintaining and continuously improving the Quality Systems business processes (Focus: Discrepancy Management, CAPA, Technical Change Management)
  * Support the business process of the Release Quality System CLARA with special emphasis on batch tracing activities
  * Partner with IT, other quality functions and supply chain in projects regarding introduction of new IT Systems. Representation of the IMPQ CH in cross functional teams
  * Openness for other quality related activities within IMPQ CH

Must Haves:

• Min. Bachelor’s Degree in Chemistry, Life Science, Engineering, Pharmacy, IT or equivalent
  * Min. 3 years of experience in a GMP regulated environment
  * Min. 1 year experience with SAP
  * First experience with Quality Systems, Quality assurance or OT (Discrepancy Management, CAPA, Technical Change Management)
  * Fluent in both German and English
  * Fast learner, strong team-player with a high level of self-motivation and with ability to prioritize, simplify and connect the dots
  * Proven ability to work towards results, excellent planning and organizing skills in order to manage multiple tasks at the same time as well as analytical capabilities and an innovative manner of solving problems

Nice to have:

• Project management skills
  * Experience in Pharmaceutical Industry
  * Performance in health authority inspections and internal GMP audits

Reference Nr.: 922795SGR
Role: QA Manager (m/f/d)
Industrie: Pharma
Workplace: Basel
Pensum: 100%

Start: 01.10.2023
Duration: 12++
Deadline: 07.08.2023

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.