Quality Assurance Manager (m/f/d) Bucharest

Quality Assurance Manager (m/f/d)
Bucureşti
Bucharest, Bucharest, Romania

Quality Assurance Manager (m/f/d) - GMP / CAPA / Pharma/ German / English

Project:

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

Background:

As part of the Quality Unit
- site, the team QA Facility & Engineering ensures GMP compliance of all production facilities at the Basel Drug Substance Manufacturing site. The team's responsibilities include the quality oversight of the qualification status of all production equipment, automation systems, laboratory equipment, the building infrastructure, and the utilities of all four production areas
- site (large-scale production of monoclonal antibodies;
- scale
- use technology for production of monoclonal antibodies; production of
- drug conjugates; production of synthetic molecules active substances).

The perfect candidate:

The perfect candidate has an university degree in science or engineering and several years of demonstrated experience in Quality Assurance at a pharmaceutical manufacturing site. Practical experience in commissioning & qualification projects in highly automated GMP production facilities is required and the candidate needs to have well established confidence in setting precise guidance for QA compliance in technical changes, deviations and CAPAs. Since the documentation is in German, the candidate needs to be fluent in both English and German.



Tasks & Responsibilities:

. You have
-
- end quality oversight on the qualified state of all assets in your assigned area.

. You provide fit for purpose quality support for all the activities related to qualification & CSV, calibration, maintenance & reliability engineering.

. You review and approve GMP records that cover technical change management, deviation management & CAPAs, risk assessments and SOPs.

. You coordinate and facilitate complex investigations, root cause analyses, technical risk assessments, and continuous improvement projects.

. With your operations partner you present topics during health authority inspections and internal audits.

Must Haves:

. University degree in science or engineering

. Min. 3 years demonstrated experience in Quality Assurance at a pharmaceutical manufacturing site

. Practical experience in commissioning & qualification projects in highly automated GMP production facilities

. Well established confidence in setting precise guidance for QA compliance in technical changes, deviations and CAPAs

. Your collaboration with partners is characterized by outstanding communication and team work.

. You manage to drive quality awareness with operations partners at all levels by integrating regulatory requirements, analytical problem solving and scientific rationale.

. Excellent German and English language skills, both written and spoken.

Reference Nr. : TP

Role: Quality Assurance Manager (m/f/d)

Industrie: Pharma

Workplace: Basel

Pensum: 80 - %

Start: 01. 01.

Duration: 36

Deadline : 14. 11.

If you are interested in this position, please send us your complete dossier.

About us :

ITech Consult is an ISO : 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.