Description
My client is an FDA / EU-GMP certified contract manufacturer in the pharmaceutical sector (ophthalmic) and part of the US-based Group. At the site near Winterthur area, high-quality sterile products such as eye drops, ointments and gels are aseptically produced, bottled and packaged for international markets. For them I am actively looking for a:QC Leader 100% m/f
Responsibilities:
- Lead the chemical-physical department at the site with the overall responsibility of the professional assessment for the analytical release of pharmaceutical semi-finished and finished products.
- Responsible for Raw Material Release, Finished Products Release, Validation / Product Transfer, QC-support (Stability and Packaging Release) and 1 Coordinator for analytical product transfers.
- Responsible for the analytical release of raw materials, stability samples and finished products
- Professional assessment and root cause analysis of analytical deviation reports, OOS examinations and the definition of corrective and preventive measures
- Professional support in making changes, especially risk assessments
- Ensuring the calibration, maintenance and qualification of analytical equipment
- Professional and personnel overview of method transfer and validation activities
- Knowledge of the most important pharmacopoeia book methods (Ph.EUR / USP / BP) and compliance with the most important regulatory requirements in the GMP environment
- Support of customer projects in the analytical field
- Ensuring the timely release of raw materials and finished products
- Interdisciplinary cooperation with internal and external customers
- Support for regulatory inspections and audits
- Professional support of the HSE team
- Participation in laboratory optimization projects (Laboratory Excellence)
Requirements:
- At least 10 years experience in pharmaceutical quality control
- Science degree (FH, Uni, ETH)
- Knowledge of instrumental and classical chemical analysis
- Sound GMP knowledge (EU, FDA), as well as ISO and ICH guidelines
- Proficient in German and English
- Knowledge of IT systems in the pharmaceutical environment
Extra Information:
- Beginning: latest beginning of February 2018
- Permanent position
- Utilization: 100% on site
- Location: Winterthur,Switzerland
- Language: English and German fluent
About me:
I am a specialised recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in word format
You can reach me on or at
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.