Overview
We are currently looking for an IMP Quality Manager. In this role, you will ensure the compliance and continuous improvement of GMP standards across all IMP production facilities. The Synthetic Molecules IMP Quality Group is specifically responsible for quality oversight of the Synthetic Molecules Drug Substance and Drug Product operations, as well as the associated QC control.
Key Responsibilities
* Document Review and Approval: Conduct thorough reviews and approvals of analytical methods, method validations, specifications, risk assessments, deviation reports, investigations, change control records, and stability reports to ensure compliance with GMP standards.
* Quality Agreements: Develop and maintain product-related quality agreements to ensure clear and consistent quality expectations and standards.
* GMP Support: Provide expert support to departments on GMP-related issues, offering guidance and solutions to ensure compliance and continuous improvement.
* Self-Inspections: Plan and execute self-inspections to identify areas for improvement and ensure adherence to GMP standards.
* Quality Oversight: Monitor and oversee the quality control processes for Synthetic Molecules Drug Substance and Drug Product operations, ensuring all activities meet regulatory requirements.
* Training and Development: Facilitate training sessions and workshops for staff to enhance their understanding of GMP requirements and quality standards.
* Risk Management: Identify and assess potential risks in production and packaging processes, implementing strategies to mitigate these risks.
* Continuous Improvement: Drive initiatives for continuous improvement in quality processes, leveraging data and feedback to enhance overall quality performance.
Must-Haves
* Completed scientific degree.
* At least 5 years of experience in the pharmaceutical industry.
* Ideally, professional experience in pharmaceutical development (Synthetic Molecules, Quality Control, or Quality Assurance).
* Knowledge of cGMP and quality requirements, ideally for clinical development phases.
* Good IT skills (MS Office) - especially experience with SAP and other quality management systems (e.g., Veeva).
* Excellent communication and teamwork skills.
* Independent working style, high quality awareness.
* Fluent in German and English, both written and spoken.
If you feel confident about this opportunity, we encourage you to apply, or to reach out to me via email at mbertrand@actalentservices.com.
Job Title: IMP Quality Manager
Location: Basel, Switzerland
Job Type: Contract
Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.
To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.
We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield
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