Corden Pharma is an expert Contract Manufacturing partner, enabling pharmaceutical and biotechnology companies to link their requirements for product success with their patients’ healthier lives. Formed as a pharmaceutical branch of International Chemical Investors Group (ICIG) in 2006, Corden Pharma provides specialized technologies, grouped under six technology platforms that are ideal for the development and manufacturing of oral, sterile, highly potent and antibiotic pharmaceutical Drug Products, their Active Pharmaceutical Ingredients, and associated Global Supply Chain and Packaging Services. As a full-Service CDMO for the global market, Corden Pharma is committed to bringing inspired global service and flexible solutions, spanning the entire pharmaceutical product continuum. The company’s chemists and engineers are widely recognized for their history of innovation, having developed highly efficient manufacturing processes for some of the world's most complex pharmaceutical compounds.
With multiple cGMP compliant facilities across Europe and the United States, Corden Pharma is the flexible, efficient, and cost-effective solution for all contract manufacturing needs.
International Chemical Investors Group is a privately owned industrial holding company founded in 2004 which focuses exclusively on acquisitions of mid-sized chemical and pharmaceutical businesses, preferably subsidiaries of large corporations operating in competitive environments which were considered non-core. All companies owned by ICIG have origins in major global chemical or pharmaceutical corporations and are independently managed. ICIG values the legacy of capable employees formed from each facility’s respective areas of scientific, operational, R&D and sales expertise.
For our German locations in Frankfurt we are looking for a qualified
Corporate QA Systems Manager (f/m) Frankfurt
In Liaison with the Global Head QA/RA/HSE Compliance and the respective site Quality responsible to ensure that requirements of the Corden Pharma Quality Systems are correctly implemented and continuously improved.
- Organizing, coordinating and conducting of group wide GMP training requirements in aseptic, terminal sterilization and non- aseptic operations for Finish Drug Products and APIs
- Review, coordination and preparation of technical agreements between corden sites and external business partners as well as among corden sites in accordance with CGMP guide lines and the corden corporate standards.
- Ensuring external inspection and internal audit readiness through assistance in preparation, during the audit / inspection (as agreed with the site) and development and follow-up on the CAPA.; preparation, support and attendance in regulatory agency inspections and conducting of corporate audits as well as external supplier audits
- Coordination of implementation of Corporate Compliance Policies und Standards including QA oversight of Lab systems and ensuring lead in specific Quality topics, as agreed with the Global Head QA/RA/HSE Compliance
- GMP support of all new and ongoing multi sites and or single site projects proactively identifying potential issues and compliance gaps. Contact person for Global Marketing and Sales team for all GMP queries from business partners and potential ones.
Experience and skills:
- Experience and education in natural science or technical fields with a minimum of 10 years of professional experience in the field of QA and/ or QC; experienced in SAP, LIMS and TrackWise applications
- Broad knowledge in GMP Quality requirements and profound experience in participating in FDA and GMP- inspections.
- Act as a strong team player for computerized system validation within an international team, develop efficient and structured ways of working to drive project results; striving for results through taking ownership andbeing solution focused and achievement-orientated
- Excellent communication (both written and oral) skills in German and English, further language(s) a plus; willingness to travel on a regular basis
- A position offering the potential to make the next step within ICIG
- Sole responsibility for a variety of challanging tasks offering a large degree of freedom to make decisions in a straightforward and a strong team oriented culture
- Flat hierarchies with short communication and decision paths in the very agile environment of an internationally operating group of companies
If you are seeking a new challenge in an international and dynamic environment, please send your CV including references and cover letter as well as your salary expectations and earliest availability. Please send your application preferably through the application link in the job advertisement.
Corden Pharma GmbH