Corden Pharma International GmbH
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
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 IT Compliance Manager (f/m)
- >> Assure compliance of Corden Pharma Corporate Quality System regarding Data Integrity with current guidelines, computerized systems validation with current guidelines as well as that those are deployed in a compliant manner in accordance with the Corden Pharma Corporate Quality System
- >> Ensuring that the sites’ Quality units are adequately trained in the respective Corden Pharma Corporate Quality System modules and Regulatory requirements for computerized system validation and providing/organizing appropriate training on site if needed
- >> Organization of Quality networks for computerized system validation to assist in sharing of information, identification of best practices and actions on continuous improvement and providing support to the sites during implementation of corporate or local computerized systems to comply with Corden Pharma Corporate Quality System
- >> Establish and define standard computerized systems to use/implement in all Corden Pharma sites together with the sites (e.g. SAP, LIMS, CDS, DMS, Training System, Deviation-OOS-Change Control-Complaint-CAPA System)
- >> 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 with regards to computerized systems and Data Integrity and conducting internal audits of sites and follow up on CAPAs with regards to computerized systems and Data Integrity
EXPERIENCE & SKILLS
- >> Experience and education in natural science or computer science with a minimum of 10 years of professional experience in the field of IT and/ or compliance;
- >> Broad knowledge and and in depth expertise as well as experience in computer system validation and respective requirements/guidelines (21 CFR Part 11, Annex 11, GAMP); Knowledge in SAP, LIMS, 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.