Description:
Our client, a global bio-pharmaceuticals manufacturing facility, is looking for a Qualified Person to join their fill/finish manufacturing facility!
Some of the key responsibilities for the Qualified Person will include:
- Participate in global Quality initiatives as a site subject matter expert
- Conduct activities of a Qualified Person as per Directive 2001/83/EC, Article 51
- Participate or lead projects and improvement efforts including product launches.
- Own, review and approve SOP's and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.
- Perform review and approval of validation documentation.
- Lead and participate in internal and external audits as needed.
Education & Knowledge:
- University Degree in a Science related discipline together with a post graduate course, which together with the primary qualification, satisfies the educational requirements as defined in Directive 2001/83/EC OR University Degree in Pharmacy
- Knowledge of the processes involved in Good Manufacturing Practice (GMP), warehousing, supply chain, equipment engineering principles and validation. Knowledge of applicable regulatory requirements