Description
This position is with a very exciting company in the East Bay that just received approval for their second drug. They currently have one commercial product that is manufactured in Europe and are looking fo a new CMO inside the US to manufacture their newest product. All of this requires an experienced proffesional to come in and oversee all of the CMO operations. Some of the responsibilities and requirements for this position are as follows:- Implement the supplier quality program (audit, qualification, monitoring) for suppliers to ensure approved suppliers are capable of meeting the companies and regulatory requirements for materials management, GMP production, testing, packaging, release, stability, and distribution.
- Oversee supplier activities and perform routine supplier document review/approval as required to ensure ongoing compliance with all applicable specifications, procedures, standards, regulations, and submission requirements
- Review executed batch records and perform final batch disposition
- Quality representative for internal investigations related to product compliance. Includes oversight and evaluation of discrepancies and CAPAs.
To find out more about Real please visit www.realstaffing.com