Description
Responsibilities include:- Implement the companies' supplier quality program (audit, qualification, monitoring) for suppliers to ensure approved suppliers are capable of meeting and regulatory requirements for materials management, GMP production, testing, packaging, release, stability, and distribution of product
- Lead and participate in external audits.
- Person-in-Plant (PIP) at CMO drug manufacturing and packaging site.
- Review batch production records and analytical data for release & stability studies of products from CMOs & CLOs.
Experience Required:
- 5+ years working in Quality Assurance for an FDA regulated Pharmaceutical or Biotech company.
- Highly extensive knowledge of cGMP standards and quality systems.
- Must posses Quality management and leadership skills.
- 20-30% travel required
- ASQ auditing certification (Added Bonus)
If you believe that you have the required experience and can fulfill these responsibilities, please apply and I will reach out to you shortly.
To find out more about Real please visit www.realstaffing.com