Symbiosis Expands Quality Leadership with New Qualified Person Appointment
Symbiosis Pharmaceutical Services (Symbiosis), a global contract manufacturing organisation (CMO) specialising in the sterile manufacture of injectable drug products, has appointed Wendy Cook as a Qualified Person (QP) to further strengthen its regulatory and quality leadership team.
Wendy brings more than 20 years of pharmaceutical quality
assurance experience across GLP, GCP and GMP environments, with experience in
sterile manufacturing and clinical trial supply chains. Since qualifying as a
QP in 2018, she has held roles at both CDMOs and global CMOs, where she oversaw
batch certification, regulatory submissions and quality oversight across
multiple dosage forms including sterile injectables.
Commenting on her appointment, Wendy said:
“Symbiosis has built a reputation for excellence in sterile manufacturing
and regulatory compliance. I look forward to supporting clients in bringing
their innovative therapies to patients quickly, safely and in full compliance
with GMP.”
The appointment follows Symbiosis’ successful MHRA
inspection of its new 20,000 sq ft GMP facility, which recently added a
state-of-the-art automated sterile fill/finish line to the company’s commercial
capabilities. This latest regulatory milestone reinforces Symbiosis’ robust
compliance track record with both the MHRA and FDA.
Nicola Paterson, Lead QP at Symbiosis, said:
“Wendy’s appointment strengthens our QP team at a pivotal time for
Symbiosis. Her knowledge of GMP, regulatory expectations and sterile
manufacturing adds significant expertise to our quality leadership. Combined
with our recent regulatory approvals, Wendy’s
arrival underlines our commitment to delivering world-class regulatory support
and compliant, flexible access to sterile manufacturing capacity for our
clients
By expanding its QP
and quality leadership team, Symbiosis continues to enhance its ability to help
global biopharmaceutical companies navigate complex regulatory requirements
while ensuring the reliable, timely delivery of life-saving injectable
therapies.