will be responsible, with management support, for providing oversight of
quality activities associated with drug product manufacturing processes to
contract manufacturing organisations.
· The Specialist contributes and guides completion
of milestones associated with specific projects and supports ongoing quality
assurance responsibilities in support of: Contract Manufacturing oversight and
quality systems including Change Control, Deviations, and CAPAs.
· Performs all responsibilities in accordance with
company policies, procedures, and federal regulations.
· The incumbent will be responsible for supporting
drug product manufacturing and assessing the compliance of this program against
best industry practice and current regulatory expectations.
· Validation experience (Must have)
· Excellent accuracy and attention to detail
· Planning and organizing skills are required to
plan, execute and track commitments of Quality Assurance and to adjust to
science/pharmacy or relevant experience in regulated GMP industry