Melanie Turner Email and Phone Number

• Ensure compliance with regulatory bodies for products supplied where Creo are MA holders, Own label suppliers, distributors and wholesalers.• Ensure all licenses and documentation are in place for supply of imported specials and CD products. • After delivery of released product review documentation to ensure compliance and approve stock for sale.• Manage internal audits of facilities and external audits of suppliers to ensure compliance.• Host regulatory bodies inspections.• Implement and maintain the QMS and processes.• Prepare and maintain technical agreement with logistics suppliers, contract warehouse, CMOs, CPOs, importation/ release/testing sites and manage the quality compliance with contractors.• Manage the change control system, the adverse events/complaint process and act as deputy for PV onsite.• Manage the deviation system, conduct quality risk management and root cause analysis to establish effective CAPAs.• Compile and write Period Quality Reviews.• Work with the business development department and within the new products introduction team to launch products

Conducting Batch Reviews, writing PQR, Deviation investigation

Manage a small team with the responsibilities for, deviation management, customer complaints handling, GMP training, internal auditing against ISO and GMP

Batch review, writting and updating SOPs, conducting mock recall, producing metric for management review

Completed and reviewed the quality agreement template against the Rules and Guidance for Pharmaceutical Manufacturers and Distributors.Conducted gap analysis between current quality agreements, approved suppliers list, required review period, to create a remediation plan and authored agreements to the plan. Managed the internal and external audit schedule.Managed the approved supplier list.