We are seeking a Senior GMP QA Officer for our Greenfield, IN site. This position will support the large molecule GMP/CMC group. Will be responsible for the following:
Supports the implementation of the global GMP quality management system, helping to ensure that site specific requirements are addressed locally.
Monitors and reports on appropriate site metrics and data trends related to the performance of the site quality management system for input into the Management Review Process.
Reviews and approves site quality documents (SOPs, Policies, etc) to ensure compliance with GMP, Covance document management procedures and other applicable quality standards.
Supports the supplier qualification programme by participating in assessments and leading third party audits.
Provides regulatory approval of study related documentation (i.e. batch records, protocols, reports, certificates of analysis, etc) prior to release to the Client.
Supports the GMP QA internal audit programme by scheduling, planning, leading, reporting and following up of system, process and facility audits.
Participates in projects to ensures facilities, utilities, equipment and computer systems are appropriately validated/qualified; approval of key validation deliverables.
Leads and approves investigations (deviations, OOS, customer complaints, etc) into the cause and resolution of quality defects.
Participates to the development and delivery of GMP training, including training of QA during external audits.
Provide advise and guidance and independent review to the site on aspects of quality and GMP compliance.
Deputizes for the GMP QA Manager in Leading the Management Review Process and in hosting Client and Regulatory Authority inspections, coordinating the response to observations and follow-up of corrective actions.
Represents Covance GMP QA at conferences and seminars.
Liaises with external suppliers/subcontractors in order to arrange inspections of their facilities.
A minimum of a Bachelors Degree in a Pharmacy, Chemistry or Biology related discipline
Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable
A minimum of 8 years of experience in a GMP environment with quality expertise. Preferably in cGMPs, late phase clinical cGMPs/GCP.
In depth knowledge of Good Manufacturing Practice Regulations and related industry standards/guidance (e.g. ICHQ10,ICHQ9, ISO 9000), specifically as they pertain to clinical trials and the clinical supply chain
Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving
Experienced GMP Auditor and Lead auditor of external audits
Experience in process improvement
Customer service orientated, i.e. ability to interact effectively with clients and regulatory authorities