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Vendor Quality Support

Company: Integrated Resources, Inc
Location: Smyrna
Posted on: January 10, 2021

Job Description:

Job Title: Vendor Quality Support Location- Smyrna, GA 30080 Duration:12 months ROLE and RESPONSIBILITIES MAJOR ACCOUNTABILITIES * Review annual stability protocol and reports. Communicate any trends to the Vendor Quality Lead (VQL). * Perform review of CMO PQR within agreed timeframe, complete PQR Assessment and discuss outcome with VQL. * Participate to Quality Agreements (QAA) periodic reviews and draft QAA according to available templates. * Perform stakeholder review of various change controls, support change control preparation, keeping change control trackers up to date accordingly. Participate on ad-hoc basis to the client Product Change Control Committees. * In specific cases, review Validation and Technical Transfer protocols and reports liaising with VQL. * Review Master Batch records changes linked to change controls or to support initiation. * investigations/deviations/ out-of-specifications. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (client Vendor Team, GQL, CAS, Business) to allow and perform assessment. * If needed work with the Vendor Quality Lead, the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinate vendor quality related investigations. * Support Audits preparation at client or at the vendors, when relevant act as SPOC in case of client audits and follow-up CAPAs in Trackwise. * Support Risk based evaluation of the vendors in collaboration with VQLs. * Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the assigned products and activities at the vendors. This can include participation to various QA improvement projects. * Act as partial back up for other Vendor Quality Leads in times of absenteeism (e.g. Vacation, illness, etc.) * Work in accordance with client HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.. * Quality Complaints: Perform trend, recurrence analysis with the Central Complaint Unit, escalating issues to VQL. Be a contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the client Complaint System and provision of responses to the complainant are professionally coordinated and managed. EDUCATION & QUALIFICATION * Bachelor's Degree * Master's Degree * Ph.D. * Law (J.D.) * Medical Degree (M.D.) Experience: * 5-10 years professional experience & knowledge in a Quality role in the pharmaceutical industry preferably in the GMP operations environment * Knowledge with pharmaceutical formulations (e.g., tablets, capsules, oral solutions, injectables, transdermal systems) * In-depth knowledge with the manufacture / testing of pharmaceutical formulations (e.g., tablets, capsules, oral solutions, injectables, transdermal systems) * Hands-on field experience in failure investigations, root cause analysis, deviation review * Solid knowledge about European Good Manufacturing Practices (Eudralex Vol. 4) SDL2017

Keywords: Integrated Resources, Inc, Smyrna , Vendor Quality Support, Other , Smyrna, Georgia

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