• Gaithersburg , MD
  • Scientific Research
  • Full-Time
  • 12018 Blackberry Terrace

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Job Description The incumbent is responsible for the Quality management of assigned Quality system and compliance activities for GSQ supply chains and suppliers. They are responsible for all Quality activities that directly support execution of assigned Quality Management System elements. QSMs will be assigned in discussion with their line management, key areas of responsibility, but will be expected to learn other areas of the quality system to help support the rest of the team during times of peak workload or holiday coverage. This includes, but is not limited to, the Quality System oversight andor performance of the following activities Product quality complaint, Temperature Excursions or SL complaint management Deviation investigations, quality issue management and escalation Product release (Career Level D required) Quality system element governance as either BPO or deputy BPO Certification reports Change control SOP management Stability Data entry and management Supply Chain Assurance (SCA) system administration Training System Self-Inspection auditing Quality Risk Management Quality Agreements (establishment and maintenance) between AZ and External Suppliers and between GSQ and AZ Operations Sites. Responsibilities Complaints Management - Coordinate complaints issued for GSQ as a supplying site or coordinating site Product Quality Complaints Temperature Excursion Supply and Logistics (support when applicable) Product security Supports GSQ Quality Management Systems Manages and maintains quality data and records in relevant quality management support systems (GQCLIMS, SAP and OCM) as required. SCA data entry and checks Stability Data entry and secondary data checks Assists in the production of, or contribution to, quality documentation as GSQ SOPs. Manages internal deviations in Track wise deviation system. Supports with data for certification reports. Essential Requirements Bachelor degree in a science technical field such as Pharmacy, Biology, Chemistry or Engineering (Note there may be specific additional requirements depending on the regulations in each country). Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc. Excellent oral and written communication skills English and local language(s) Desirable Skills Experience working in a PCOPET organization or LeanSix Sigma training. Multi-site multi-functional experience Proven experience in Quality Assurance or combination of Quality and Technical Masters Degree in Quality AssuranceRegulatory Affairs or other advanced scientific field
Associated topics: aseptic, drug, histologist, histology, immunology, industrial hygienist, pharmacy, protein, transfection, virus

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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