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Deputy Quality & Regulatory Affair Manager - San Francisco, California
BioQ Pharma Incorporated
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BioQ Pharma Incorporated has an opportunity for Deputy Quality & Regulatory Affair Manager (8am-5pm, Mon-Fri,$141,835/yr, 40 hrs/week, standard benefits apply) in San Francisco, CA. Manage quality aspects of design & devlpmnt of unit-dose infusion systems. Duties include: Documentation & implementation of hybrid QMS. Supplier monitoring/audit. Mgmt quality systems aspects of product release. Ongoing mgmt of ISO (International Standards Organization) registration, preparation for surveillance audit. Tasks normal & customary for being “management representative” of quality mngmnt system (mngmnt review, internal audits, etc. etc.). Submission & mngmnt of Technical Files for CE Marks. Mngmnt of pharma dossiers, incl consultants that may be undertaking local registrations. Mngmnt of clinical trials – specifically monitoring CRO performance, etc. Tasks one would reasonably undertake in managing quality systems of drug device combination technlgy. Requires MS degree or foreign degree equiv in Biomedical Engineering or rltd field & knowledge of or experience in following: Quality Mangmnt Systems & regulatory processes for both Pharma & Medical Devices; Process of design & dvlpmnt of medical devices & included concept dvlpmnt, prototype dvlpmnt through examples, verification & validation concepts, design transfer, market release & post marketing activities; Quality Regs incl 21 CFR 820, ISO 13485, ISO 14971, ISO 10993, & FDA principles on design & process validations; Design & devlpmnt planning including implementing regulatory & legal requirements on healthcare product; Drafting sample design & manufacturing documentation; Pharmaceutical Good Manufacturing Practices (per part 211 & EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines); Post-marketing activities, such as complaint handling, vigilance & advisory notices & pharmacovigilance; Non-conformance, including root cause investigations by issuing corrective & preventive actions, having end to end product traceability & supplier mngmnt activities. Send resumes to Recruitment & Employment Office, BioQ Pharma Incorporated, Attn: Job Ref #: Bio60943, P.O. Box 56625, Atlanta, GA 30343.
Primary Skills: Please refer to Job Description
Salary: Between 141835 - 141835
Experience Required: 0, years minimum
Clearance Level: 0
Travel: %
Other Details:
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