Director Quality & Regulatory Affairs

Employer
Granules Pharmaceuticals Inc
Location
Chantilly, Virginia
Posted
Mar 15, 2017
Closes
Apr 14, 2017
Function
Other
Hours
Full Time


Granules Pharmaceuticals Inc has openings for mult. positions in Chantilly, VA for Director Quality & Regulatory Affairs: Rvw investigations & mng decision-making prcss of Field Alert Rprt, prdct recall filing, label submissions, handle regulatory compliances, Direct internal audit prcss ovrsee change ctrl impct analysis. Manager Facilities: Maintain facility & eqpmt in strong operating condition as per FDA & DEA rqmts. Trblsht very lrg scale integrated circuits & prfrm'g installations, qualifications & upgrades of machines. Sr. Manager - Formulation Development: Lead team of scientists to advnce prjcts frm exploratory dvlpmt thru various clinical stages, validation of solid oral dosage forms, Prep & rvw tech'l rprts/protocols & formulation dvlpt rprt. Associate Director Formulation Development: Lead team of scientists to advnce prjcts frm exploratory dvlpmt thru various clinical stages, prfrm formulation dvlpmt of modified release dosage forms, prcss dvlpmt, writing tech'l rprts, handling CMC deficiency responses & prfrm prcss validation of drug prdcts. Chemist II: Prfrm routine analytical tsts of pharmaceutical raw materials, in-prcss samples, blends, finished prdcts & stability samples using instrumentation like HPLC, LCMS, UPLC, GC, Uv/vis, FTIR, TOC, Dissolution, particle size analyzer, SEM, surface area analyzers etc. Tst & eval. prdcts, maint. lab. instrumentation, logbooks, tst rslts, databases & notebooks, Prfrm verification of compendia method & metrology functions. Send Resume & position to: Granules Pharmaceuticals Inc, Attn: HR Dept, 3701 Concorde Pkwy, Chantilly, VA 20151.