知名CRO公司招聘Director-GMP Support group ( Senior Principal Scientist)
<DIV>客户公司:美国上市CRO公司</DIV><DIV>工作地点:上海</DIV>
<DIV>职位描述:</DIV>
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<P style="MARGIN-TOP: 0pt; TEXT-INDENT: -21pt; MARGIN-BOTTOM: 0pt; MARGIN-LEFT: 21pt" class=p0><FONT face=Arial><SPAN style="FONT-FAMILY: 'Times New Roman'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'">1. </SPAN><SPAN style="FONT-FAMILY: '宋体'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'">Lead a supportive team, which covers document management, equipment/instrument management, equipment calibrations and maintenance, </SPAN><SPAN style="FONT-FAMILY: 'Times New Roman'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'">facility</SPAN><SPAN style="FONT-FAMILY: '宋体'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'"> cleaning, and supporting CT manufacturing.</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 12pt; mso-spacerun: 'yes'"></SPAN></FONT></P>
<P style="MARGIN-TOP: 0pt; TEXT-INDENT: -21pt; MARGIN-BOTTOM: 0pt; MARGIN-LEFT: 21pt" class=p0><FONT face=Arial><SPAN style="FONT-FAMILY: 'Times New Roman'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'">2. </SPAN><SPAN style="FONT-FAMILY: '宋体'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'">Organize, instruct and supervise the IQ/OQ/PQ activities for new equipments and GMP facilities.</SPAN><SPAN style="FONT-FAMILY: '宋体'; FONT-SIZE: 12pt; mso-spacerun: 'yes'"></SPAN></FONT></P>
<P style="MARGIN-TOP: 0pt; TEXT-INDENT: -21pt; MARGIN-BOTTOM: 0pt; MARGIN-LEFT: 21pt" class=p0><FONT face=Arial><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 12pt; mso-spacerun: 'yes'">3. </SPAN><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 12pt; mso-spacerun: 'yes'">Cooperate </SPAN><SPAN style="FONT-FAMILY: '宋体'; FONT-SIZE: 12pt; mso-spacerun: 'yes'">with QA department regarding to equipment and facility qualification and product quality related issues. Initiate SOP writing and revision.</SPAN><SPAN style="FONT-FAMILY: '宋体'; FONT-SIZE: 12pt; mso-spacerun: 'yes'"></SPAN></FONT></P>
<P style="MARGIN-TOP: 0pt; TEXT-INDENT: -21pt; MARGIN-BOTTOM: 0pt; MARGIN-LEFT: 21pt" class=p0><FONT face=Arial><SPAN style="FONT-FAMILY: 'Times New Roman'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'">4. </SPAN><SPAN style="FONT-FAMILY: '宋体'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'">Coordinate with Engineering Department for equipment installation, GMP facility modification and expansion.</SPAN></FONT></P>
<P style="MARGIN-TOP: 0pt; TEXT-INDENT: -21pt; MARGIN-BOTTOM: 0pt; MARGIN-LEFT: 21pt" class=p0><FONT face=Arial><SPAN style="FONT-FAMILY: '宋体'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'">职位要求:</SPAN></FONT></P>
<P style="MARGIN-TOP: 0pt; TEXT-INDENT: -21pt; MARGIN-BOTTOM: 0pt; MARGIN-LEFT: 21pt" class=p0><SPAN style="FONT-FAMILY: '宋体'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'"></SPAN><SPAN style="FONT-FAMILY: '宋体'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'"><FONT face=Arial><FONT size=3><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 11pt; mso-spacerun: 'yes'">1. </SPAN><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 11pt; mso-spacerun: 'yes'">MS or Ph.D. degree in Pharmaceutics or other directly related science discipline with experience or training in formulation development and manufacturing</SPAN></FONT></FONT></SPAN></P>
<P style="MARGIN-TOP: 0pt; TEXT-INDENT: -21pt; MARGIN-BOTTOM: 0pt; MARGIN-LEFT: 21pt" class=p0><SPAN style="FONT-FAMILY: '宋体'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'"><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 11pt; mso-spacerun: 'yes'"></SPAN><FONT face=Arial><FONT size=3><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 11pt; mso-spacerun: 'yes'">2. </SPAN><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 11pt; mso-spacerun: 'yes'">Must be proficient with the requirements of the s-FDA/US-FDA/ EMEA cGMP regulations, ICH guidelines as well as drug development process. </SPAN></FONT></FONT></SPAN></P>
<P style="MARGIN-TOP: 0pt; TEXT-INDENT: -21pt; MARGIN-BOTTOM: 0pt; MARGIN-LEFT: 21pt" class=p0><SPAN style="FONT-FAMILY: '宋体'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'"><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 11pt; mso-spacerun: 'yes'"></SPAN><FONT face=Arial><FONT size=3><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 11pt; mso-spacerun: 'yes'">3. </SPAN><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 11pt; mso-spacerun: 'yes'">Prior experience in working in GMP environment. </SPAN><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 11pt; mso-spacerun: 'yes'">Must be able to work in a team-oriented manner in order to accomplish performance objectives.</SPAN></FONT></FONT></SPAN></P>
<P style="MARGIN-TOP: 0pt; TEXT-INDENT: -21pt; MARGIN-BOTTOM: 0pt; MARGIN-LEFT: 21pt" class=p0><SPAN style="FONT-FAMILY: '宋体'; COLOR: rgb(0,0,0); FONT-SIZE: 12pt; mso-spacerun: 'yes'"><FONT face=Arial><FONT size=3><SPAN style="FONT-FAMILY: 'Times New Roman'; FONT-SIZE: 11pt; mso-spacerun: 'yes'">如有意者可联系 <A href="mailto:liz@genhr.com">liz@genhr.com</A> 或<A href="mailto:liz185299608@163.com">liz185299608@163.com</A></SPAN></FONT></FONT></P></SPAN></DIV>
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