1. ÑÏ¿á×ñÊØ¹«Ë¾µÄ¸÷Ïî¹æÕÂÖÆ¶È£¬¹á³¹Ö´Ðй«Ë¾ÓªÏúÕþ²ß£¬Î¬»¤¹«Ë¾ÀûÒæ£¬Î¬»¤¹«Ë¾Æ·ÅƺÍÐÎÏó¡£
2. ÓªÒµ¿ªÍØ£ºÎ¬»¤ÀϿͻ§£¬×ÔÐпª·¢Ð¿ͻ§£¬Æð¾¢¸æ¿¢¹«Ë¾ÓªÒµÄ¿µÄ£»×·ÇóÓÅÖÊÏàÖúͬ°é£¬Î¬»¤ÓÅÒìµÄÏàÖú¹ØÏµ¡£
3. Êг¡ÆÊÎö£ºÏàʶÊг¡¶¯Ì¬£¬ËѼ¯¡¢Í³¼ÆºÍÕûÀíÊг¡¿Í»§ÂþÑÜ¡¢ÐÐÒµÂþÑܵȿͻ§×ÊԴ״̬¡£
4. Êг¡ÖÈÐò£ºÎ¬³ÖÊг¡ÖÈÐò£¬¼ç¸ººÍ¹æ±ÜÊг¡Î£º¦£¬½â¾öÊг¡Í»·¢ÊÂÎñ¡£
5. »Ø¿î¸ú×Ù£ºÓªÒµ»Ø¿î¸ú×Ù£¬Ê¶±ð²¢¹æ±Ü²»Á¼ÕË¿îΣº¦¡£
6.е÷±¾²¿·ÖÓ빫˾ÆäËü²¿·ÖµÄÓªÒµ¹ØÏµ£¬Íê³ÉÉϼ¶Ïòµ¼½»°ìµÄÆäËû¸÷ÏîÊÂÇéʹÃü¡£
1. ´óרÒÔÉÏѧÀú£¬Êг¡ÓªÏú¡¢µç×ÓÉÌÎñµÈרҵ£»
2. 1ÄêÒÔÉÏÏúÊÛÊÂÇéÂÄÀú£¬¼ì²âÈÏÖ¤ÐÐÒµÓÅÏÈ£»
3. ÊìϤ²úÆ·¸÷¹ú²úÆ·ÈÏÖ¤»ù±¾ÖªÊ¶¡¢Ïàʶ¸÷¹ú²úÆ·ÈÏÖ¤Á÷³Ì¼°ÒªÇó£¬ÕÆÎÕ²¢ÔËÓÃÉÌÎñÏúÊÛ֪ʶ¡¢ÏúÊÛ¼¼ÇɺÍÒªÁ죻¿Í»§ÇéÐÎÏúÊÛÆÊÎöÄÜÁ¦¡¢²úÆ·ÈÏ֤֪ʶ×ܽáÓÅ»¯ÄÜÁ¦£»
4. ÓÅÒìµÄÏàͬ±í´ïÄÜÁ¦£¬ÊìÁ·ÕÆÎÕµçÄÔ³£Óð칫Èí¼þ£¬ÓÅÒìµÄÔðÈÎÐÄ£¬×Ô¶¯ÐÔ£¬Ö´ÐÐÁ¦ºÍ¿¹Ñ¹ÄÜÁ¦¡£
ÓÊÏäͶµÝ£ºhr@szhtw.com.cn
1. ÖÊÁÏ»¯Ñ§ÆÊÎöÓë²âÊÔ£º¶ÔÒ½ÓÃÖÊÁÏ£¨Èç¸ß·Ö×ÓÖÊÁÏ¡¢½ðÊôÖ²ÈëÎï¡¢ÉúÎï½µ½âÖÊÁϵȣ©¾ÙÐл¯Ñ§ÒòËØÆÊÎö£¬°üÀ¨¿ÉÁ¤ÂËÎï¡¢Ìí¼Ó¼Á¡¢µ¥Ìå²ÐÁô¡¢ÖؽðÊô¡¢Óлú»Ó·¢ÎVOCs£©µÈµÄ¼ì²â£»
2. Ö´Ðл¯Ñ§±íÕ÷£¨ISO 10993-18£©£¬ÆÀ¹ÀÖÊÁÏÓëÈËÌå½Ó´¥µÄ»¯Ñ§Î£º¦£»
3. ʵÑéÉè¼ÆÓëÒªÁ쿪·¢£ºÆ¾Ö¤ISO¡¢USP¡¢GBµÈ±ê×¼£¬¿ª·¢²¢ÑéÖ¤»¯Ñ§ÆÊÎöÒªÁ죨ÈçHPLC¡¢GC-MS¡¢ICP-MS¡¢FTIRµÈ£©£»
4. Éè¼Æ½þÌáʵÑ飨¼ÓËÙ/Ä£Äâ½þÌᣩ£¬ÆÊÎöÖÊÁÏÔÚ²î±ðÌõ¼þÏµĻ¯Ñ§ÊÍ·ÅÐÐΪ£»
5. ÆÊÎöʵÑéÊý¾Ý£¬±àдÇкÏî¿ÏµÒªÇóµÄ¼ì²â±¨¸æ£¨ÈçFDA¡¢CE¡¢NMPAÑо¿ÐÔ×ÊÁϱ¨¸æ£© £¬Ö§³ÖÉúÎïÏàÈÝÐÔÆÀ¹À£¨ISO 10993ϵÁУ©£¬Ìṩ»¯Ñ§±íÕ÷Êý¾ÝÒÔ¸¨Öú¶¾ÀíѧÆÀ¹À£»
6. Íê³ÉÉϼ¶Ïòµ¼°²ÅŵįäËûÊÂÇé¡£
1. ±¾¿Æ¼°ÒÔÉÏѧÀú£¬»¯Ñ§¡¢ÆÊÎö»¯Ñ§¡¢ÖÊÁÏ¿ÆÑ§¼°Ò©Ñ§µÈÏà¹Ø×¨Òµ£¨Ë¶Ê¿ÓÅÏÈ£©£»
2. 3ÄêÒÔÉÏÒ½ÁÆÆ÷е/Ò½Ò©ÐÐÒµ»¯Ñ§ÆÊÎöÂÄÀú£¨Ó¦½ìÉúÐè¾ß±¸Ïà¹Ø¿ÎÌâÑо¿ÂÄÀú£©£¬ ÓÐÒªÁìѧÑéÖ¤»òʵÑéÊÒÈÏÖ¤£¨CNAS¡¢CMA£©ÂÄÀúÕßÓÅÏÈ£»
3. ÊìϤҽÁÆÆ÷еÐÐÒµ£¬ÏàʶÎÞÔ´Ò½ÁÆÆ÷е£¨µ¼¹Ü£¬·ìºÏÏߣ¬Ö²ÈëÎµÄÖÊÁÏÌØÕ÷£¬ÊìÁ·²Ù×÷»¯Ñ§ÆÊÎöÒÇÆ÷£¨ÈçHPLC¡¢GC-MS¡¢ICP-OES/MS¡¢LC-MS¡¢FTIRµÈ£©£»
4. ÕÆÎÕ»¯Ñ§±íÕ÷Á÷³Ì£¨ÌáÈ¡Îï&¿ÉÁ¤ÂËÎïÑо¿£¬E&L£©ºÍ¶¾ÀíѧãÐÖµ£¨AET/TTC£©ÅÌË㣬ÊìϤÖÊÁϽµ½â²úÆ·ÆÊÎö£¨ÈçPLA/PGA½µ½âÑо¿£©£»
5.ÏàʶҽÁÆÆ÷еע²áÉ걨ҪÇó£¨ÈçFDA 510(k)¡¢ÖйúNMPA£©ÊìϤISO 10993ϵÁбê×¼¡¢USP <661>¡¢ICH Q3DµÈ±ê×¼¡£
ÓÊÏäͶµÝ£ºhr@szhtw.com.cn
1.ÈÏÕæÆ¾Ö¤¿Í»§ÒªÇó¼°»òº£ÄÚÍâÏà¹Ø±ê×¼¹æÔòÉè¼ÆÌåÀý¶¯ÎïÊÔÑ鼯»®£»
2.ÈÏÕæÊÔÑéÀú³ÌµÄʵÑé¡¢¼àÊÓ¡¢ÊÔÑéÊý¾ÝµÄÍøÂç¡¢ÕûÀí£»ÊÔÑ鱨¸æµÄ׫д¡¢Ú¹ÊÍ£»
3.ÈÏÕæ¶¯ÎïÊÔÑéÏà¹Ø²Ù×÷¹æ³ÌµÄÖÆ¶©£¬ÒÔ¼°Ïà¹ØÊÖÒÕÖ°Ô±µÄÅàѵ£»
4.ÈÏÕæÐÖúÖÊÁ¿²¿·ÖÍê³ÉCNAS¡¢CMA¡¢GLPµÈµÄ¼ì²éÓëʵÑé¡£
1.˶ʿѧÀú£¬Ò½Ñ§¡¢Ò©Ñ§¡¢ÊµÑ鶯Îï¡¢ÉúÎï»òÃâÒßµÈÏà¹Ø×¨Òµ£¬Á½ÄêÒÔÉÏÊÂÇéÂÄÀú£»
2.Ó¢ÓïËļ¶¼°ÒÔÉÏ£¬ÊìÁ·Ê¹Óð칫Èí¼þ£»
3.ÓÐʵÑ鶯ÎïÉϸÚÖ¤»òÖ´ÒµÊÞÒ½×ʸñÖ¤ÓÅÏÈ¡£
ÓÊÏäͶµÝ£ºhr@szhtw.com.cn
1.¶ÔʵÑ鶯Îï¼²²¡¾ÙÐÐÆðÔ´Õï¶Ï£¬ÈçÅäÒ©¡¢×¢Éä¡¢ÊäÒºµÈ£»
2.¶ÔʵÑ鶯Î￵½¡ºÍ¸£ÀûÈÏÕæ£¬ÐÖúʵÑ鶯ÎïÂ×ÀíίԱ»á¶Ô¶¯ÎïʵÑ鼯»®Ö´ÐÐÇéÐξÙÐмàÊÓ·´ÏìºÍÏà¹ØµÄÊÖÒÕ×Éѯ£»
3.ÊìϤҩÀíҩЧʵÑ飬ÄÜ×ÔÁ¦°´¹æ·¶¿ªÕ¹¶¯ÎïʵÑéµÈ£¬Äܹ»×ÔÁ¦Íê³ÉÈ®¡¢Öí¡¢ÍõÈÏà¹Ø¶¯Îï?ÊÔÑ飻
4.ÓеÚÈý·½¼ì²âÂÄÀúÊÂÇéÕßÓÅÏÈ¡£
1.±¾¿Æ¼°ÒÔÉÏѧÀú£¬ÊÞҽѧ¡¢¶¯Îïҽѧ¡¢ÁÙ´²ÊÞҽѧ¡¢»ù´¡ÊÞҽѧµÈÏà¹Ø×¨Òµ£¬ÓµÓÐÖ´ÒµÊÞÒ½Ö¤£»
2.ÓÐ2-3Äê´óÐÍÖí³¡ÊÞÒ½ÊÂÇéÂÄÀú»òÕß³èÎïÒ½ÔºÊÂÇéÂÄÀú£¬ÊìÏ¤ÕÆÎÕ´ó¶¯Îï»òС¶¯Îï¼²²¡µÄ·ÀÖÎÊÖÒÕ¡£
ÓÊÏäͶµÝ£ºadminsz@szhtw.com.cn
1.µµ°¸È«ÉúÃüÖÜÆÚÖÎÀí£º
ÈÏÕæÖ½Öʼ°µç×Óµµ°¸µÄÎüÊÕ¡¢¹ÒºÅ¡¢·ÖÀà¡¢±àÄ¿¡¢´æ´¢¼°°´ÆÚÅÌ»õ£»
ά»¤µµ°¸ÖÎÀíϵͳ£¨ÈçEDMS/µç×ÓÎĵµÖÎÀíϵͳ£©£¬È·±£Êý¾Ý׼ȷÐÔÓë¼ìË÷ЧÂÊ£»
Ö´Ðеµ°¸½èÔÄ¡¢ËÍ»¹¡¢Ïú»ÙµÄÉóÅúÁ÷³Ì£¬¼Í¼²Ù×÷ÈÕÖ¾±¸²é¡£
2.ºÏ¹æÓëÇå¾²ÖÎÀí£º
È·±£µµ°¸ÖÎÀíÇкÏISO 15489£¨ÐÅÏ¢ÓëÎĵµÖÎÀí±ê×¼£©¡¢GDPR¼°¹«Ë¾±£ÃÜÖÆ¶È£»
°´ÆÚ¼ì²éµµ°¸´æ´¢ÇéÐΣ¨·À»ð¡¢·À³±¡¢·À³æ£©£¬ÖÎÀí¼ÓÃܵç×Óµµ°¸µÄ»á¼ûȨÏÞ£»
ÅäºÏÄÚÍⲿÉ󼯣¬Ìṩµµ°¸µ÷ÔÄÖ§³Ö¼°ºÏ¹æÐÔ֤ʵÎļþ¡£
3.¿ç²¿·ÖÐ×÷£º
¶Ô½Ó¼ì²â²¿·Ö¡¢ÖÊÁ¿²¿¼°¿Í»§·þÎñ²¿£¬ÕûÀí¹éµµ¼ì²â±¨¸æ¡¢Ð£×¼Ö¤ÊéµÈÊÖÒÕÎĵµ£»
ÐÖúIT²¿·ÖÓÅ»¯µç×Óµµ°¸±¸·ÝÕ½ÂÔ£¨ÈçNAS/ÔÆ´æ´¢£©£¬Öƶ©ÔÖÄѻָ´ÍýÏë¡£
4.Á÷³ÌÓÅ»¯£º
Ìá³öµµ°¸ÖÎÀíÁ÷³Ìˢн¨Òé£¬ÍÆ¶¯Êý×Ö»¯¹éµµ¹¤¾ßµÄÓ¦Óã¨ÈçOCRɨÃè¡¢ÌõÐÎÂëÖÎÀí£©£»
±àдµµ°¸ÖÎÀí²Ù×÷Ö¸ÄÏ£¬×éÖ¯ÄÚ²¿Åàѵ¡£
1.µµ°¸ÖÎÀí¡¢ÐÅÏ¢ÖÎÀí¡¢ÐÐÕþÖÎÀíµÈÏà¹Ø×¨ÒµÓÅÏÈ£¬´óר¼°ÒÔÉÏѧÀú£»
2.1ÄêÒÔÉϵµ°¸ÖÎÀíÂÄÀú£¬Óмì²âÈÏÖ¤¡¢Ò½ÁÆÆ÷е¡¢ÖÆÔìÒµ»òʵÑéÊÒÅä¾°ÕßÓÅÏÈ£»
3.ÊìϤISO 17025¡¢GMPµÈÖÊÁ¿ÖÎÀíϵͳ¶ÔÎĵµ¿ØÖƵÄÒªÇó£»
4.ÊìÁ·Ê¹ÓÃOffice°ì¹«Èí¼þ¼°µµ°¸ÖÎÀíϵͳ£¨ÈçSharePoint¡¢·ºÎ¢OAµÈ£©¡£
5.¾ß±¸»ù´¡ÐÅÏ¢»¯ÄÜÁ¦£¨Èçµç×Óµµ°¸·ÖÀà¹æÔòÉè¼Æ¡¢Êý¾Ý¿â¼òÆÓÅÌÎÊ£©£»
6.ÏàʶÎĵµ¼ÓÃÜ¡¢Êý×ÖÊðÃûµÈÇå¾²ÊÖÒÕ£¬¾ßÓб£ÃÜÒâʶ¡£
ÓÊÏäͶµÝ£ºadminsz@szhtw.com.cn
1.ƾ֤¹ú¼ÊºÍº£Äڵݲ¹æ±ê×¼£¨ÈçIEC60601-1, GB9706.1£©¶Ô²úÆ·¾ÙÐнṹ¼ì²é£¬Ã¶¾Ù×°±¸µÄÒªº¦ÔªÆ÷¼þÇåµ¥£¬Ïò¿Í»§Ìá³ö×ÊÁÏÐèÇó²¢¶ÔÌṩµÄ×ÊÁϾÙÐк˶ԣ»
2.ÒÀ¾Ý¹ú¼ÊºÍº£Äڵݲ¹æ±ê׼͎áÏÖʵ²úÆ·ÖÆ¶©°²¹æ¼ì²âÍýÏëºÍ²âÊÔÊý¾Ýµ¥£¬²¢ÄÜÍê³É°²¹æ²âÊÔ¡¢±àд°²¹æ¼ì²â±¨¸æ£»
3.¶Ô¼ì²âÖеÄȱ·¦¸ñÏîÄ¿£¬¸ø¿Í»§Ìá³öÕû¸Ä½¨Ò飻
4.±¨¸æ¡¢Ôʼ¼Í¼´æµµ£¬±àд²âÊÔ×÷ÒµÖ¸µ¼Ê飬ÐÖúʵÑéÊÒÖÎÀíÖ°Ô±Åàѵ²âÊÔ¹¤³Ìʦ£¬ÐÖúÏúÊÛÖ°Ô±½â¾öÊÖÒÕÎÊÌ⣻
5.бê×¼/ÒªÁìµÄÑо¿¿ª·¢£¬ÐÖúÍØÕ¹ÊµÑéÊÒÄÜÁ¦¹æÄ£¡£
1.½ÌÓýÅä¾°£ºÕûÈÕÖÆ±¾¿Æ¼°ÒÔÉÏѧÀú£¬µçÆø¡¢ µç×ÓµÈÏà¹Ø×¨Òµ£¬Ñо¿ÉúÓÅÏÈ£»
2.ÊÂÇéÂÄÀú£º1ÄêÒÔÉϰ²¹æÈÏÖ¤ÐÐÒµÊÂÇéÂÄÀú (¿É½ÓÊÜÓ¦½ì½áÒµÉú/ʵϰÉú)£»
3.רҵÊÖÒÕ/ÄÜÁ¦£ºÊìϤҽÁÆ»ò IT ²úÆ·µÄº£ÄÚÍâ°²¹æ±ê×¼£»
4.¾ßÓÐÍŶÓÏàÖú¾«Éñ£¬ ÓÅÒìµÄÏàͬÄÜÁ¦¡¢ÔðÈÎÐÄÇ¿£»
5.¾ß±¸ÓÅÒìµÄµç·»ù´¡ÖªÊ¶£»
6.¾ß±¸Ò»¶¨µÄѧϰºÍ¿¹Ñ¹ÄÜÁ¦¡£
ÓÊÏäͶµÝ£ºadminsz@szhtw.com.cn