| Date Posted: | 14/Apr/15 | |
| Requisition: | 2061249 | |
| Job Title: | QPR team lead | |
| Description: | 1. Job Function The teamleader of QPR is responsible for Product Release of products produced on the production lines in Glostrup according to plan. Furthermore the teamleader is responsible for securing team KPIs including corrective actions which include securing sufficient resources and competencies. a)Organizational Reports to QA Operations manager. The position has currently 13 direct reports, whereof 2 are temporary. An addition of 4 employees (2 permanent, 2 temporary) are planned. b)Communication/Contacts: Internal: • Production departments, Planning, Production Support, QA/RA, Planning Department, R&D in Glostrup, Global Supply Chain, Reagent Partnership, Facility Management, IT, Customer Service and Account. External: NA 2. Job Responsibilities: Responsible for providing status on KPI’s as well as overall improvements on a weekely/monthly basis. Reporting is to be aligned with the current form of repoting. Responsible for providing status on ongoing product release on a weekly basis. Responsible for communication to Manager of QA Operations and furthermore overall responsible for communication in own area. • People management o Ensuring that own area of responsibility is manned with the competencies needed to achieve business goals in compliance with headcount guidelines. o Ensure training and develope of own employees. o Involve employees from own area, in important decisions. o Responsible for hiring and termination of own employees in close coordination with Senior Director og Production Site Glostrup. o Management representative for safty groupe in own area. o Vacation and compensation time match demand for resources. o Manning list is updated, and Time repoting(OTL) approved on time. • Qualified Person and Product Release o Final release of finish good products for sale, enduring: o Conformity is appropriately assessed before a batch is released. o The product meets the specifications. o On a daily basis secure that all products are released according to plan. o Support first time release of all new items transferred to production form R&D. o Optimization of batch documentation review and product release processes. | |
| Qualifications: | 1. Education: BSc or MSc in natural sciences, pharmacy or engineering. 2. Experience: Min. 4 y ears in Quality Assurence of In Vitro Diagnistic, Medical Devices and/or Pharmaceuticals. Preferably versed in Quality System Standards (ISO13485,FDA CFR 21 Part 820) and IVD/Medical Devices legislation in EU and USA. Experience in assurance of product quality. Management experience from manufacturing company. Experience with continuous improvement of business processes. Personal competence for this job o High drive and focused on creating results (goal oriented) o Proactive and good at delegating. o Good at setting goals and direction. o Good business understanding and able to drive change. o Good at communicatin, motivating, coanching and working with other in cross functional groups. | |
| Company: | Dako | |
| Business: | Global Infrastructure | |
| Job Category: | Quality/Regulatory | |
| Job Sub-Category: | Quality/Regulatory Mgmt | |
| Region: | Europe | |
| Country or Area: | Denmark | |
| State/Province: | Capital Region of Denmark | |
| Town/City: | Glostrup | |
| Shift: | Day Job | |
| Job Type: | Experienced | |
| Schedule: | Full-time | |
| Travel Required: | No | |
| Duration (Temp Positions Only): | 25-36 months (ITW only) | |
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