Suchergebnisse: 24 Stellenangebote
89.600€ pro Jahr
...analytical sub-team with cross functional members
Leading and coordinating timely delivery of high quality source documents for submission, review of regulatory documents (e.g. CMC modules, briefing books) and interactions with Health Authorities in audits and scientific...
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PhD Position
Teilzeitarbeit
Homeoffice
60.600€ pro Jahr
...development, production, quality assurance and regulatory department
• Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents...
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Teilzeitarbeit
Homeoffice
43.548,4€ pro Jahr
...existing and new digital tools
• Drive continuous improvement activities of lab procedures and workflows
• Author and review technical documents (e.g. instrument/lab procedures) and provide input to scientific reports by adequate raw data documentation and...
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Teilzeitarbeit
Homeoffice
60.600€ pro Jahr
...completion of remediation activities; ensures creation of and reviews relevant remedial and improvement actions for Corrective Action... ...in CMC modules
• Submission support: Support the CMC documentation preparation by facilitating timely provision of good quality source...
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Teilzeitarbeit
Homeoffice
66.800€ pro Jahr
...defined segments. Driving and optimizing strategic outsourcing as well as troubleshooting, deviation handling, and writing/reviewing technical documentation are among the assigned responsibilities.
About the Role
KEY RESPONSIBILITIES:
Your responsibilities include,...
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Teilzeitarbeit
Homeoffice
...estimations and ensure execution methodology (e.g. client interviews; documentation analysis). May take overall responsibility for specific area... ...demonstrate special project features, leading design and code reviews.
Develop functional and detailed designs, implement and...
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Ausbildungsplatz
Vollzeit
2.800€ pro Monat
...meetings on damage cases with the affected divisions and management.
~Independently reviewing and approving damage invoices.
~Establishing a damage database including corresponding documentation/statistics.
Your strengths and qualifications
YOUR STRENGTHS...
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Homeoffice
60.212,18€ pro Jahr
...activities (planning, authoring, reviewing, coordination, submission)... ....
• Identify the required documentation and any content, quality and... ...approved technical source documents in accordance with project timelines.
• Author and/or review high-quality CMC...
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...activities with the project team members for assigned projects. You will also author and review the deliverables assigned to RMCS and drive the preparation of the function related documents (sections) for the registration of Medical Device/Combination Product (examples:...
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53.000€ pro Jahr
...Zusammenarbeit mit den fachlichen Abteilungen und die Generierung von Testcode für die Applikation (Unit Tests) und gegenseitiger Code Review
Das bringst du mit:
Technisch fundierte Ausbildung in der Softwareentwicklung, zusätzlich ist Erfahrung in SCRUM vorteilhaft...
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Vollzeit
Teilzeitarbeit
Im Frühling
Ausbildungsplatz
Weltweit
FH Kufstein
Kufstein
Vor 9 StundenNeu
...specification, etc.
coordinate CP-related projects with internal and external business partners
plan and implement periodic reviews of CPs within CQF in close collaboration with the QA and QC
collaborate and optimize cross-functional activities regarding CPs (...
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60.212,18€ pro Jahr
...strategy and direction for timely preparation of high-quality CMC documentation to support new regulatory submissions for complex new product... ...and coordinate the availability of approved technical source documents in accordance with project timelines
• Write high-quality...
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Teilzeitarbeit
Homeoffice
54.735,38€ pro Jahr
...Contribution to the KPIs and operational excellence
Ensuring all activities are in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release), stability testing.
Preparation of SOPs, protocols, laboratory procedures...
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Teilzeitarbeit
Homeoffice
43.548,4€ pro Jahr
...calibration of equipment as well as housekeeping
-Ensures an adequate level of education, GMP knowledge
-Adherence to good documentation practice and data integrity regulations
-Preparation for and participation in inspections (regulatory authorities, customers,...
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Teilzeitarbeit
Homeoffice
57.579€ pro Jahr
...Deine Rolle im Team
Manage operational support tickets to maintain SLA and backlog
Drive review calls with various support teams
Drive Oracle service request resolutions and metrics
Make sure support teams collaborate and follow our processes
Drive improvements...
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Ausbildungsplatz
Vollzeit
Offshore
Flexible Arbeitszeit
60.212,18€ pro Jahr
...Harmonization of Processes between DP1 & DP2, further rollout of established systems (e.g. MES,....)
• Execution of IQ/OQ/PQ ... Testing, Documentation, Compliance
• Initiation and Evaluation including Coordination; Change and CAPA Management (Agile Changes)
Role Requirements...
Teilzeitarbeit
Homeoffice
60.212,18€ pro Jahr
...Planning, design and optimization of packaging and packaging processes in accordance with GMP requirements
• together with suppliers review, optimize and implement packaging materials (suitability and conformity)
• Optimization and further development of existing...
Homeoffice
53.068€ pro Jahr
...solutions
Break down functional requirements into clear and actionable technical specifications, user stories/development tasks
Document functionality and features developed for future reference
Ensure project delivery on time within budget and scope while...
Ausbildungsplatz
Vollzeit
Flexible Arbeitszeit
54.735,38€ pro Jahr
...communicating results to our technical teams.
As the MS expert, you'll help decide on next steps. You'll also prepare technical documents and reports, participate in function-specific sub-teams, and share your knowledge with your team members. Minimal direction will...
Teilzeitarbeit
Homeoffice
54.735,38€ pro Jahr
...in case of issues during operations, as well as troubleshooting in production (24/7 - shift model)
• QA Investigation (writing and review as QA approver)
• Prevention activities: oversight on CAPAs implementation and control activities in production (e.g. AQLs, 100%...
Weltweit
Homeoffice
