The Senior Compliance Manager is responsible for mentoring and coaching compliance managers, creating/executing the vision, strategy & objectives for the GCP Compliance group, ensuring proactive compliance and inspection readiness are integrated into planning and execution of clinical trials and supporting audit/regulatory inspection(s). The Senior Compliance Manger provides guidance to functional/clinical trial and program teams on Clinical Trial Quality Risk Management (CTQRM) and GCP related activities/issues. Key responsibilities: • Provide coaching, guidance, and mentorship to compliance ...

Active participation in the preparation and finalization of Safety Update Reports (SUR) for submission: Stock keeping unit (SKU) mapping reviews linked to sales data Manual calculation of doses sold and percentage incidences of adverse event reports Data integrity - pulling case line listings and performing data quality checks on cases in the PV database within the scope of SUR preparation Extraction and adaptation of SUR templates according to working instructions Reviewing regulatory information to ascertain PV related safety actions or requesting regulatory information from product ...

On behalf of our business partner in the service industry, we are currently looking for helpers in the warehouse in Hagen. Quick entry into working life for newcomers, career changers and of course professionals. Logistics assistants ensure that parcels will arrive all over in Germany the next day. The best thing to do is to apply online today. Randstad stands for experience and competence in your job search. That's what it's all about: Unload parcels from a swap body, register them, load them onto roller containers, assign them to another swap body and load them there to save space.

In your role, you will analyse active pharmaceutical ingredients, intermediates and raw materials by means of HPLC, GC and in accordance with the applicable work regulations. You will evaluate the corresponding analysis results accordingly and subsequently document and archive them. In addition, you will be involved in the development and review of new analytical methods as well as in the implementation of method transfers and verifications. The maintenance, repair and calibration of equipment are also part of your tasks Tasks Examination of active pharmaceutical ingredients, intermediates and ...

Tasks Accompaniment of construction projects from planning supervision to construction or completion, primarily in laboratory buildings Representation of the projects on behalf of the user and responsibility for the qualitative fulfilment of the planning contents Planning support and technical construction management in accordance with HOAI phases 3 to 8 in the trades of ventilation and air conditioning, heating, refrigeration and sanitatio Requirements Master's degree or diploma in the field of supply engineering or an equivalent degree with several years of professional experience Many years ...

The central tank farm consists of storage tanks and filling facilities for storing and filling flammable and water-polluting liquids as well as liquid waste. From the tank farm, the central supply of the production plants with solvents as well as the disposal of liquid waste is carried out. The tasks include carrying out and monitoring filling processes for tank and rail tank cars, preparing and carrying out sampling on tank and rail tank cars and from earth and standing containers, as well as sample analysis for waste solvents and separation according to quality characteristics. Tasks ...

Tasks Production of precious metal compounds according to production instructions or batch record Providing raw and auxiliary materials, including their transport Monitoring of the plants Ensuring the operational readiness of the units and plants (if necessary, rectifying defects and faults that occur or informing superiors) Cleaning and maintenance of the plants as well as of operating equipment and tools Taking samples as part of continuous process control and carrying out release tests Collaboration in the execution of operational tests as well as in the transfer of processes from ...

A highly motivated and experienced applications specialist is sought for the analytics market. You will support customers in implementing SoloVPE systems in their labros to ensure rapid adoption of the technology. You will be providing support in Germany and across Europe. This will include supporting SoloVPE qualification and validation for GMP use in accordance with regulatory standards and customer requirements, document support and computer system validations, method development and validation, and troubleshooting with the aim of driving business expansion into new groups and customer ...

Komisjoner - zabawki (m/w/d) Gernsheim 12,43 € brutto / h + 6 € diety / dzien (netto) bez znajomosci j,niemieckiego mile widziane pary zgloszenia przyjmujemy mailowo Start: wrzesien 2022 zainteresowane osoby proszeone sa o wyslanie CV mailem

Pracownik produkcji, lekka praca Miejscowość: Selters ok. Koblencji Darmowy kurs jezyka niemieckiego online !!! Stawka:11,15€ brutto za godzinę Dieta 25€ netto dodatek na mieszkanie Dieta 10€ Netto dziennie na wyżywienie Dieta 7€ Netto dziennie na dojazdy do pracy