production and development of the medical devices -You will have to comply to quality standards, for example ISO 13485 and CFR 820 -You will be supervising the CAPA processes and comply with licensing requirements -You will be supporting the project team and the CIP process together with the CAPA entities
customer requirements against Quality, Time and Budget while it is also important to comply with local production requirements. In this position you are part of the Process Engineering team and you report to the Manager Advanced Process Engineering. Senior Process Engineer Miejsce pracy: Września What do we expect from you? -You have a finished degree in Mechanical Engineering / Production Automation on a ...
the company maintain appropriate processes to comply with applicable laws, regulations and company's policies and ethics. Compliance Analyst IV coordinates various compliance efforts related to internal operating practices and requirements on behalf of the compliance monitoring team. The scope of
timely decision making. You will be creating cohesive governance structure and ensure that the business operates in such a way as to align with Group policies, and to comply with any statutory and regulatory requirements. Being a Centre Director means also to lead initiatives that will help to attract
ROLE DESCRIPTION In this role you will be responsible for the validation of production processes and reports in order to ensure GMP compliance. Therefore you will need to interpret excisting production processes and data to ensure that they comply with GMP standards, client requirements
budget/forecast, supporting Business with analyses and recommendations, supporting month-end and year-end close process, ensuring quality control over financial transactions and financial reporting, manage and comply with Group procedures requirements, maintaining and strengthen internal controls, implement
infrastructure according to the Enterprise Architecture Program Charter as well as comply with GxP & FDA 21 CFR part 11. What you'll need to succeedTo be successful Candidate you must have min. 2-3 years of previous experience as Network Administrator. You must have strong experience with networks in different
a regulatory affairs director you will be responsible for implementing the regulatory strategy. RESPONSIBILITIES - Make sure that regulatory submissions comply with relevant regulations and guidelines - Be one of the leading actors in the development of the company´s strategy
Manage and comply with Group reporting requirements, Develop and document business process and accounting policies to maintain and strengthen internal controls, Additional controller and ad hoc duties as necessary, ProfileHigher education: economics, finance, accounting etc., Minimum 3 years of
the scheduling of and take notes during Investigation, Disciplinary and Grievance meetings Assist in the implementation and operation of all HR and Company Policies and Procedures Assist with updating company documents as and when necessary to ensure that documents comply with current legislation Basic Qualifications Degree in Human Resources Management or related field Previous experience as a ...
you will ensure that all factories and 3rd party manufacturers in the group comply with internal and external quality standards. You will analyse audit results and identify areas of improvement, and work together with local teams to implement improvement plans. Finally, you will make recommendations
timekeepersSubmission of timekeeper’ rates or fee offers Follow-up on approval processes E-billing Hub implementationCreation of user accounts for 22 offices (and more entities)Training users (new comers + refresher courses) on-site or via Webex or LyncCreating and updating user guides and procedures Comply with the
production of an annual plan to satisfy corporate business requirements Participation and support in production of realistic but challenging forecasts in line with corporate business requirements Comply with all regulatory and corporate business reporting deadlines Building and maintaining strong
and support in production of an annual plan to satisfy corporate business requirements • Participation and support in production of realistic but challenging forecasts in line with corporate business requirements • Comply with all regulatory and corporate business reporting deadlines • Building and
optimize the preventive maintenance plans within the plant and to comply with applicable legal (european but also non-european) regulations. This is realised by the development and execution of maintenance concepts in order to achieve an efficient productivity. You will acts as an advisor for the complete
Projects, including analyzing data, working together with CROs and animal trial labs, holding presentations. - Ensure that all products comply with legislation in new and existing markets, including the US and Asia. REQUIREMENTS - Relevant Bachelor's Degree, a Master's Degree
and Quality Training & Education comply with Corporate and Regulatory requirements. Leads a team of 6 team members of the QA team EU and is a member of the Management Team (MT) together with EU team leaders of Sales & Marketing (direct and indirect markets), Finance, Service & Logistics and Human
coordinating, supervising and organizing registrations, type testing and product tests which are necessary to the admission comply. - To support and advise on product ranges and market introductions in regulatory aspects. This includes: CE mark, MDD, FDA approval, certifications, type testing, technical file ...