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IT Business Analyst / Business Process Excellence / Technical Writer (Pharma, MedTech)
Arcondis Solutions s.r.o.
Place of work
Remote work
Remote work
Contract type
full-time
full-time
Start date
ASAP
ASAP
Wage (gross)
1 800 - 3 400 EUR/monthThe salary indicated is a tentative estimation and the final salary will be agreed after an interview, once we will find out more about your experience, skills and personality.
1 800 - 3 400 EUR/monthThe salary indicated is a tentative estimation and the final salary will be agreed after an interview, once we will find out more about your experience, skills and personality.
Information about the position
Job description, responsibilities and duties
Your Tasks:
• Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience.
• Create, maintain and improve tutorials, how-to guides, reference guides and explanatory material.
• Address the needs of users including software developers, product managers and end-users
• Develop documentation materials to support the administration and configuration of our customer products.
• Produce high-quality documentation for IT Infrastructure (SW Toolchain, SaaS, etc.) processes, procedures, and technical solutions in accordance with GxP regulations
• Meeting with software engineers and project manager(s) to learn about specific products or processes.
• Responsibilities for deliverables such as Business Process, User Requirements, Functional and Design Specification, Risk Analysis, Test IQ/OQ/PQ Validation protocols, Test Execution, User Manual and Training in accordance with GxP regulations.
• Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience.
• Create, maintain and improve tutorials, how-to guides, reference guides and explanatory material.
• Address the needs of users including software developers, product managers and end-users
• Develop documentation materials to support the administration and configuration of our customer products.
• Produce high-quality documentation for IT Infrastructure (SW Toolchain, SaaS, etc.) processes, procedures, and technical solutions in accordance with GxP regulations
• Meeting with software engineers and project manager(s) to learn about specific products or processes.
• Responsibilities for deliverables such as Business Process, User Requirements, Functional and Design Specification, Risk Analysis, Test IQ/OQ/PQ Validation protocols, Test Execution, User Manual and Training in accordance with GxP regulations.
Employee perks, benefits
• Company bonus (based on company financial results)
• Referral bonus depending on level of person referred
• Business mobile (also for private calls) and laptop
• Heath-/Dentalcare costs coverage (up to 250EUR/year)
• Allowance for foreign languages classes/sport and leisure activities (up to 200EUR/year)
• 3 sick days per calendar year
• 2 extra days off for your wedding
• Social events (team-buildings and team-dinners)
• Budget for trainings & certifications
• Monthly events in Kosice (Office)
• Home Office (upon agreement)
• Flexible Working Hours
• Become part of an established company with a start-up mindset (Self-organizing, flat hierarchy)
• Ice Hockey Tickets Discount (HC Kosice home games)
• Referral bonus depending on level of person referred
• Business mobile (also for private calls) and laptop
• Heath-/Dentalcare costs coverage (up to 250EUR/year)
• Allowance for foreign languages classes/sport and leisure activities (up to 200EUR/year)
• 3 sick days per calendar year
• 2 extra days off for your wedding
• Social events (team-buildings and team-dinners)
• Budget for trainings & certifications
• Monthly events in Kosice (Office)
• Home Office (upon agreement)
• Flexible Working Hours
• Become part of an established company with a start-up mindset (Self-organizing, flat hierarchy)
• Ice Hockey Tickets Discount (HC Kosice home games)
Information about the selection process
Please submit your CV in English.
Many thanks in advance for applying to Arcondis!
Many thanks in advance for applying to Arcondis!
Requirements for the employee
Candidates with education suit the position
Follow-up/Higher Professional Education
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
Educational Specialization
IT Quality and Compliance
Language skills
English - Advanced (C1)
Number of years of experience
2
Personality requirements and skills
• Project-based work experience under GxP guidelines and knowledge of those requirements & documentation practices is a big advantage
• Work experience in Pharma / MedTech industry is desirable but not a prerequisite.
• Knowledge of software systems and frameworks in embedded SW development and SW Toolchain
• Knowledge and experience in software and App development is an advantage
• Knowledge of/work experience in cGMP environment and familiarity with Technical Change Control is highly desirable
• Experience in Software as a Medical Device SaMD is an advantage
• Familiarity with maintenance processes and documentation, such as work orders, operating procedures and work instructions
• Familiarity with Agile development technologies is desirable
• Competence to work as part of a team or individually on a project, to independently evaluate situations and propose potential solutions, to manage multiple tasks and prioritize assignments to meet deadlines
• Competence to interpret quality standards for implementation
• Competence to create, update and maintain deliverables including but not limited to technical manuals, instructional material, training manual, user manual, diagrams, process flows, step by step instructions, policy and procedures, test plan and report, and product documentation for internal and external audiences
• Ability to independently gather information from subject matter experts to develop, organize and write design documents, technical drawings, product specifications, user acceptance testing, procedure manuals, technical specifications, and process documentation
• Fluency in English (C1 level minimum), a good command of German is a plus
• Work experience in Pharma / MedTech industry is desirable but not a prerequisite.
• Knowledge of software systems and frameworks in embedded SW development and SW Toolchain
• Knowledge and experience in software and App development is an advantage
• Knowledge of/work experience in cGMP environment and familiarity with Technical Change Control is highly desirable
• Experience in Software as a Medical Device SaMD is an advantage
• Familiarity with maintenance processes and documentation, such as work orders, operating procedures and work instructions
• Familiarity with Agile development technologies is desirable
• Competence to work as part of a team or individually on a project, to independently evaluate situations and propose potential solutions, to manage multiple tasks and prioritize assignments to meet deadlines
• Competence to interpret quality standards for implementation
• Competence to create, update and maintain deliverables including but not limited to technical manuals, instructional material, training manual, user manual, diagrams, process flows, step by step instructions, policy and procedures, test plan and report, and product documentation for internal and external audiences
• Ability to independently gather information from subject matter experts to develop, organize and write design documents, technical drawings, product specifications, user acceptance testing, procedure manuals, technical specifications, and process documentation
• Fluency in English (C1 level minimum), a good command of German is a plus
Advertiser
Brief description of the company
ARCONDIS is in the Top 10 of Consulting Companies in Health Care & Life Sciences in Switzerland. We are a global professional services company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory affairs.
We have been addressing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and digital transformation since 2001.
We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation.
Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We make healthcare better.
www.arcondis.com
We have been addressing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and digital transformation since 2001.
We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation.
Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We make healthcare better.
www.arcondis.com
Number of employees
150-199 employees
Contact
ID: 4238450
Dátum zverejnenia: 21.11.2022
2022-11-21
lokalita: Remote work Pozícia: Business Analyst, Compliance Specialist, IT Consultant, Process Engineer, Technical Writer Spoločnosť: Arcondis Solutions s.r.o.
Základná zložka mzdy (brutto): 1 800 EUR/month