Ľutujeme, spoločnosť ponúkajúca danú pracovnú pozíciu ukončila zverejnenie ponuky na stránke.
Ďakujeme za porozumenie.
Zobraziť podobné ponuky
Ďakujeme za porozumenie.
Zobraziť podobné ponuky
Quality and Compliance Partner (maternity leave cover)
Roche Slovensko, s. r.o.
Place of work
Bratislava
Bratislava
Contract type
full-time
full-time
Start date
ASAP
ASAP
Wage (gross)
From 1 800 EUR/monthFinal salary will depend on the seniority and experiences of the candidate
From 1 800 EUR/monthFinal salary will depend on the seniority and experiences of the candidate
Information about the position
Job description, responsibilities and duties
The Quality and Compliance Partner ensure maintenance of the local Quality Management System (QMS) and its related documents, in alliance with the Quality principles outlined in the Global Roche Good Clinical Practice (GCP) / Good Vigilance Practice (GVP) Quality Manual.
Key Activities:
● Understand and implement the GCP/GVP QMS requirements for the business and monitor progress.
● Ensure that a GCP/GVP QMS Handbook (which references the Global Roche GCP/GVP Quality Manual) is created and maintained for the Affiliate and followed by all relevant personnel.
● Ensure that an annual GCP/GVP Quality Plan is developed and monitored.
● Has oversight of the Affiliate quality risk minimization activities.
• Measure and report QMS metrics and KPIs which give performance data on Affiliate activities.
• Perform trend analysis on the KPIs for discussion at formal Affiliate management reviews.
• Serves as a key contact for all Inspection readiness processes and coordinates them
• Report quality and compliance related trends appropriately.
• Identify quality and compliance areas of improvement and provide appropriate solutions.
• Liaise with Functions to ensure compliant Vendor Management processes are in place to ensure adequate vendor oversight.
• Maintain awareness of global regulatory bodies requirements and inspection methods
• Training compliance - Liaise with training personnel to assess job role training requirements
Key Activities:
● Understand and implement the GCP/GVP QMS requirements for the business and monitor progress.
● Ensure that a GCP/GVP QMS Handbook (which references the Global Roche GCP/GVP Quality Manual) is created and maintained for the Affiliate and followed by all relevant personnel.
● Ensure that an annual GCP/GVP Quality Plan is developed and monitored.
● Has oversight of the Affiliate quality risk minimization activities.
• Measure and report QMS metrics and KPIs which give performance data on Affiliate activities.
• Perform trend analysis on the KPIs for discussion at formal Affiliate management reviews.
• Serves as a key contact for all Inspection readiness processes and coordinates them
• Report quality and compliance related trends appropriately.
• Identify quality and compliance areas of improvement and provide appropriate solutions.
• Liaise with Functions to ensure compliant Vendor Management processes are in place to ensure adequate vendor oversight.
• Maintain awareness of global regulatory bodies requirements and inspection methods
• Training compliance - Liaise with training personnel to assess job role training requirements
Employee perks, benefits
We offer:
- interesting work in one of the most innovative healthcare companies
- competitive salary and transparent remuneration system
- benefits package (13th salary, 5 vacation days in addition, contribution to pension plan, sick days, sick leave compensation, referral bonus, life and accidental insurance, meal vouchers covered by the company, 5 volunteering days per year )
- possible home office
- recreational contribution
- transportation allowance
- systematic education and career opportunities
- background of successful Swiss biotech global leader
- external development opportunities across our affiliates in other countries
- interesting work in one of the most innovative healthcare companies
- competitive salary and transparent remuneration system
- benefits package (13th salary, 5 vacation days in addition, contribution to pension plan, sick days, sick leave compensation, referral bonus, life and accidental insurance, meal vouchers covered by the company, 5 volunteering days per year )
- possible home office
- recreational contribution
- transportation allowance
- systematic education and career opportunities
- background of successful Swiss biotech global leader
- external development opportunities across our affiliates in other countries
Information about the selection process
Employment contract will be signed with personal agency on the basis of "personal leasing"
We are looking for a candidte for the temporary period (maternity leave cover)
We are looking for a candidte for the temporary period (maternity leave cover)
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Language skills
Slovak - Proficiency (C2) and English - Advanced (C1)
Personality requirements and skills
● Experience in a quality/compliance role is an advantage
● Knowledge of Quality Management
● Computer literacy in Microsoft Word, Excel, PowerPoint, Visio and Project
● Project Management skills
● Fluent in local Slovak language. Proficient in English to collaborate internally across the broader Roche enterprise is highly desired
● Structured and precise way of working
● Knowledge of Quality Management
● Computer literacy in Microsoft Word, Excel, PowerPoint, Visio and Project
● Project Management skills
● Fluent in local Slovak language. Proficient in English to collaborate internally across the broader Roche enterprise is highly desired
● Structured and precise way of working
Advertiser
Brief description of the company
At Roche, 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
https://www.youtube.com/watch?v=A4fDD8ByyrE
https://www.youtube.com/watch?v=A4fDD8ByyrE
Number of employees
100-149 employees
ID: 4118080
Dátum zverejnenia: 5.5.2023
2023-05-05
lokalita: Bratislava Pozícia: Compliance Specialist, Internal Auditor, Quality Inspector Spoločnosť: Roche Slovensko, s. r.o.
Základná zložka mzdy (brutto): 1 800 EUR/month