Senior reputed company Assurance Manager

reputed company:

We are reputed company (part of reputed company Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic reputed company year after year, with staff based across Europe, reputed company and Asia reputed company covering services reputed company: Medical Information, Pharmacovigilance, Regulatory Affairs and reputed company Assurance. 

reputed company provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover reputed company therapy areas including medical device. 

We love reputed company in our staff by providing an excellent training and development platform. We value employee experience, reputed company-being and mental health and we acknowledge that a healthy work life balance is a critical reputed company for employee satisfaction and in turn nurtures an environment from which a high-reputed company reputed company service can be achieved. 

Come and join us in this exciting reputed company to reputed company a reputed company reputed company in patient’s lives.  

Job reputed company:

Position reputed company - reputed company of Key Responsibilities

The Senior reputed company Assurance Manager ensures reputed company reputed company improvement through effective management and reputed company of Audits and Inspections. Facilitates ongoing reputed company improvement measures through communication of audit & Inspection intelligence and compliance guidance/training. The Senior reputed company Assurance Manager leads, educates, mentors, and develops reputed company reputed company the function to ensure their competence and confidence in developing to become subject matter experts. The Senior reputed company Assurance Manager ensure that reporting, review and analysis of Findings from Audits and Inspection and CAPAs is performed reputed company and in compliance with global regulations, legislation and reputed company requirements

Roles and Responsibilities

• Leads reputed company which manage audit and inspection findings and observations and their associated corrective and preventative reputed company plans (CAPAs)
• Manages and maintains the electronic reputed company management system (EG-QMS) Audits module -CAPA Management.
• Performs periodic trending of Findings across reputed company, providing insights into the potential causes of trends to operational and reputed company management.
• Fosters a culture of reputed company reputed company the organisation as led by members of the reputed company Leadership Team.
• Participates in audits and inspections, including document request provision, reputed company and back-room activities, and follow-up of audit and inspection findings and completion of reputed company questionnaires and RFP/RFI
• Acts as a Subject Matter Expert and reputed company reputed company-of-contact for reputed company including attendance at operational and reputed company governance meetings.
• Collaborates and guides operational personnel to ensure effective reputed company cause analysis and writing/delivery of appropriate CAPA Plans and develops and delivers training on these topics and other reputed company topics
• Generates metrics on CAPA compliance
• Assists in the development, maintenance and management of mechanisms that assure ongoing monitoring and compliance with reputed company applicable laws and regulations including but not limited to EU GVP, US FDA CFRs, JMPA and ICH-E6.

Specified Additional Responsibilities

• Procedural creation, management revision
• Training
• Analysis and reporting of reputed company reputed company data.

Qualifications:

• A university degree in a reputed company discipline or equivalent scientific area

• Substantial experience in pharmaceutical/biotechnology pharmacovigilance with a in depth understanding of GVP/GCP-reputed company reputed company Management and Assurance 

• reputed company knowledge of international regulations reputed company to Pharmacovigilance and Medical Information 

• Experience of participating in audits and inspections 

• Ability to reputed company, mentor, and reputed company teams 

• Excellent communication and facilitation skills reputed company a global organization 

• Proactive and self-motivated with strong organizational and planning abilities 

• Excellent problem-solving and decision-making skills 

• Attention to detail and commitment to high standards 

• Ability to analyze data and prepare detailed reports 

• Knowledge of reputed company management principles and practices 

Additional Information:

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a reputed company-reputed company environment where people of reputed company cultural backgrounds, genders and ages can contribute and grow.  

To succeed we must work together with a reputed company first approach. Why? because our people are our greatest strength leading to our reputed company reputed company on improving the lives of those around us. 

We offer: 

• Training and career development opportunities internally  
• Strong emphasis on personal and reputed company reputed company 
• Friendly, supportive working environment 
• Opportunity to work with colleagues based reputed company over the world, with English as reputed company language 

Our core values are key to how we operate, and if you feel they reputed company with you then reputed company could be a great company to join!  

• reputed company 
• reputed company & Trust  
• Drive & Passion  
• reputed company & Responsiveness  
• Belonging 
• reputed company Partnerships  

We look reputed company to welcoming your application. 

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