Quality Consultant
3 giorni fa
Latina, Provincia di Latina; Lazio, Italia
Amaris Consulting | Part of Mantu
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pWould you like to start a new professional adventure as a bRegulatory Affairs Consultant /b in one of our opportunities in the bLife Sciences /b industry in bLatina (fully onsite position) ? /b /p ul liDraft and review Quality and CMC sections of regulatory dossiers, with a focus on Module 3 of the CTD. /li liPrepare and update pharmaceutical quality documentation for new marketing authorisation applications. /li liProvide technical and regulatory support to clients during new registration processes. /li liReview manufacturing, control and validation data included in regulatory submissions. /li liAssess documentation related to sterile pharmaceutical manufacturing processes. /li liCollaborate with clients, manufacturing sites, Quality teams and regulatory stakeholders. /li liDegree in Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biotechnology or a related scientific field, or equivalent experience. /li liPrevious experience in pharmaceutical Regulatory Affairs, with a focus on CMC documentation and CTD Module 3. /li liGood knowledge of English, both written and spoken. Italian native or C2 level. /li /ul pbWhat do
we offer
? /b /p ul liAn international community bringing together more than 110 nationalities. /li liA solid training system with an internal Academy and available learning modules. /li liA strong commitment to well-being and work-life balance. /li /ul pbLocal benefits in Italy: /b /p ul liFlexible working options according to project requirements and company policy. /li liHealth insurance and well-being programmes, where applicable. /li liDuring the recruitment process, we won’t ask for information about your current or previous salary. /li /ul pOur salary ranges are intentionally wide, because we hire talented minds, not “templates”. The same role can attract very different candidates, and we believe in leaving room for that. What lands within the range depends on your specific experience, skills and what you bring to the role. /p pbTrust: /b trust is the foundation of our relationships and enables us to promote freedom of expression, creativity and new ideas. /p pbPerformance: /b it guides us in our continuous improvement and in our drive to achieve concrete results. /p pWith your application, you may have the opportunity to join a company that supports its partners in the bPharmaceutical, Biotechnology and Medical Device /b sectors, with activities covering Quality Control, Quality Assurance, GMP compliance, analytical and process validation, regulatory support, manufacturing excellence and RD. /b Amaris Consulting promotes equal opportunities and assesses applications based on skills, experience and potential. We welcome qualified applications without discrimination based on gender, gender identity or expression, sexual orientation, ethnic origin, nationality, religion or belief, age, disability, marital or family status, or any other protected characteristic. /b /p pbAmaris Consulting /b is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade
- this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success. /p pAt Amaris, we strive to provide our candidates with the best possible recruitment experience. Here's what our recruitment process looks like: /p pbBrief Call /b: Our process typically begins with a brief virtual/phone conversation to get to know you We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities /p pbCase study /b: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc. /p pAs you know, every person is different and so is every role in a company. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience. /
we offer
? /b /p ul liAn international community bringing together more than 110 nationalities. /li liA solid training system with an internal Academy and available learning modules. /li liA strong commitment to well-being and work-life balance. /li /ul pbLocal benefits in Italy: /b /p ul liFlexible working options according to project requirements and company policy. /li liHealth insurance and well-being programmes, where applicable. /li liDuring the recruitment process, we won’t ask for information about your current or previous salary. /li /ul pOur salary ranges are intentionally wide, because we hire talented minds, not “templates”. The same role can attract very different candidates, and we believe in leaving room for that. What lands within the range depends on your specific experience, skills and what you bring to the role. /p pbTrust: /b trust is the foundation of our relationships and enables us to promote freedom of expression, creativity and new ideas. /p pbPerformance: /b it guides us in our continuous improvement and in our drive to achieve concrete results. /p pWith your application, you may have the opportunity to join a company that supports its partners in the bPharmaceutical, Biotechnology and Medical Device /b sectors, with activities covering Quality Control, Quality Assurance, GMP compliance, analytical and process validation, regulatory support, manufacturing excellence and RD. /b Amaris Consulting promotes equal opportunities and assesses applications based on skills, experience and potential. We welcome qualified applications without discrimination based on gender, gender identity or expression, sexual orientation, ethnic origin, nationality, religion or belief, age, disability, marital or family status, or any other protected characteristic. /b /p pbAmaris Consulting /b is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade
- this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success. /p pAt Amaris, we strive to provide our candidates with the best possible recruitment experience. Here's what our recruitment process looks like: /p pbBrief Call /b: Our process typically begins with a brief virtual/phone conversation to get to know you We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities /p pbCase study /b: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc. /p pAs you know, every person is different and so is every role in a company. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience. /