Qa Associate - Small Molecules Area | Italy Based

QA Associate - Small Molecules Area | Italy based Latina Permanent Job The Pharmaceutical world is waiting for you!We are currently seeking a qualified and experienced Quality Assurance Associate, based in Italy, with a minimum of 3 years of experience in Quality or Operations pharmaceutical departments, to provide QA support to the Account Owner for External Manufacturers in the EMEA region. The selected candidate will be responsible for assisting in the development of corrective action plans, monitoring implementation, developing, writing and implementing quality procedures, providing QA support for improvement of existing manufacturing processes, contributing to the overall development, implementation and execution of quality systems in support of the manufacture of pharmaceutical products, supporting investigations, change control, collecting data, analyzing trends, and preparing reports as required. What will you do? Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time. Monitor trends, identify issues, recommend and implement appropriate actions. Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues. Coordinate and provide concurrences on deviations, complaints, change controls and CAPAs. Assist with regulatory inspections and provide follow up on regulatory commitments. Manage the generation and review of Quality Agreements. Apply cGMP regulations and other international requirements to all aspects of the position. Coordinate change control documentation and approval process. Provide Quality oversight. Interface with other functions (Operations, Planning, Technical Operations, etc) in the support of External Supply Integration. Support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and international manufacturing. ? What do we require? Bachelor's or Master's degree in either life science discipline, e.g. Chemistry, Pharmacy,Microbiolog, Biology or Biotechnology. Minimum of 3 years of experience in Quality or Operations departments. Advanced proficiency in English (Level C1), with the ability to communicate clearly and effectively in both written and spoken forms. Excellent written and verbal communications skills. Detail-oriented with strong analytical and problem-solving skills. Proficient in Microsoft Office Suite and experience with electronic quality management systems (eQMS). ? What do we offer? Work by objectives with quarterly monitoring. Educational and technical growth path. Lunch vouchers of €8 per working day. Free access to Mantu Academy platform with more than 500 courses. Psychological counseling. Our ideal candidate identifies with these values: Pioneer Spirit : desire to explore new technologies, ideas and skills to build a more sustainable world. Care : commitment to promoting diversity, meritocracy, and environmental protection for a better future. Performance : constant ambition to achieve excellence through creativity, innovation and technology. Trust : trust is a pillar of progress, driving freedom, creativity and innovation. Independence : independence is the basis for realizing a prosperous and agile future. Amaris Consulting is an industry-leading Top Employer 2024 -certified company that supports its partners in the main areas for Pharma and Biomed Industries in Quality, Laboratories, R&D and Production. Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics. Who are we? Job descriptionThe Pharmaceutical world is waiting for you!We are currently seeking a qualified and experienced Quality Assurance Associate, based in Italy, with a minimum of 3 years of experience in Quality or Operations pharmaceutical departments, to provide QA support to the Account Owner for External Manufacturers in the EMEA region. The selected candidate will be responsible for assisting in the development of corrective action plans, monitoring implementation, developing, writing and implementing quality procedures, providing QA support for improvement of existing manufacturing processes, contributing to the overall development, implementation and execution of quality systems in support of the manufacture of pharmaceutical products, supporting investigations, change control, collecting data, analyzing trends, and preparing reports as required. What will you do? Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time. Monitor trends, identify issues, recommend and implement appropriate actions. Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues. Coordinate and provide concurrences on deviations, complaints, change controls and CAPAs. Assist with regulatory inspections and provide follow up on regulatory commitments. Manage the generation and review of Quality Agreements. Apply cGMP regulations and other international requirements to all aspects of the position. Coordinate change control documentation and approval process. Provide Quality oversight. Interface with other functions (Operations, Planning, Technical Operations, etc) in the support of External Supply Integration. Support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and international manufacturing. ? What do we require? Bachelor's or Master's degree in either life science discipline, e.g. Chemistry, Pharmacy,Microbiolog, Biology or Biotechnology. Minimum of 3 years of experience in Quality or Operations departments. Advanced proficiency in English (Level C1), with the ability to communicate clearly and effectively in both written and spoken forms. Excellent written and verbal communications skills. Detail-oriented with strong analytical and problem-solving skills. Proficient in Microsoft Office Suite and experience with electronic quality management systems (eQMS). ? What do we offer? Work by objectives with quarterly monitoring. Educational and technical growth path. Competitive salary Inclusive work climate. Lunch vouchers of €8 per working day. Free access to Mantu Academy platform with more than 500 courses. Psychological counseling. Our ideal candidate identifies with these values: Pioneer Spirit : desire to explore new technologies, ideas and skills to build a more sustainable world. Care : commitment to promoting diversity, meritocracy, and environmental protection for a better future. Performance : constant ambition to achieve excellence through creativity, innovation and technology. Trust : trust is a pillar of progress, driving freedom, creativity and innovation. Independence : independence is the basis for realizing a prosperous and agile future. Amaris Consulting is an industry-leading Top Employer 2024 -certified company that supports its partners in the main areas for Pharma and Biomed Industries in Quality, Laboratories, R&D and Production. Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics. Who are we?Amaris Consulting isan independent technologyconsulting 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 of7500 people spread across 5 continents and more than 60countries. 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.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like: Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. 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!Case study: 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. As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.We look forward to meeting you! #J-18808-Ljbffr