QUALITY ASSURANCE COMPLIANCE EXPERT
Would you like to start a new professional adventure as a Quality Compliance & LIMS Specialist in one of our opportunities in the Life Sciences industry in Latina (fully onsite position) ?
Define and maintain analytical specifications in the LIMS for GMP raw materials, intermediates and manufactured products.
Work with QC, QA, Manufacturing and client teams to collect requirements and translate them into LIMS records.
Implement raw material analytical testing reduction programmes in the LIMS.
Review analytical methods, tests, acceptance criteria and related documentation.
Support change controls, data reviews and GMP documentation activities.
Degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biotechnology or a related scientific field, or equivalent experience.
At least 2 years of experience in LIMS-related activities in GMP pharmaceutical environment.
Knowledge of LIMS, EU-GMP, 21 CFR Part 210 and 211, ICH guidelines and European or United States Pharmacopoeias.
Good knowledge of English at B2 level or above. Italian: native or C2 level.
Ability to work with QC, QA, Manufacturing and client teams, with strong attention to detail.
Previous experience in cleaning validation, stability studies, analytical method validation, raw material testing programmes, pharmacopoeial assessments or pharmaceutical CDMO environments would be a plus.
An international community bringing together more than 110 nationalities.
A solid training system with an internal Academy and available learning modules.
A strong commitment to well-being and work-life balance.
Local benefits in Italy:
Flexible working options according to project requirements and company policy.
Health insurance and well-being programmes, where applicable.
Gross Annual Salary (Range: EUR 24,000 – EUR 36,000).
During the recruitment process, we won’t ask for information about your current or previous salary.
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.
Trust: trust is the foundation of our relationships and enables us to promote freedom of expression, creativity and new ideas.
Performance: it guides us in our continuous improvement and in our drive to achieve concrete results.
With your application, you may have the opportunity to join a company that supports its partners in the Pharmaceutical, Biotechnology and Medical Device sectors, with activities covering Quality Control, Quality Assurance, GMP compliance, analytical and process validation, regulatory support, manufacturing excellence and R&D.;
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.
Amaris Consulting 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.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. Brief Call : 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!
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. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
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Define and maintain analytical specifications in the LIMS for GMP raw materials, intermediates and manufactured products.
Work with QC, QA, Manufacturing and client teams to collect requirements and translate them into LIMS records.
Implement raw material analytical testing reduction programmes in the LIMS.
Review analytical methods, tests, acceptance criteria and related documentation.
Support change controls, data reviews and GMP documentation activities.
Degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biotechnology or a related scientific field, or equivalent experience.
At least 2 years of experience in LIMS-related activities in GMP pharmaceutical environment.
Knowledge of LIMS, EU-GMP, 21 CFR Part 210 and 211, ICH guidelines and European or United States Pharmacopoeias.
Good knowledge of English at B2 level or above. Italian: native or C2 level.
Ability to work with QC, QA, Manufacturing and client teams, with strong attention to detail.
Previous experience in cleaning validation, stability studies, analytical method validation, raw material testing programmes, pharmacopoeial assessments or pharmaceutical CDMO environments would be a plus.
An international community bringing together more than 110 nationalities.
A solid training system with an internal Academy and available learning modules.
A strong commitment to well-being and work-life balance.
Local benefits in Italy:
Flexible working options according to project requirements and company policy.
Health insurance and well-being programmes, where applicable.
Gross Annual Salary (Range: EUR 24,000 – EUR 36,000).
During the recruitment process, we won’t ask for information about your current or previous salary.
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.
Trust: trust is the foundation of our relationships and enables us to promote freedom of expression, creativity and new ideas.
Performance: it guides us in our continuous improvement and in our drive to achieve concrete results.
With your application, you may have the opportunity to join a company that supports its partners in the Pharmaceutical, Biotechnology and Medical Device sectors, with activities covering Quality Control, Quality Assurance, GMP compliance, analytical and process validation, regulatory support, manufacturing excellence and R&D.;
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.
Amaris Consulting 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.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. Brief Call : 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!
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. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
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