Quality Compliance LIMS Specialist

Amaris Consulting; Latina; On-site; EUR 24,000 - 36,000; Full time

Benefits offered by this job

Health insurance

Well-being programmes

Internal Academy training

Job summary

Amaris Consulting is seeking a Quality Compliance & LIMS Specialist for an onsite role in Latina, Italy. The successful candidate will define and maintain LIMS specifications for GMP materials, collaborate with QC/QA/manufacturing and customers, and support GMP documentation and validation activities.

The ideal candidate holds a science degree and has at least 2 years of LIMS experience in GMP pharma, with strong English (B2+) and Italian (C2) proficiency.

Qualifications

• 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.

Responsibilities

• 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.
• Prepare and update analytical specifications related to cleaning validation activities.
• Implement raw material analytical testing reduction programmes in the LIMS.
• Set up and maintain stability study plans in the LIMS.
• Assess raw material requirements against applicable pharmacopoeial monographs.
• Review analytical methods, tests, acceptance criteria and related documentation.
• Support change controls, data reviews and GMP documentation activities.

Education

Bachelor's degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biotechnology or a related scientific field, or equivalent experience

Tools

LIMS

Job description

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.
• Prepare and update analytical specifications related to cleaning validation activities.
• Implement raw material analytical testing reduction programmes in the LIMS.
• Set up and maintain stability study plans in the LIMS.
• Assess raw material requirements against applicable pharmacopoeial monographs.
• 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.

Nice to have: Previous experience in cleaning validation, stability studies, analytical method validation, raw material testing programmes, pharmacopoeial assessments or pharmaceutical CDMO environments would be a plus.

What do we offer?

• An international community bringing together more than 110 nationalities.
• An environment where trust is central and internal growth is valued.
• A solid training system with an internal Academy and available learning modules.
• An active workplace with internal events, team building activities and dedicated initiatives.
• 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).
• The salary range will be determined using objective and gender-neutral criteria.
• During the recruitment process, we won’t ask for information about your current or previous salary.

Our 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.

The ideal person shares these values:

Boldness: our entrepreneurial spirit of adventure is what brings us together and drives our success.

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.

Commitment: we work with dedication and responsibility to meet our objectives.

Independence: Amaris Consulting belongs to those who created it and to those who develop it every day.

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.

Diversity and inclusion: 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.

Who are we?

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. 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.