QA Batch Record Review (sterile)

Amaris Consulting | Part of Mantu; Latina; On-site; EUR 24,000 - 36,000; Full time

Benefits offered by this job

International community

Internal Academy training

CSR programs

Job summary

Amaris Consulting | Part of Mantu in Italy seeks a Pharmaceutical Quality Assurance professional to ensure GMP and regulatory alignment. You will review batch records, support audits, and drive CAPA while collaborating with production, R&D and supply chain to uphold quality across processes.

The role requires 1+ year in pharma QA, strong GMP knowledge, and fluency in Italian and English, with a Master’s degree in a related field. An international environment and training are offered.

Qualifications

• 1+ year experience in Quality Assurance in pharma.
• Solid knowledge of GMP guidelines and regulatory standards.
• Experience with Batch Record Review in sterility field.

Responsibilities

• Ensure GMP compliance and regulatory standards across products.
• Perform document review and approval (batch records, SOPs, quality manuals).
• Conduct deviation analysis and CAPA implementation/monitoring.
• Support audits/regulatory inspections with prepared documentation.
• Collaborate with production, R&D and supply chain to maintain quality.
• Perform risk assessments and contribute to continuous improvement.
• Provide training on quality procedures and regulatory updates.
• Prepare and present reports on quality indicators and progress.

Skills

Quality Assurance

GMP knowledge

Regulatory standards

Analytical skills

Team collaboration

Education

Master’s degree in Pharmacy / Biotechnology / Chemistry

Job description

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.

We look forward to meeting you!

Job description

Join our team and start a new adventure in an international and dynamic environment where you will be able to fulfil your career expectations in a fast-growing organization.

Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in the pharmaceutical field, but above all being an ambassador of our organization to clients thanks to:

• Your interpersonal skills and ability to listen in order to build a strong relationship of trust with our clients and fully understand their challenges and issues.
• Your curiosity and eagerness to learn as we support over 1000 clients from all sectors worldwide.

Your missions

• Ensure compliance of pharmaceutical products with GMP and regulatory standards.
• Perform document review and approval (batch records, SOPs, quality manuals).
• Conduct deviation analysis, CAPA implementation and monitoring.
• Support audits and regulatory inspections by preparing documentation and answering queries.
• Collaborate with production, R&D and supply chain teams to guarantee quality across processes.
• Perform risk assessments and contribute to continuous improvement projects.
• Provide training to colleagues on quality procedures and regulatory updates.
• Prepare and present reports on quality indicators and project progress.

Your profile

• Experience with Quality Assurance in the pharmaceutical industry (1 year minimum).
• Knowledge of GMP guidelines and pharmaceutical regulatory standards.
• Experience with Batch Record Review in sterility field.
• Academic background: Master’s degree in Pharmacy, Biotechnology, Chemistry, or related field.
• Fluent Italian and English.
• You have strong organizational and analytical skills with attention to detail.
• You are able to adapt quickly, work in a team and maintain high-quality standards.

What we offer

• An international community bringing together 110+ different nationalities.
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities.
• A robust training system with our internal Academy and 250+ available modules.
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.).
• Gross Annual Salary (GAS): EUR 24,000- EUR 36,000 ; basic salary only, the variable component will be detailed in the offer
• Strong commitments to CSR notably through participation in our WeCare Together program.

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.