Quality Operations Specialist

Job Description

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. You'll have the opportunity to work within our Life Sciences team, supporting pharmaceutical manufacturing operations and ensuring the highest standards of quality and compliance.

Your missions

• Review and approve electronic batch records in accordance with GMP requirements, internal procedures, and regulatory standards.
• Identify discrepancies, documentation errors, and data integrity issues within electronic batch records.
• Collaborate with Production, Quality Assurance, and other relevant teams to investigate and resolve batch record issues.
• Support the timely review and release of manufacturing documentation.
• Conduct internal reviews or audits of electronic batch records and document findings.
• Support deviation investigations, corrective and preventive actions, and documentation follow-up when required.
• Provide guidance and training to relevant personnel on good documentation practices and electronic recordkeeping requirements.
• Contribute to continuous improvement initiatives related to batch record review and quality processes.
• Maintain electronic record management systems and ensure compliance with data integrity principles.

Your profile

• Experience working with electronic batch records or electronic document management systems.
• Knowledge of GMP, good documentation practices, data integrity principles, and regulatory requirements within the pharmaceutical industry.
• Academic background: Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Life Sciences, or another relevant discipline.
• English fluent. Another language is a plus.
• You demonstrate strong attention to detail, analytical skills, and the ability to identify documentation discrepancies and follow issues through to resolution.
• You demonstrate strong communication and stakeholder management skills.
• You are comfortable working collaboratively with Production, Quality, and cross-functional teams.

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.).
• At Mantu, sustainability is part of everything we do. You'll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you'll be empowered to design and lead projects that create real social or environmental impact, with the company's full support.

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 is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 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!