QA specialist Serialization and automation

QA specialist Serialization and automation (F/H/X)

Permanent Job

As a Global QA Specialist, you’ll act as the Quality Representative for 2 international programs within a pharmaceutical manufacturing environment.

The first program focuses on upgrading and consolidating serialization systems, implementing regulatory changes, and establishing a single global set of serialization procedures to replace existing site-level documentation.

The second program involves the definition and implementation of a new automation integration layer, Manufacturing Digital Connect. You’ll assess its quality impact, define global Quality requirements, and support the project as its documentation and governance model develop.

You’ll work closely with Global Quality, IT and Digital teams, Regulatory Affairs, Manufacturing, Operations, commercial and Marketing Authorisation Holder stakeholders, as well as local site representatives.

Your missions

• Act as the Global Quality SME and primary QA contact for the serialization and Manufacturing Digital Connect programs.
• Lead the creation and implementation of a consolidated global serialization SOP suite replacing local procedures.
• Translate EU FMD, EMVS/EMVO, US DSCSA, China NMPA, and other regulatory requirements into global procedures and site controls.
• Assess the quality impact of the Manufacturing Digital Connect automation layer and define its GxP and data integrity requirements.
• Lead SOP reviews, change controls, risk assessments, deviation follow-up, and quality action plans.
• Coordinate training and competency activities for QA and Operations teams.
• Maintain inspection-ready documentation, provide clear project updates, and coordinate with Global Quality, IT, Regulatory Affairs, Manufacturing, Operations, and commercial stakeholders.

Your profile

• Bachelor’s or master’s degree in Pharmacy, Life Sciences, Engineering, or a comparable field.
• At least 8 years of experience in Quality within pharmaceutical or biotech manufacturing.
• At least 3 years of experience with global serialization, track-and-trace, or similar compliance programs.
• Hands‑on experience writing and implementing global GxP SOPs and work instructions.
• Good knowledge of cGMP, data integrity, quality risk management, and change control.
• Practical understanding of serialization systems, pharmaceutical regulations, and national traceability models.
• Strong stakeholder management and communication skills, with fluency in English. Dutch is a plus.

What we offer

Joining Amaris means working in an environment where your performance supports your career progression.

Projects with substance
Our projects last 18 months on average and involve major accounts such as Orange, Sanofi, SNCF, and CMA-CGM. You’ll work on assignments where your experience has a direct impact on project delivery and product quality.

Support from your manager and HR
Each manager supports up to 18 consultants. You’ll have regular project check-ins and a direct exchange with HR every month through Express Yourself. Our teams have an average tenure of 3.3 years.

Career progression
70% of our managers started in entry-level positions. Career development is based on skills, performance, and the opportunities you take. Functional mobility across 4 areas of expertise and international mobility across 60+ countries are actively encouraged.

Learning and technology
You’ll have access to 250+ training modules, fully funded Microsoft certifications, and 291 AI agents developed in‑house. We support continuous learning throughout your career.

Social and environmental commitments
Our commitments include an SBTi carbon reduction roadmap, a target of 34.3% women in management by 2029, and social engagement through We Care Together.

Health insurance, remote work, meal vouchers, a time savings account, and a referral bonus are also available. We’ll discuss the full benefits package during the recruitment process.

Amaris Consulting is proud to be an equal‑opportunity workplace. We’re committed to building a diverse and inclusive working environment. We welcome applications from all qualified candidates, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or any other characteristic.

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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: Info