Senior QA Specialist

Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.

In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 47 countries, employing about 45.000 staff.

Position Summary:

This role supports Quality Assurance operations by ensuring compliance with regulatory requirements, corporate quality standards, and data integrity expectations. Responsibilities include

Coordinating and documenting training for new employees on electronic laboratory systems (ELN, LIMS), Quality Management Systems (QMS), and documentation practices

Supporting the continuous improvement of the Eurofins Quality System through review of regulatory updates, inspection findings, warning letters, and industry trend

Performing QA review and release of analytical reports

Assisting with the preparation of audit responses and regulatory correspondence

Providing support for quality assurance, data review, and other compliance-related activities as needed to maintain operational excellence and regulatory compliance.

Essential Duties and Responsibilities:

Applies GMP/GLP in all areas of responsibility, as appropriate

Demonstrate and promote the company vision

Regular attendance and punctuality

Stay abreast with all regulatory guidance and provide updates to QA team

Completion of any QA assigned activities

On-boarding training documentation preparation

Core training of new hires which includes account set up, assigning SOPs, documentation test gradings, conducting ELN and LIMS classes, etc,

Exception / Investigation writing

Basic Minimum Qualifications (BMQ):

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.

Education/Experience (BMQ):

Master’s degree in a science-related field with at least 7-10 years of experience in Bio/Pharmaceutical drug product/substance testing with knowledge of regulatory requirements and some data review responsibilities

Experience of QA department, USP/EP compendia, laboratory software applications such as Waters Empower software, LIMS, Electronic Notebook is preferred

Abilities and/or Skills:

Honest, Dependable, Demonstrated Ability to Self-Manage

Detail Oriented, Accurate, Precise

Strong Math Skills

Strong Organizational Skills

Logical Thinking, Good Reasoning Ability

Strong communication including verbal, writing, and presentation skills

Dedication to quality, ethics, and customer service

Ability to handle personal stress

Mental and emotional stability and maturity

Motivation to excel

Should be able to sit for long periods as per role requirement

Team Lead experience