Executive - QA
Eurofins Bengaluru, Karnataka, India
Medical and Diagnostic Laboratories · 201-500 employees
About the role
The role involves ensuring compliance with quality management systems and regulatory guidelines while managing internal and external audits. You will also oversee documentation, training programs, and corrective actions to maintain high quality standards.
What they look for
Requirements
Candidates must hold a Master's degree in Science, Pharmacy, Genetics, or Bioinformatics. A minimum of 4 years of experience in Quality Assurance is required for this position.
Full description
Company Description
Experience the power of DNA
Eurofins Genomics is part of Eurofins Scientific Group, an international provider of genomic services established around the core business lines of next generation sequencing, custom DNA sequencing, oligonucleotides, siRNA and gene synthesis. The company's main mission is focused on customer convenience and high quality services in industrial scale for the life science industries and academic research institutions around the world. Eurofins Genomics India corporate office is located in Bangalore with a 14000 sq.ft. with a state-of-the-art infrastructure having more than sixty highly qualified, trained and skilled scientific resources, production facility, data analysis par excellence expertise and quality of products and services. Our NGS projects are being delivered using advanced Illumina NextSeq500 platform, HiSeq2500, MiSeq, PacBio sequel with high performance computational infrastructure.
Eurofins Genomics India's expertise and experience in the field of genomics has helped us to gain a solid reputation as a provider of high quality DNA/RNA oligonucleotides, NGS, Gene synthesis and Sequencing services to the top life science industries, research Institutes and academic research institutions across India and covering more than 6000 customers. The laboratory and production facility has established profound know-how and proprietary protocols to cover a broad range of applications. Our production facility is ISO 9001: 2015 certified, which ensures you get the highest quality of products and services.
Eurofins Genomics India's prime goal is to provide its customers with high-quality services, accurate results in fast turnaround time. We make our best effort to exceed our customer's expectations and help them in achieving their research goals in a cost-effective and quick way.
With over 30,000 staff in over 375 laboratories across 41 countries, Eurofins Scientific is the world leader in food, environment, genomics and pharmaceutical products testing. It is also one of the global market leaders in agroscience, genomics, discovery pharmacology, and central laboratory services. In addition, Eurofins is one of the key emerging players in specialty Clinical Diagnostic testing in Europe and the USA.
Job Description
**Job Responsibilities:**
- Ensure compliance with Quality Management Systems (GxP, ISO 9001:2015, GLP & GMP guidelines) and applicable statutory, regulatory, and client requirements.
- Conduct internal audits, manage regulatory and client audits, and oversee closure of non-conformances and corrective actions.
- Develop, review, and maintain Standard Operating Procedures (SOPs) to ensure current and effective documentation.
- Manage Training, Change Management, Deviation Management, and Corrective and Preventive Actions (CAPA) programmes in compliance with regulatory requirements.
- Investigate critical non-conformances and quality incidents to determine root causes and implement preventive measures.
- Perform risk assessments across quality-related processes and implement mitigation strategies.
- Coordinate with accreditation and certification bodies to obtain and maintain ISO, GLP, and GMP certifications.
- Monitor and report Quality Key Performance Indicators (KPIs) to drive continuous improvement initiatives.
- Manage records and archival systems to ensure proper documentation retention and regulatory compliance.
- Foster a quality culture through cross-functional collaboration and stakeholder engagement.
Qualifications
Master’s in science / M pharma / Genetics / Bioinformatics or relevant.
Experience: Minimum 4 years of experience in QA.
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