Senior Specialist Data Review - Biologics (Large molecules)

Eurofins; Bengaluru; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

Eurofins Scientific in Bengaluru, India, is seeking a Senior QA/QC Specialist to ensure that client data meets GMP/GLP standards. The role focuses on reviewing laboratory data for accuracy, clarity, and regulatory compliance, with a strong emphasis on data integrity and traceability.

You will work with analysts to resolve data issues, perform complex calculations, and support SOP updates. Proficiency with Excel and laboratory software like LIMS is valued, as is the ability to communicate

Qualifications

• Master's in a science field with 15–17 years in bio/pharma testing.
• Experience with analytical methods (ELISA, PCR, flow cytometry, proteomics).
• Knowledge of USP/EP and LIMS/Electronic Notebook preferred.

Responsibilities

• Review laboratory data for accuracy, clarity, and GMP/GLP compliance.
• Verify data quality and defendability; coordinate with analysts.
• Provide QA/QC guidance and training; update SOPs as needed.
• Communicate findings to internal clients and discuss rework.

Skills

Self-motivation

Attention to detail

Communication skills

Learn quickly

Multitasking

Computer literacy

Organizational skills

Science background

Math skills

Logical thinking

Education

Master's degree in science

Tools

LIMS

Electronic Notebook

Job description

Company Description

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing.

Job Description

Position Summary: Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations

Essential Duties And Responsibilities

• Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
• Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, compound evaluation and other subjective review based on testing performed; perform complex calculations to verify results
• Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology
• May serve as technical advisor for analysts with regard to QA/QC of data
• Diagnose problems; solve simple problems, and suggest solution to complete problems in professional area
• Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employees
• Use MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulas
• Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns
• Conducts all activities in a safe and efficient manner
• Attention to details
• Works in collaboration
• Performs other duties as assigned
• Applies GMP/GLP in all areas of responsibility, as appropriate
• Demonstrate and promote the company vision
• Regular attendance and punctuality
• Read and understand analytical procedures

Qualifications

Education/Experience (BMQ: Master's degree in a science-related field with 15-17 years of experience in Bio/Pharmaceutical drug product/substance testing with knowledge of regulatory requirements.

Theoretical / Practical experience with analytical techniques such as Ligand binding assays, ELISA, Gel electrophoresis, Proteomics, Flow Cytometry, TEM, PCR, cell culture and cell-based assays (such as reporter gene, cell signaling, and cell proliferation). etc. Knowledge of USP/EP compendia, and laboratory software applications such as LIMS, Electronic Notebook is preferred.

Additional Information

Key Candidate Attributes

• Self-motivation; excellent quality of work and attention to detail
• Ability to communicate effectively with coworkers and internal/external clients
• Ability to learn new tasks quickly and to move easily from task to task
• Ability to handle prioritization and multiple tasks simultaneously
• Ability to use a personal computer and learn necessary programs
• Good communication skills (oral and written)
• Organizational ability and good judgement
• Science background/education and/or laboratory experience
• Strong Math Skills
• Logical Thinking, Good Reasoning AbilityMotivation to excel
• Coaching/mentoring of peers