Principal Data Review Specialist – Large Molecules and Microbiology

Bangalore, Karnataka
Permanent
Full-time

17 days ago

Company DescriptionEurofins 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 DescriptionPosition 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:

Leading the team of 8-10 individuals from large molecules and microbiology domain
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, 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
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

QualificationsBasic 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 10-12 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, Next gen sequencing, Flow Cytometry, TEM, PCR (qPCR, RT-PCR), cell culture (banking, maintenance & prep), water Testing, microbial limit testing, endotoxin testing, sterility testing, and environmental monitoring 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 preferredAdditional InformationKey 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 Ability
Motivation to excel
Coaching/mentoring of peers

Eurofins

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