Key Responsibilities
Engage with internal QC laboratories in the BMS network to ensure data is collated as required to support needs of the continuous analytical verification programme (CAV).
Engage with external QC laboratories to gather data in approved formats (where agreed).
Support the review of method performance monitoring data to an agreed frequency, including control charting, assessment and follow up activities with SME.
Review and perform assessment of cross site invalid rates and method performance monitoring for internal and external QC laboratories.
Support recent or updates to CAV documentation e.g SOP’s, method performance monitoring reports, master plans, dashboards.
Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), JMP, data management software (e.g. Power BI), visualization software for trending etc.
Support generation of recent or revised control limits to support the method performance monitoring programme.
Collate data to support the End-to-End business review process.




Support other ad hoc requests for data.
Support communication of risks at Tier 1 meetings
Support process improvement initiatives within the CAV programme
Support automation activities identified to be appropriate for the CAV programme

Qualifications & Experience

Education:
Minimum of a Bachelor’s degree in a life science field
5+ years experience in the Biopharm/Pharmaceutical industry with cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT)
Strong working knowledge and understanding of laboratory analytical testing methods and pharmaceutical manufacturing.
Robust knowledge of QC trending guidelines, directives and associated policies.
A thorough knowledge of cGMP regulations as referenced in key regulations such as The Code of Federal Regulations (21CFR), EMA Eudralex, USP and their specif

📌 Analytical Trending Scientist Hyderabad
🏢 Recruise
📍 Hyderabad