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 new 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 new 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