Job Title: Sr Specialist - MSAT GCC
Job ID: 419397
Location: Bengaluru, India
Department: Technical
Company: GSK (GlaxoSmithKline)
Site Name: Bengaluru Luxor North Tower
Posted Date: April 8, 2025
Job Responsibilities:
Manage project documentation and meetings: agendas, minutes, Team Site, teleconferences, etc.
Develop lab mockups and commission protocols for early-stage testing.
Act as validation expert for Single Use Systems (SUS):
Write Design Summary Reports (DSR)
Conduct and update Failure Mode and Effect Analysis (FMEA)
Develop User Requirement Specifications (URS)
Manage Change Control (eCC) processes.
Execute Design Qualification (DQ) and Validation Master Plans (VMP).
Write and execute IOQ protocols, manage lab incidents.
Compile Validation Summary Reports (VSR).
Perform risk assessments: Chemical Compatibility (CRA), Leachable Risk (LRA), and Patient Exposure Scenarios (PES).
Oversee BCT testing for shipping validation.
Develop training packages for new technologies.
Handle Purchase Orders and component acquisition from manufacturers.
Coordinate with external labs for GMP-compliant shipping.
Track project progress, prepare weekly reports.
Manage master data creation for new items.
Support tenders and supplier management.
Review documentation from junior staff to ensure quality.
Required Skillsets:
Master’s degree in Chemistry, Biology, Chemical Engineering, or related field.
6–10 years of MSAT or related experience in pharmaceuticals or biopharma.
Knowledge of SUS validation and vaccine manufacturing.
Strong GMP and GDP knowledge.
Hands-on lab skills, flexible and adaptive mindset.
Strong writing skills for technical documents: DSR, FMEA, URS, DQ, VMP, IOQ, VSR, etc.
Excellent communication and teamwork in international matrix settings.
Scope & Function:
The MSAT team ensures safe, efficient, compliant manufacturing processes.
Supports global sites in Asia, Europe, and the US.
Focus on process optimization, validation, tech transfer, and innovation.
Inclusion Statement:
GSK promotes inclusion. If adjustments are needed during the recruitment process, contact:
📩 IN.recruitment-adjustments@gsk.com
Why GSK?
Focus on vaccines, specialty and general medicines.
Four core therapeutic areas: Infectious Diseases, HIV, Respiratory/Immunology, and Oncology.
Aims to positively impact global health and foster a thriving workplace environment.
Important Notice:
GSK does not charge any recruitment fees.
Report suspicious job ads or emails to: 📩 askus@gsk.com
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