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Sr Specialist - Msat Gcc

6-8 years
Not Disclosed
10 April 11, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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