Roles and Responsibilities:
1.1 Compliance and Quality
Perform all activities in compliance with GxP requirements.
Follow quality and safety requirements in accordance with organizational policies, procedures, and regulatory guidelines.
Ensure technical outputs align with Global Training Curricula for instrument operation, material handling, and certifications related to Quality Operations, Manufacturing, and EHS.
1.2 Analytical Development and Troubleshooting
Troubleshoot analytical issues related to methods and instrumentation.
Develop and validate analytical methods using LC-MS, GCMS and ICP-MS for E&L; work flow and Nitrosamine work flow support.
Develop GTI impurity methods using LC-MS and GC-MS.
Assess existing data packages, evaluate feasibility, and recommend remediation where needed.
Has robust knowledge of USP, PQRI, and BPOG guidelines for SUS and MUS systems, along with expertise in writing non-laboratory, paper-based assessment reports for packaging commodities.
1.3 Documentation, Governance, and Review




Work with Quality Assurance and cross-functional teams to support consistent and disciplined execution of the LIR/ER/CAPA quality system, ensuring assigned tasks are complete and thorough.
Maintain compliance with local and corporate procedures and keep all data packages audit-ready and transferable.
Ensure formal milestone reports receive appropriate GT and ELT review to support decision-making.
1.4 Cross-Functional Coordination
Coordinate with cross-functional teams to ensure timely execution and resolution of deliverables against target milestones

Knowledge and Skills:

Technical Skills
LCMS, GCMS and wet Chemistry
Must have HPLC and GC
Standards, Processes and Policies
GDP
GLP
cGMP
SOP

Behavioral/Any Other Skills

Think Big,Speak up,
Be decisive
Focus on what matters
Agree who does what
Measure
Outcomes
Be inclusive
Act with integrity
Take pride
Recognize one another

Qualification:
Master’s in chemistry/pharmacy/Ph.D

Type of Experience:
Brings 5–7

📌 Senior Associate Scientist (Chennai)
🏢 Pfizer
📍 Chennai