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

📌 Senior Associate Scientist (Chennai)
🏢 Pfizer
📍 Chennai