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

Typ

📌 Senior Associate Scientist (Chennai)
🏢 Pfizer
📍 Chennai