Perform GxP-compliant analytical development, troubleshooting, and method validation for extractables/leachables and nitrosamine workflows using LC-MS, GC-MS, ICP-MS, HPLC and GC. Maintain audit-ready data packages, support QA and CAPA processes, produce technical reports, and coordinate cross-functional teams to meet milestones.
Roles and Responsibilities:
1.1 Compliance and Quality
1.2 Analytical Development and Troubleshooting
1.3 Documentation, Governance, and Review
1.4 Cross-Functional Coordination
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 years of experience in Analytical Research and Development, with strong expertise in nitrosamine workflow support and extractables and leachables studies. Demonstrates hands-on proficiency in HPLC, GC, GCHS, and LCMS within GMP environments, supported by strong data interpretation and technical report-writing skills.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Research and Development
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 strong 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 years of experience in Analytical Research and Development, with strong expertise in nitrosamine workflow support and extractables and leachables studies. Demonstrates hands-on proficiency in HPLC, GC, GCHS, and LCMS within GMP environments, supported by strong data interpretation and technical report-writing skills.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Research and Development
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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