Responsibilities & Duties:
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Perform all activities in compliance with GxP requirements.
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Follow quality and safety requirements in accordance with organizational policies, procedures, and regulatory guidelines.
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Ensure technical outputs align with Global Training Curricula for instrument operation, material handling, and certifications related to Quality Operations, Manufacturing, and EHS.
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Troubleshoot analytical issues related to methods and instrumentation.
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Develop and validate analytical methods using LC-MS, GCMS and ICP-MS for E&L work flow and Nitrosamine work flow support.
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Develop GTI impurity methods using LC-MS and GC-MS.
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Assess existing data packages, evaluate feasibility, and recommend remediation where needed.
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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.
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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.
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Maintain compliance with local and corporate procedures and keep all data packages audit-ready and transferable.
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Ensure formal milestone reports receive appropriate GT and ELT review to support decision-making.
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Ensure formal milestone reports receive appropriate GT and ELT review to support decision-making.
Educational Qualification & Work Experience:
Preferred 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 leachable studies. Demonstrates hands-on proficiency in HPLC, GC, GCHS, and LCMS within GMP environments, supported by strong data interpretation and technical report-writing skills.
Knowledge and skills
Technical Skills - LCMS, GCMS and wet Chemistry / HPLC and GC - Advanced
Standards, Processes and Policies - GDP / GLP/cGMP/SOP - Intermediate
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
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.
Research and Development
