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Department NameAT-GTEL, ChennaiJob TitleSenior Associate Scientist (Chem Analytical)Global Job levelsJob Family Group: Research and DevelopmentJob Family: 093- Chemistry-AnalyticalJob Category: ResearchJob Level: R02 - Senior Associate ScientistJob Code: 602689Management Level: J050Reports toGroup LeadLocation(s)GTEL, IITM-RP.Job Summary (Summarize the primary purpose & key accountabilities of the job function.)Responsible for Analytical Method development, Method Validation, Method transfer, Investigation, Regulatory support, Routine analytical and stability study support for API, Intermediates and different DP formulations.Job Responsibilities (Indicate the primary responsibilities critical to the job function.)ROLE RESPONSIBILITIES Responsible to Perform all activities as per GxPHe should adhere both quality and safety compliance according to organizational policies/procedures and regulatory guidanceShould be able to perform trouble shooting of analytical challenges which includes method and machine.Responsible for development analytical methods and analytical method validation by UPLC, HPLC, GC, Dissolution for API, DP, Intermediate and Raw materials.Support the analytical activities of lab trial batches, feasibility batches, lab scale batches, stability batches, stability studies as per plan.Perform assessments of existing data packages, feasibilities and concluded remediation.Ensure technical output is compliant with all Global Training Curriculum for the Instrument operations, material handling and Certifications related to Quality Operations, Manufacturing and EHS.Work with the Quality Assurance and other cross functional teams to facilitate the consistent, disciplined execution of the LIR\ER\CAPA quality system ensuring the completeness and comprehensiveness of the assigned task.Ensures Compliances to local and corporate procedures and ensures all data packages are audit ready and transferable.Coordinate with cross functional teams to ensure timely execution and resolution of all Deliverable versus target milestonesQualifications/Skills: Education - Experience - Additional Requirements (Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications, and other job-related technical and managerial skills.)Requirements for all Global Job LevelsPREFERRED QUALIFICATIONSM.Sc. in Chemistry/M.PharmPREFERRED YEARS OF EXPERIENCE3 to 6 years of ExperienceTYPE OF EXPERIENCEExperience in Analytical Research and Development, possesses knowledge of oral solid dosage forms, liquids, semisolids, and API. Understand regulatory expectations and possess exceptional expertise in data interpretation and scientific outputs.Hands on experience in handling HPLC, Dissolution, UV, GC and Wet Chemistry.Organizational Relationships: (Provide the primary groups or key role(s) that this role will interact with as a regular part of the job responsibilities. Include any external interactions as appropriate.)Small Molecule TechnologyGlobal Technology & EngineeringLaunch ExcellencePfizer Manufacturing SitesExternal SupplyGlobal Supply ChainRegulatory SciencesGlobal EHSProcurementPharmaceutical Sciences Small MoleculeContract Research, Development and Manufacturing OrganizationsAcademic InstitutesNot Applicable.SupervisionNot Applicable.  Work Location Assignment: On PremisePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Research and Development#LI-PFE
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