Experience: Master’s degree in chemistry/ pharmacy with 8-10 years of experience in Analytical Method Transfer / Validation executions in Quality control Laboratory and Quality Review of sterile dosage manufacturing facility.

Core Competencies

Analytical Method Validation/Transfers/VerificationChange Management processRisk assessments principles and toolsQualification of lab equipment’sRegulatory requirements & Compendial ChangesStability Management

Technical Skills

Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography),GC,IC, ICP-MS techniquesQualified in multiple analytical techniques(HPLC-with Empower, GC, IC, ICP-MS, Potentiometry, UV‑Vis, FTIR, Karl Fischer, AAS, XRF, NIR and pH meters)Demonstrated technical skills in method validation and testingHaving Capability to understand the Compendial methods and Conduct analytical method validation in accordance with ICH Q2 (R1/R2), USP, and EP standards.Interpretation of analytical systems generates data against the procedure requirements.Having capability to assess the test method requirements against USP, EP, BP, and JP requirements for New Product Introduction (NPI).Review of document analytical method verification and method transfer activities.Demonstrate knowledge of ICH Q9 (Quality Risk Management) and apply risk‑based principles for identifying, assessing, controlling, communicating, and reviewing quality risks throughout the product lifecycle.Perform identification, assay, purity, and related analytical tests using validated methods.Having Knowledge on assessment of Elemental Impurities, Nitrosamine impurities, Extractable & Leachable and its guideline requirements.Knowledge in validation principles and practices related to the Process validation, cleaning validation, Analytical Method validation, Water system, HVAC system, Equipment & Utility Qualifications.Knowledge of various Quality tools required for investigationsTechnical Writing- Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed to be understood by any level of organizationKnowledge in change control assessmentBasic idea on manufacturing operations, validation and engineering functionsExperience in handling Regulatory agency inspections

Behavioral/Any Other Skills

Interpersonal Skills: Effective communication with all colleagues from different levels and builds constructive and effective relationshipManagerial Skills: Persistent approach to resolving issues, Effective situation handling capabilities, strong time management skills.Acts Decisively: Makes decision in a timely manner based on available informationGrows Self: Identify Individual development needs and create a plan and work towards achieving those objectivesSelf-accountable & Proactive approachStrong scientific and analytical thinkingExcellent review and documentation skillsRegulatory and GMP compliance mindsetInvestigation and problem-solving capabilitiesCross-functional collaborationLeadership and mentoring skillsAttention to detail and data integrity focusEffective communication and stakeholder management

  
Work Location Assignment: On Premise

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Quality Assurance and Control