Responsible to handle the team to achieve the set targets in Packaging area & maintain qualitative, quantitative as well as CGMP aspects. Knowledge of Dispensing, Sampling, Material Receiving & Issuance, SAP, Documentation.
Exposure of analysis for Finished Products, Stability Samples and Raw Materials. Having Knowledge of Analytical Method Validation, Verification and Method Transfer. Having skill for data interpretation, troubleshooting. Pharma knowledge of Solid orals and Quality process.
Audit Response writing skill, Audit handling skill. Current Guideline assessment and compliance. Gap Assessment to overall Regulatory Compliance. Proficient in risk assessment, cleaning procedure optimization. Adept at collaborating with cross-functional teams to maintain robust cleaning validation programs.
Expertise in designing, executing, and reviewing cleaning validation protocols. ensuring compliance with cGMP. EMA. and other global regulatory requirements. Specializing in stability studies, regulatory compliance, and quality assurance oversight. Managing stability programs in alignment with ICH guidelines
Topical Formulation, Semi Solid Manufacturing, Cream Ointment Gel Production, QMS, SAP, In Process Checks, Deviation Handling and CAPA, Audit readiness and documentation, Production Planning and Scheduling, Cross functional collaboration, Team Supervision, Process Optimization.