Nazeer Mohammad Email and Phone Number

• Supervise production on the shop floor and track the formulation projects progress.• Performs Computerized system validation (CSV) and CQV and review the documents for effective implementation of GxP.• Maintain and service OSD equipment on the shop floor• Documenting the validation packages including URS, ERES, risk assessment, Traceability matrix, Validation plan, Validation summary report, and participates in establishment of new SOPs.• Implementing and maintaining robust Quality Management Systems (QMS) with strong knowledge base of regulatory guidelines such as 21 CFR, GAMP 5, and EU Annex 11

• Handles all embedded systems that include IPC and SCADA.• Assist the Formulation team by scheduling and arranging process areas as needed.• Strictly adhere to GMP, GDP, GLP, and HSE guidelines• Collaborate with vendors and cross-functional teams to restrict projects hampering.• Play a role in equipment qualifications (IQ, OQ, PQ) and document preparation.• Support team members in MES integration efforts.

• Proficient in operating the Compression Machine• Collaborates with cross-functional teams to minimize machinery downtime and enhance production.• Adheres to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) for efficient production processes• Actively contributed to the qualification of OSD manufacturing equipment equipped with embedded systems• Expertise in validating IPC through meticulous verification of all 21 CFR Part 11 compliance criteria