MANISH JOSHI

Job Responsibilities

• Validation, Qualification, Periodic Review, Periodic Validations.
• Vendor Qualification.
• Market Complaint Handling, Review and Investigation and Trending of market Complaints
• Initiating Mock recalls.
• FSTL (Food safety Team Leader)
• Batch Release.
• Cleaning Validation (CEHT, DEHT, Campaign Length).
• Process Validation (Preparation, Review of Protocol and Reports).
• Heating Ventilation and Air Conditioning System Qualification (Preparation, Review of Protocol and Reports).
• Product Hold Time Studies. (Preparation, Review of Protocol and Reports).
• Vendor Qualification.
• Internal Audits (Certified Internal Auditor from Intercert), Conducting Internal Audits.
• Process Verification Review. Review of Report
• Master Batch Production Review and Approval,
• Investigation Review and Preparations,
• Miscellaneous Studies Protocol preparation and execution.
• Resolving Customer Queries and Compliance against Audits and Facing Regulatory, Certification Audits and Customer Audits.
• Preparation of Site Master File, Validation Master Plan.
• Training i.e., SOP' Trainings and Scheduled Trainings.
• Change Control Review and Closures.
• CAPA Implementation and Effectiveness Checks.
• Investigation and Root Cause Analysis.
• SOP Preparation and Review.

Job Responsibilities

• PROCESS VALIDATION and Hold Time Study Protocol Preparation ,Compilation ,Execution and Review of Process Validation, Process Verification, Process Evaluation and Hold time Protocols and Reports. Sampling of Product / material at various Stages during Process and report review, coordination with IPQA, and other departments for Implementation and execution of Validation Activities.
• Sop Preparation and Imparting Training.
• Review of manufacturing documents such as BMR, BPR etc.
• Handling of QMS activities e.g., manufacturing (shop floor) investigation, CAPA monitoring and change control review for new / site transfer products.
• Preparation, Compilation, Execution and Review of Process Validation, Process Verification,
• Query Response Preparation as per Regulatory and Customer Requirement.
• Initiating Change controls.
• Sampling at various stages during Process Validation.
• Review of BMR/BPR for regulatory submissions.
• To strengthen the systems for streamlining the manufacturing operations with effective procedural implementation and document revision to meet the regulatory requirement.
• Submission of Documents for Regulatory Filings.
• Preparation of Validation Strategy.

• PROCESS VALIDATION and Hold Time Study Preparation ,Compilation ,Execution and Review of Process Validation, Process Verification, Process Evaluation and Hold time Protocols and Reports. Sampling of Product / material at various Stages during Process.
• CLEANING VALIDATION: Preparation of Protocol and Report , Swab Sampling, Wash Water Sampling.
• Handling of Observations Deviation, Investigation, etc. Initiation and closure of Observation, Event or Deviation, Investigation, completion of Action Plan.
• Review of manufacturing documents such as BMR, BPR etc. Handling of QMS activities e.g., manufacturing (shop floor) investigation, CAPA monitoring and change control review for new / site transfer products.
• To strengthen the systems for streamlining the manufacturing operations with effective procedural implementation and document revision to meet the regulatory requirement.
• n process checkup at dispensing to packing stage of tablets /capsules manufacturing.
• Calibration of IPQA Instruments
• Calibration and Verification of Analytical Balance.
• Ensure the compliance of raw material, finished product, packing material with respect to established specification.
• To assure the c- GMP and other regulatory compliance during all manufacturing activities.

• In process Quality Assurance.
• Investigation Review and Preparations.
• Product Hold Time Sampling.
• Process Validation execution, Cleaning Swab collection.
• In process checkup at dispensing to packing stage of tablets /capsules manufacturing.
• Calibration of IPQA instruments
• Calibration and Verification of Analytical Balance.
• Review of manufacturing documents such as BMR, BPR etc.
• Trending of Shop Floor Observations and Assisting in Investigation.
• Ensure the compliance of raw material, finished product, packing material with respect to established specification.
• To assure the c- GMP and other regulatory compliance during all manufacturing activities.
• Blend Sampling, Stratified Sampling. In process Sampling in Packing and Manufacturing.
• Line Clearance in Various areas.

• In process Quality Assurance.
• In process checkup at dispensing to packing stage of tablets /capsules manufacturing.
• Review of manufacturing documents such as BMR, BPR etc.
• Blend Sampling, Stratified Sampling. In process Sampling in Packing and Manufacturing.
• Line Clearance in Various areas.