Dr. Shankarsheshu. R

• Handling of initial stage projects to Regulatory Approval and Commercialization for Solid Oral Dosage of Pharmaceutical units.
• Establishment of Quality Manual, Validation master Plan, Policies, Quality management system and establishing the Quality assurance controls with respective to Manufacturing, Analytical , Document issuance to get the regulatory approvals (USFDA) and to accommodate the facility for contract manufacturing.
• Planing and execution of Quality assurance and Compliance activities with the QA Team.

• Handling of Quality Management systems activities
• Handling of Planned and unplanned deviations, Quality risk assessment and Management review meetings
• Closing of change controls, Market complaints and Product recalls
• Handling of plant training activities like individual training, on the job training and cGMP training

• Expertise in Handling of initial stage projects to Regulatory Approval and Commercialization
• Preparation and review of Quality system SOPs
• Performance of vendor audits (API and Primary Packing material industries)
• Performance of Manufacturing Equipment qualifications
• (IQ, OQ and PQ)
• Preparation of Water system validation protocol and monitoring the activity
• Approval Master Batch Manufacturing records, Executed BMR / BPR and ANDA submission
• Release of commercial batches.

• Ensuring online Execution & Review of Batch records and preparing the COMs
• Preparation of validation protocols, Validation reports (cleaning validation, Equipment Qualification, process validation and packing validation )
• Review of Master Documents like SOPs/BMR/BPR
• Preparation & Review of APQRs
• Proper sampling at In-process /finished/stability/hold study for process validation batches as per approved protocols
• Ensuring in time disposition of Deviation/Incidents investigations if any
• Involving in regulatory audits
• To train juniors in respective job responsibilities and work allotment.

• Performing all IPQA Activities in manufacturing of solid orals
• Reporting of deviations/Incidents during process monitoring
• Review of Batch records
• Sampling in Process Validation activities as per the protocol
• Data collection for APQR (Annual product quality review) for all the products
• Daily activity reporting and shift management
• Maintaining SOPs for sampling procedures in related to shop floor
• Ensuring the entire documents online and ready to face audits
• Involving in internal audit and ensuring implementation of corrective action within stipulated time
• Planning for Audit preparations and exposure for regulatory audits like USFDA, MHRA, TGA, CANADA

monitoring of clinic activity during dosing for bio study.

reviewe of clincal reports after completion of the bio study

review of pharmacovigilence reports and sharing to the customers

review of consent forms, case reports, lab reports and monitoring blood sample collection as per schedule.