KRISHNAM RAJU

• Monitoring and supervision of Drug product process validation, APQR/PQR (Annual product quality review), continuous process verification (CPV), media fill validation, batch release, dossier support, customer support
• Preparation, review and approval of process validation protocols and reports
• Preparation, review and approval of media fill related documents
• Preparation, review and approval of annual product quality reports (APQR)
• Review and approval of continuous process verification (CPV) reports
• Ensuring batch records review and batch release process
• Review of Market complaint investigations
• SPOC (single point contact) for batch release for drug products
• Handling of CMO (contract manufacturing organization)
• SPOC (single point contact) for dossier support and agency queries like USFDA, TGA, ANVISA and other global markets
• Conducting onsite audits to the vendors and cross functional departments
• Audit faced and supported in BE (FDA 2018,2021,2023,2024) & INFARMED (2021) MHRA (2023) and other local DCA and central CDESCO and customer audits
• Tracking and on time closure all QMS action items related to IPQA support team
• Handling of launch products, new product introduction (NPI) process
• Review and CFT assessment of change controls, deviations and CAPA related to manufacturing
• Review of transit excursions for all commercial products
• Review of technology transfer documents
• Managing QMS elements such as deviations, investigations, change controls & CAPAs; preparing & reviewing quality risk assessments with respective manufacturing (Formulation) facility

• Monitored and supervised line related activities such as manufacturing, filtration, filling and sealing & visual inspection
• Prepared and reviewed department specific documents (SOPs, Protocols, Reports) as per current procedures
• Reviewed and approved documents (Batch records/incidents/investigations, change controls, CAPA as applicable) as required and or assigned by supervisor
• Performed & ensured if investigations are performed adequately in timely manner to identify the root cause, assessed the impact and necessary corrective & preventive actions
• Reviewed relevant open QMS elements (incidents, investigations, change controls, CAPAs) pertaining to the area of supervision/review and facilitate timely closure
• Ensured the relevant team members are trained & qualified for performing their key duties and job responsibilities; also ensured if relevant resources are arranged & provided for the team members to perform their duties
• Provided periodic trainings for the team members as part of knowledge building and strengthening the skill sets
• Reviewed Quality Risk Management (QRMs) with respective autoclave, filling machine, sealing machine; executed OQ and PQ with respective autoclave, tunnel, filling machine
• Managed various software such as Track-wise (Incidents, investigations, change controls, CAPA, PMSI) Documentum
• Approved & reviewed position papers/rationale which will be prepared by cross-functional departments
• Reviewed CCTV footage for specific line on periodic basis; supported various audits including USFDA (2016, 2017) & TGA (2016)

•  Review and submission of dossier documents to different markets like USA, EUROPE, MEXICO, BRAZIL, SOUTH AFRICA and ROW markets.
•  Review of Technology transfer dossier.
•  Review of master batch manufacturing records and batch packing records comparing with the executed batch manufacturing records and batch packing records.
•  Review of process validation protocols and summary reports.
•  Review of master draft BMRs and BPRs comparing with the technology transfer dossier and Standard operating procedures.
•  Review of SOP’s related to production, engineering, microbiology departments.
•  Review of packaging summary of vials, ampoules, rubber stoppers etc.
•  Preparing the query response from site level and submission to RAD.
•  Preparation of Yield and reconciliation of individual products.
•  Handling of Deviation, Change control, Non-conformance though QMS soft ware’s (Metric stream).
•  Initiation of deviations and change controls.
•  Preparation and readiness for external and internal audits.
•  Participated and explained the topics to the auditors like batch records, process validation.
•  Audits faced and supported in Aurobindo i.e. ANVISA, USFDA (2012, 2014), WHO, INFORMED (Portugal), GCC.ORION (Customer audit).

•  Routine in process checks and monitoring of filling area temperature, Humidity, LAF pressures, differential pressures in all areas.
•  Review the Batch records and media fill records and submission batch records.
•  Sampling of finished product samples and cleaning validation samples.
•  Monitoring and compilation of aseptic media fill validations.
•  Preparation of media fill validation protocols and supporting for effectiveness preparation of batch records.
•  Online monitoring and execution of submission batches and commercial batches.
•  Verification of batch records for accuracy of data and compilation.

 Handled IPQA activities during dispensing, manufacturing, washing, filling, lyophilization, Sealing, leak testing, visual inspection, labelling and packing
 Routine in process checks and monitoring of filling area temperature, Humidity, LAF pressures, differential pressures in all areas.
 Review the Batch records and media fill records and submission batch records.
 Sampling of finished product samples and cleaning validation samples.
 Exposure on optical inspection validation for visual inspectors.
 Responsible for online GMP records completion and verification.
 Monitoring and compilation of aseptic media fill validations.
 Preparation of media fill validation protocols and supporting for effectiveness preparation of BPCRs.
 Online execution of BPCRs and verification of online documentation.
 Verification of BPCR for accuracy of data and compilation