Sivakrishna Prasad Midde

• Leading a team of 10 people while shouldering the responsibility of day-to-day monitoring and compliance with cGMP and approved site procedures.
• Responsible for the complete management of QA operations, such as vendor/supplier management, internal and external audits, quality risk management (QRM), quality management systems (deviations, CAPAs, change controls, and trainings), in-process QA, documentation, technology transfer, and handling of QA validations.
• Developing and writing critical qualification documents for equipment, including User Requirement Specifications (URS), Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for the new facility, Utilities, and Equipment, and meeting the regulatory requirements.
• Creating and reviewing documentation related to SOPs, protocols, and other procedures. This includes the overall strategy (Validation Master Plan), specific equipment operations, process instructions, and any necessary updates or evaluations.
• Ensured compliance with all applicable laws, regulations, industry standards.
• Conducted regular meetings with staff to discuss progress and identify areas of improvement.

• Monitoring of in-process quality systems with defined standards at manufacturing areas (Diphtheria, Pertussis, Typhoid bulk intermediates), and improvement of in-process capabilities.
• Investigation of process deviations, OOS (out of specifications), and implementation of CAPA.
• Responsible for annual product quality reviews (APQR), technical complaints, deviations, CAPA, product and other change controls, batch release, technology transfer documents, product development reports (PDR), support for supplier qualification, process study protocols review, GxP documentation, and self-inspections.
• Trained subordinates for continuous improvement and to sustain a quality culture.
• Strong team player and coordination in a cross-functional setup, possessing strong leadership and the capability to constantly interact with management.
• Worked with production personnel in an advisory role to assist them with quality issues.
• Hold and manage key accounts in workflow applications like TRACKWISE (QMS software) and DMS to ensure the documentation and timely closure of the QMS documents.
• Online review of Master Formula Records (MFRs), Batch Production Records (BPRs), SOPs, aseptic process simulation/media fill protocols, laboratory control records, logbooks, and general control records for compliance.
• Actively participated in FDA, ANVISA, WHO, MCAZ, GSK, MERCK, and DCGI audits to explain the compliance status of the facility and commercial manufacturing.
• Preparation of gap assessments with respect to updated, current regulatory requirements.

• Ensuring current good manufacturing practices (cGMP) and audit compliance at the shop floor of Hepatitis B and Cholera vaccine production blocks, and assessing the unexpected events.
• Responsible for handling quality management systems (QMS), which include risk assessments, change controls, preparation of quality impact assessments, trending, and implementation changes made to approved documents.
• Hold and manage key accounts in workflow applications like PHENIX (QMS tool) and GEODE+ (Documentation tool) to ensure the documentation and timely closure of the QMS documents.
• Investigating deviations, OOS (out of specifications), and ensuring the implementation of corrective action and preventive action (CAPA).
• Performing product quality operations, such as technical complaints, deviations, CAPA, product and other change controls, batch release, support for supplier/vendor qualification, product quality review, GxP documentation, and audit support, as well as vendor qualifications and self-inspections.
• Actively participated in Installation and Operational Qualification (IOQ), Validation, and PQ activities, along with Engineering and Process Validation batches (including Cleaning Validation).
• Preparation and review of aseptic process simulation, media fill protocols, review of standard operating procedures (SOP), batch production records (BPR), protocols, master formula records, and batch manufacturing records.
• Executing the process validation and cleaning validation protocols. Identifying the gaps and initiating corrective measures through site resources.
• Conduct internal audits as per the audit/compliance team requirements, and recommend CAPAs.
• Worked with a cross-functional team in an advisory role to assist them with quality issues.
• Actively handled external audits to explain the compliance status of facility and commercial manufacturing; part of audit success, like WHO, DCGI, ANVISA (Brazil Regulatory Authority), Global Quality Audit (GQA), and customer audits.

• Worked in Tetanus Toxoid (TT) vaccine manufacturing of both upstream (fermentation) and downstream processes (purification).
• Carrying out sterile operations like Pre-Seed/Revival, seed activities, inoculation, fermentation, bulk product filtration, and respective sampling activities.
• Performing and supervising Clean-in-Place (CIP), Steam-in-Place (SIP) for major equipment, like fermenters, TFF systems, and fixed SS vessels.
• Preparing the shift schedule and manpower management as per production requirements.
• Coordinating with cross-functional departments during routine manufacturing to enhance product delivery timelines.

Facility Qualification and Equipment Validations:

• Actively participated in CQV (Commissioning, Qualification, and Validation) activities of facility and equipment for M/S MSD (Merck Sharp & Dohme Corp, USA) collaboration project “15-Valent Pneumococcal Conjugate Vaccine.”
• Actively participated in the documentation and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for the production facility and equipment.
• Involved in the qualification and validation of process equipment, such as the Federal Autoclave, BHT Solutions Glassware washer, Niro-Homogenizer, Steam in Place (SIP) module, Clean in Place (CIP) module, buffer vessels, and Tangential Flow Filtration (TFF) systems.
• CIP and SIP cycle development for buffer vessels and TFF systems.
• Collaborated with cross-functional teams to support project execution and timelines.

TT (Tetanus Toxoid) vaccine manufacturing:

• Worked in the TT-Production department of both upstream and downstream areas.
• Actively involved in the preparation of new working cell banks (WCB) and their qualifications.
• The upstream process includes the preparation of seed culture, Muller and Miller’s media, other stock solutions, and fermenter inoculation.
• Fermentation process, harvesting, detoxification with formaldehyde, and its incubation.
• Downstream processes include toxoid concentration, differential ammonium sulfate precipitation, and diafiltration using ultrafiltration (TFF) and final bulk sterile filtration.
• In-process testing methods: Gram staining for culture purity checking, and lime flocculation.
• Dynamically involved in the execution of media simulation studies and process validation activities.

HIB (Haemophilus influenzae type B) vaccine manufacturing:

• Worked in the purification of Haemophilus influenzae type B polysaccharide (PRP) and its conjugation with purified tetanus toxoid (TT) until bulk terminal filtration in dedicated production suites (cGMP areas) of the Hib (Haemophilus influenzae type B) production department.
• Activation and modification of purified PRP, and its conjugation with purified tetanus toxoid.
• Purification of the PRP-TT conjugate using gel permeation chromatography (GPC), followed by diafiltration with an ultrafiltration system (TFF), and its terminal sterile filtration.