Medi Srinivas

Tech transferred the new drug products of Multitope Protein/Peptide SARS-CoV-2 Vaccine and Pneumococcal
Conjugative Vaccine-(15valent-Adsorbed).
Manufacturing process developed for Multitope Protein/Peptide SARS-CoV-2 Vaccine and Pneumococcal
Conjugative Vaccine-(15valent-Adsorbed).
Manufacturing process validated for Multitope Protein/Peptide SARS-CoV-2 Vaccine and Pneumococcal
Conjugative Vaccine-(15valent-Adsorbed).
Responsible to qualifying the new facility and equipments for manufacturing of bacterial and viral
vaccines in commercial scale.
Effectively involved in manufacturing of Pentavalent vaccine, Inactivated Polio vaccine, Multitope
Protein/Peptide SARS-CoV-2 Vaccine and Pneumococcal Conjugative Vaccine-(15valent-Adsorbed).
Assigns daily duties and tasks to all team members and ensures execution of manufacturing&Filling activities in strict accordance with production batch records and standard operating
procedures.
Preparation and revision of production related documents like MFR, BMRs, SOPs and Protocols.
Preparation of Project related documents like URS, Impact assessments, FAT and SAT
checklists.
Participated in FAT for Production related equipments (Vial Washing, Vial Filling, Vial
Sealing, Depyrogenating tunnel, Autoclave, Lyophilizer and Manufacturing vessels)
Handling the Quality Management System i.e., Initiations of incidents, Deviations, Change
Controls, CAPAs through Metric stream.
Spearheading efforts across handling the entire spectrum of functions pertaining to production blending
and filling activities and control thereby ensuring strict adherence to the time schedule, quality
standards, and total productivity maintenance whilst achieving pre-set production target.
Providing direction and oversight for the shop floor and is accountable to ensure the highest safety and
quality standards are maintained. Ensuring that all associates have what they need to complete their
jobs safely.
Ensuring the manufacturing facility and equipment within their area of responsibility is properly
maintained as well as verifying the continued validated state of all equipment and processes within
their assigned area of responsibility.
Hold credentials of achieving professional excellence in monitoring production operations, process
rationalization manufacturing flow harmonization, and bottleneck & defect identification for improving
operational efficiency
Proven abilities in managing various quality standards and routinely meeting production schedules and
deploying process improvement strategies

Responsible for Manufacturing of bacterial and viral vaccines (Inactivated Polio Vaccine,Pentavalent, Measles and Rubella Vaccine) 
Ensuring GMP and GDP is followed at all levels of manufacturing and relevent activities.
Supervise production operations and ensure the production plan is achieved with respect to
quality,quantity,timelines,performance KPIs and HSE standards.
Assigns daily duties and tasks to all team members and ensures execution of manufacturing& Filling activities in
strict accordance with production batch records and standard operating procedures and cGMP.
Responsible for prepare and review of SOPs batch production records and relevant documents per training
manufacturing and filling area.
Handling and operation of formulation and filling related all equipments as per SOP.
Execution of batch manufacturing and filling as per BMR.
Carryout all quality checks/line clearance in formulation and filling area
Ensure the online documentation in working are with all necessary supporting documents to comply with
manufacturing records
Act as point of contact for internal and external audit preparations.
Ensure continuous improvement of industrial performance in manufacturing and filling area.
Simplify ways of working and establish low hierarchy.
In-line with APU concept take decision in given boundaries to meet business requirement.
Train the staff on production operations as per sanofi group strategy.
Prepare the team for variuos regulatory inspections/audits and GMP complaince.To identify correct and promptly report unsafe conditions,behaviours or potentially situations.
To animate a strong proactive culture oriented towards promoting positive behaviour at all times .
Responsible for timely execution and documenation of validation and other relavent activities.
Following clean room practices and responsible for ensuring clean room practices followed by others as per
defined procedures.
Responsible for following and implementation of sterility assurance practices and measures.
Escalates production floor issues related to personnel, safety, procedures, materials, process, equipment,
automation, utilities, and/or information systems to production management and/or appropriate functional
areaareas

As per schedule given by the HOD planning and making arrangements for all work related activities
Job distribution amongst the plant operators &monitoring the work progress
Handling of Manpower and effective utilization
Preparation of URS, SOPs, Risk assessments of the equipments and the process etc.
Preparation of FAT and SAT checklists and Preparation of MOM and reviewing of executed protocols.
Preparation FAT and SAT documents and went for the Pre-FAT and FAT of Snowbell isolator technology of vial
Liquid and lyo line (vial washer, Tunnel, filler ,sealer,lyo loading and unloading systems) LSI (Lyophilizers),
Pharmalab (PSG,WFIG,Autoclave) and Adam fabriwerk (Comounding and filtration vessels ).
Preparation of SAT checklist and conducting minutes of meeting with the vendors.
Reviewing Design Qualification of vendors document as per match the URS.
Handling of third party vendors and indenting production consumables and accessories.
Actively involving in the discussions of the vendors for procurement of the production equipments and
consumables.
Identification and maintenance of primary/raw material stock and procuring as per planning of trials
Execution validation of Total line Equipment IQ, OQ and PQ.
Preparation of SOPs, SOIs and SCPs for the processing related and for the Equipments
Day to day compliance verification in the compounding preparation and filtration activities.
Operation of CIP/SIP cycles to Mixing and Filling vessels.
Performing Integrity tests for the product filters & Vent filters of critical manufacturing equipments.
Ensuring the batch is manufactured as per the specified production plan meeting all the CGMP Requirements.
Ensuring the manufacturing prepared for line clearance at each manufacturing stage and performing in process
checks as per SOP and Batch record instructions.
Responsible for notification and handling of breakdown during batch manufacturing process.
Responsible for ensuring all the manufacturing Instruments/equipments are periodically calibrated and
undergone preventive maintenance.
Ensure in process checks are performed as per the defined frequency.
Ensure the complies of critical process parameters, To monitor the compliance of EM, Aseptic behaviour
material movement and sterility compliance during formulation and Process validation batches