Prince Valavara Email & Phone Number

North Ras Al Khaimah, United Arab Emirates

Ras Al-Khaimah, United Arab Emirates

>Responsible for QA oversight functions in Biotech & Sterile plants.>To ensure cGMP compliance in area (Monitoring good documentation practices, correctness of batch documents, logbooks, labels etc. / gowning attire / cleanliness / adherence to SOP's, manufacturing & packaging instruments etc. )>To perform in-process quality check activities according to SOP in Production / packaging departments in complying with cGMP principles & capture test results in batch records.>To verify line clearance / line release activities as per SOP.>To review batch manufacturing records & batch packaging records for batch release.>To prepare Annual Product Quality Review of Biotech & Sterile plants.>To assist in performing change controls & CAPA assessments using Ample Logic Software related to products / plants of Biotech & Sterile.>To support site QA lead performing product quality related investigations & risk assessments.>Review of all technical department SOP's & documents for adequacy of procedure contents.>To perform site inspections regularly & monitor the self-inspections & GMP inspections CAPA compliance.>To comply with the end-to-end activities of Biotech & Sterile plants.>Maintain safe & healthy work environment by following standards, procedures & complying with regulations.>Any other responsibilities assigned by site QA Lead / QA Manager / Quality Director.

Ras Al-Khaimah, United Arab Emirates

>Responsible for productions activities in the respective suits of Recombinant Human Insulin plant & Cephalospororin Sterile Manufacturing plant operations. >Maintain the stocks of production consumable in production area & Supervision of area cleaning & monitoring. >Preparation, Review & Execution of MFM , SOPs related to production. >Maintaining & checking Buffer/Media stock quantity in regular basis to avoid further delay on production & communicating between all departments regularly for any requirements of Buffer/Media. >Maintaining good channels of communication between production management and the post production team and making sure that all production equipment is properly serviced and maintained. >Sterilizing all the required materials & equipments for production activities in aseptic & non-aseptic areas. >Responsible for the CIP & SIP of the production equipments. >Preparation & Filtration of Buffer’s, Media’s & disinfectants required for Production activities. >Adjusting the PH & Conductivity of the Buffer / Media / Product as per the process requirements by adding suitable solvents / materials. >Prior to the production activities verifying the room temperature, RH%, verifying of weighing scale, & document all the activities as per ALCOA principles. >Responsible to follow cGMP norms & the Standard Operating Procedures as defined. >Maintain all logbooks & records, Report any deviation to line manager. >Check & receive the dispensed raw material from stores as per production plan. >Equipments Handled: SCADA, PLC, DCS Operations – SIEMENSPCS7, Preparation Vessels, Centrifuge, Autoclave, Sterilization & Depyrogenation Tunnel, Peristaltic pump, Ultrasonic Vials Washing Machine, Vial Labeling Machine, Filter Integrity Tester

Bengaluru, Karnataka, India

>Responsible for production operation, monitor process parameters and correct the deviations and also responsible for optimizing process conditions to get the desired yield and quality of the product.>Checking the accuracy of product specifications.>To improve the process as well as the equipment efficiencies in terms of productivity, energy consumptions etc to optimize the production cost.>Supervising plant operations and responsibilities for batch startup, performing all related duties as assigned or as situation dictates.>Updating documentation.>Equipments handled: Reactors(SS,GLR,GR), Tray dryers, ANFs, RVDs, HVDs, Cooling towers, Sparkler filter, Nutch filter, Centrifugal pumps, Ejectors, Thermic hot fluids, Heat exchangers, Chillers, Air Compressor, Boiler, FBDs.Good knowledge of cGMP and GMP

Puducherry, India

>Applied lean and fundamental engineering principles to process resulting in production of over one ton of products per day.>Ensuring all shifts are covered by appropriate number of people.>Checking the accuracy of product specifications, performing all related duties as assigned or as the situation dictates.>Walking around the production floor at regular intervals to ensure everything is in order.>Making sure that only quality material is used in the production process.>Reporting on a regular basis to managers and company directors, reporting any non-compliance issues.>Monitoring plant production to ensure consistent material flow and quality.>Controlling the flow of work to meet customer deadlines and recording all relevant information in logs.>Maintaining good channels of communication between production management and the post production team and making sure that all production equipment is properly serviced and maintained.

Kollam, Kerala, India

Learned and Analysed The Production Of Titanium Dioxide.Analysing Raw materials

Bachelor Of Engineering - Be, Chemical Engineering

Higher Secondary, Biology/Biological Sciences, General, 80%

Secondary School, Sslc, 87%