115 Jobs in Jadcherla

Company Description LEESA LIFESCIENCES PRIVATE LIMITED is a mining and metals company located in Jadcherla, Mahbubnagar, Telangana, India. Our company operates out of several sites and specializes in innovative solutions in the mining and metals sector. We are committed to sustainable practices and excellence in the field, aiming to set new standards in the industry. Role Description This is a full-time on-site role for a Civil Engineer located in Jadcherla. The Civil Engineer will be responsible for performing civil engineering design, planning, and stormwater management. Day-to-day tasks include drafting, reviewing project drawings, managing construction projects, and ensuring compliance with safety and environmental regulations. The Civil Engineer will also collaborate with other engineers and professionals to deliver high-quality projects within specified deadlines. Qualifications Civil Engineering Design and General Civil Engineering skills Experience in Civil Engineering and working as a Civil Engineer Planning and Stormwater Management skills Strong analytical and problem-solving abilities Excellent project management skills Bachelor’s degree in Civil Engineering or related field Experience in the mining and metals industry is a plus

Boiler Operation:Operate and control high-pressure boilers to generate steam or hot water Monitor boiler gauges, meters, and controls to ensure proper functioning Safety Compliance:Adhere to safety protocols and guidelines for boiler operation Conduct regular safety checks and inspections to prevent accidents Equipment Monitoring:Monitor and adjust boiler parameters to maintain optimal efficiency and performance Respond to alarms or abnormalities in the operation of the boiler Maintenance:Perform routine maintenance tasks, such as cleaning, lubricating, and replacing worn components Schedule and oversee periodic inspections and repairs Water Treatment:Manage water treatment processes to ensure the proper chemical balance in the boiler system Conduct water tests and adjust chemical dosages as needed Record Keeping:Maintain accurate logs and records of boiler operations, maintenance activities, and inspections Document fuel consumption, water levels, and steam production Emergency Response:Respond to emergency situations, such as equipment malfunctions or power outages Take appropriate actions to mitigate risks and ensure the safety of personnel Collaboration:Collaborate with other operators, maintenance personnel, and engineering staff Communicate effectively with team members and supervisors

HIRING FOR OSD - PRODUCTION & QC PRODUCTION(OSD) Experience: (01-07Years) Compression, Granulation, Coating, Capsule filling, Inspection QC Experience: (02-09Years) HPLC, GC, RM,PM, Stability, IP/FP, Method Development, Method Transfer QUALIFICATION : ITI/DIPLOMA/BSC/MSC/B PHARM/M PHARM With relevant Experience ITI/DIPLOMA/BSC/MSC/B PHARM Freshers can Apply DESIGNATIONS: Operator/Sr Operator/Jr Officer/Officer/Jr Executive/Executive INTERVIEW VENUE: SK Consultancy Services, H.No-1-77, 3rd Floor, Bachupally X Road, Opposite Sri Swastik Multi Specialty Hospital, Towards Nizampet Road DATE &TIME: 26th July 2025 ( Saturday); From 09.00 A.M. to 03.00 P.M NEED TO CARRY: Resume 3 Month Pay slips Increment letter Previous company relieving letters Education Documents and ID Proofs Help Us Spread the Word (Refer): Circulate it in your Social Networking sites and groups for better reach and Refer your friends and colleagues, it could be a great opportunity for someone in need! WORK LOCATION: Hetero Labs Limited, UNIT V Polleypally, Jadcherla, Mahabubnagar CONTACT INFO: E-mail: Ashok.ch@hetero.com & Contact:8555912639 for further info.

We are seeking a visionary Plant Head to revolutionize operational excellence. As a pivotal leader, you will drive the company's mission to deliver high-quality pharmaceutical solutions worldwide. Collaborating with cross-functional teams, including tech transfer, sales, and quality control, you will ensure seamless operations and timely dispatches. This role offers a unique opportunity for professional growth, with exposure to global markets and cutting-edge pharmaceutical practices. Must-Have Master's degree (Preferred), 25+ years of experience, Expertise in Production Planning, Quality Control, and Engineering Management, Experience in Regulatory Compliance Exposure to Contract Manufacturing and Development Environments Job Responsibilities Operational Management Monitor and evaluate quality, productivity, and engineering processes to ensure optimal performance and adherence to industry standards. Lead and oversee continuous improvement projects aimed at enhancing operational efficiency and reducing waste. Ensure strict compliance with international standards and regulatory requirements, including statutory and pollution control board regulations. Manage production planning and inventory control to align with demand forecasts and minimize stockouts or excess inventory. Team Leadership and Development Mentor and develop team members to enhance their skills and contribute to their professional growth. Lead troubleshooting efforts across all departments to resolve technical issues promptly and effectively. Foster a collaborative and inclusive work environment that encourages innovation and open communication. Guide and support the technology transfer team to ensure seamless integration of new processes and products. Customer and Sales Coordination Support the Quality Control Team and Material Planning based on production planning to meet quality and delivery standards. Coordinate with sales teams to ensure timely dispatches and alignment with customer expectations. Manage customer communications effectively to ensure satisfaction and address any concerns promptly. Strategic Planning and Innovation Develop and present Management Information System (MIS) reports to senior management for informed decision-making and strategic insights. Implement energy conservation and efficiency measures to reduce operational costs and environmental impact. Drive strategic planning initiatives focused on achieving operational excellence and long-term business goals. Regulatory Compliance and Quality Assurance Enhance statutory compliance measures to align with evolving regulations and industry best practices. Coordinate with regulatory bodies to ensure all operations meet statutory requirements. Oversee quality assurance processes to maintain high standards in product formulation and development. Ensure compliance with global pharmaceutical standards and regulatory requirements. Innovation and Process Optimization Collaborate with cross-functional teams to implement new technologies and methodologies. Encourage innovation in production techniques to maintain competitive advantage. Lead initiatives in process optimization to enhance productivity and efficiency.

Role & responsibilities : Only for male candidates Shri Kartikeya Pharma [Jadcherla / India] located in JADCHERLA TELANGANA, India had its last known inspection on 04 Jan 2024. There are 1 known inspections on record Preferred candidate profile Freshers,1-2 yrs

Role & responsibilities Plant overheads accounting. Imprest & advances analysis & recovery. Statutory compliances as per calendar GST & TDS and Returns GST Working Departmental MIS . Handling receivables and payables Maintaining minimum cash balance & making it available to meet day-to-day plant requirements. Release of salaries at the latest by 7th of next month Preferred candidate profile : Strong Knowledge in Finance & Accounting , statutory compliance , GST & TDS returns.

Job Title Executive/Sr Executive Environment, Health & Safety (EHS) and ETP Role Overview An executive-level role responsible for steering the companys EHS strategyensuring workplace safety, environmental compliance, and the effective operation of the Effluent Treatment Plant (ETP). This position oversees all EHS and ETP activities, integrates them into the broader pharmaceutical manufacturing process. Key Responsibilities 1. EHS Leadership & Strategy Develop EHS policies aligned with ISO 14001/45001 standards and corporate sustainability goals Lead EHS team in risk assessments, audits, incident investigations, and corrective actions Drive safety culture via training, toolbox talks, Gemba walks, and committee governance 2. Regulatory Compliance & Reporting Ensure compliance witlocal/regional regulations, including environmental permits (CFO, CFE, Form IV/V) Liaise with government bodies during inspections and audits; submit statutory filings (wastewater, emissions) 3. ETP Operations & Oversight Oversee daily operations of the Effluent Treatment Plant (ETP), including monitoring, troubleshooting, preventive maintenance, and equipment calibration Analyze effluent data and adjust processes to meet discharge standards and pollution prevention targets Maintain ETP documentation: log sheets, operational records, maintenance tickets, and regulatory compliance files 4. Environmental Management & Sustainability Manage environmental footprint: water use, energy conservation, hazardous waste, solid waste, air emissions. Lead Zero Liquid Discharge (ZLD) or wastewater recycling initiatives where applicable 5. Emergency Preparedness Develop and lead emergency response drills (fire, chemical spill, ETP upsets) Ensure readiness of emergency equipment (pumps, alarms, SCBA) and training compliance 6. Team Management & Stakeholder Engagement Mentor and develop junior EHS/ETP staff; promote cross-functional collaboration with engineering, operations, QA, and contractors. Partner with Corporate EHS to align site EHS/ETP systems with global corporate standards 7. Continuous Improvement Implement data-driven improvements in safety and effluent processes; monitor KPIs (incident rates, effluent quality, uptime) Integrate EHS and ETP considerations into new facility designs and capital projects Qualifications & Experience Bachelors degree /Diploma in Environmental Engineering, Chemical Engineering, Industrial Safety, Environmental Science or related field. 5-9years of progressive experience in pharmaceutical EHS, including direct ETP management. In-depth knowledge of ETP technologies, wastewater regulations, and pharma effluent standards Certifications preferred: NEBOSH, CSP, CIH, CHMM, ISO lead auditor. Familiarity with ISO 14001,ISO 45001, Process Safety Management, and pharmaceutical regulatory frameworks. Why This Role Makes an Impact By combining executive-level EHS leadership with direct operational oversight of the ETP, this role ensures pharmaceutical manufacturing remains safe, sustainable, and compliant, while minimizing environmental impact. Perks and Benefits: Competitive Salary Package Provident Fund, Gratuity, and Medical Insurance How to Apply: Interested candidates may apply directly through Naukri or send their updated CV to sharadha.b@hetero.com with the subject: Application for Executive/Senior Executive EHS | Jadcherla

Job Title HotMelt Extruder Operator OSD Pharmaceutical Production Company Overview We are a leading pharmaceutical manufacturer specializing in continuous oral solid dosage (OSD) products. Our facility utilizes hot-melt extrusion Key Components of the Extruder in Granulation Feeder : Delivers the powders or wet granulation material to the extruder barrel. Screw : The screw inside the barrel performs the compaction, mixing, and shearing functions. The screw is typically a caterpillar screw or conveyor screw . Barrel : The barrel houses the screw and is where the material undergoes compaction and mixing. Die Plate : The plate with holes that shapes the extruded material into strands or granules. Heating/Cooling System : Some extruders have heating or cooling elements in the barrel to maintain the desired temperature during the granulation process. Qualifications & Skills Education & Experience • Diploma/BSC//ITI/Inter • 38 years of experience in hot-melt extrusion, ideally in pharmaceutical OSD . Why Join Us? Be at the forefront of continuous pharmaceutical manufacturing using hot-melt extrusion. Advance your technical expertise in a high-tech, GMP-regulated environment. Enjoy competitive salary, shift flexibility, healthcare benefits, and performance incentives. Job Details Location: Jadcherla (Hyderabad) Compensation: Competitive package with benefits How to Apply Send your updated resume through : Sharadha.b@hetero.com Contact Number : 8121037956

Responsible for following activities in purification area of BM/BU based on campaign basis 1. Following GMP, safety practices in production facilities and work place. 2. Responsible for production activities: Execution of area, line clearance before execution of activities. Execution of product changeover activities. Responsible for column cleaning, packing, unpacking, evaluation and maintenance. Responsible for drug substance (FDS) transfer/dispensing. Execution of production activities. Monitoring and review of batch parameters/performance. Ensuring material are arranged properly before activities. Verification of samples for analysis. Responsible for shift Monitoring. Handling of online reject material. Review of soft copy for batch monitoring and performance. Execution of process validation. Execution of cleaning validation. Execution of verification protocols/equipment specific protocols. Ensuring buffer preparation in respective shift. 3. Handling of documents: Preparation of new / revision of SOPs, protocols and reports. Preparation of MFRs and BMR's. Primary review of executed BMR's submission to QA. Ensuring online BMR's updation and review of log books. 4. Responsible for monitoring and operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter TFF System Peristaltic pumps Weighing Balance Mixing Systems Biosafety cabinet Filter integrity tester pH meter Walk in cold Freezer room Heat Exchanger Mixing vessels Ensuring proper data backup of equipments. Provide clearance for calibration, PMP and validation of equipments. Participate in execution of equipment validations. 5. Responsible for Quality Management Systems Initiation / Review of breakdown request. Initiation of CRN's and Preparation of Risk Assessments. Initiation of incidents, investigation, CAPA. 6. Team member: Facility readiness for audits. 7. Training: Training team members on SOPs / GMP aspects. Attending training on related SOP's / GMP aspects. 8. Monitoring of PM/Qualification of purification area equipments. (Calibration / PMP/Qualification).ease enter job description

1. Responsible for operation and cleaning of Vial washing machine, Depyrogenating tunnel, Vial / PFS filling stoppering machine, vial sealing collection machine and Lyophilizer. 2. Responsible for involvement in aseptic media fills formulation and filling activities in aseptic areas. 3. Responsible for operation and cleaning of HPHV Steam sterilizer. 4. Responsible for cleaning, preparation of components as per load pattern. 5. Preparation and filtration of disinfectants, IPA etc., 6. Responsible for area and equipments cleaning in FP facility. 7. Handling of APA equipments and to be involved in personnel gowning qualification. 8. Online Execution of Batch documents and related logbooks. 9. Handling of various types of filters and filter integrities. 10. Execution of preventive maintenance plan for equipments in coordination with engineering. 11. Maintaining of day to day activities in manufacturing areas 12. Performing DQ, IQ, OQ, and PQ for the equipments in aseptic processing area and other associated areas. 13. Reporting all the activities like incidents and problems to reporting officer. 14. Participate in all training related programs for individuals in respective area. 15. Responsible for handling, movement of DS/FDS and DP. 16. Achieving planned FP targets with cGMP

1. Responsible for operation and cleaning of HPHV steam sterilizer 2. Responsible for operation and cleaning of vial washing machine and depyrogenation tunnel. 3. Responsible for cleaning, preparation of filling machine parts and load patterns. 4. Responsible for washing, drying and preparation of garments for manufacturing areas. 5. Preparation and filtration of disinfectants, IPA etc. 6. Cleaning of equipments and rooms in processing areas. 7. Online Execution of Batch documents and related logbooks. 8. Handling of various type of filters and filter integrities. 9. Participate in qualification of equipments (DQ, IQ, OQ and PQ) in manufacturing areas. 10. Execution of production related activities and achieving planned FP targets with cGMP. 11. Following of cleaning procedures and entering data in the relevant logbooks. 12. Maintaining of day-to-day activities in manufacturing areas. 13. Reporting all the activities and problems to reporting officer. 14. Follow the regular training programmers for individuals in respective area 15. responsible for operation of vial and PFS filling machine. 16. Responsible for operation of vial sealing machine 17. Responsible for operation of Lyophilizer.

1. Responsible for review of specifications, STPs, GTPs and analytical test data sheets. 2. Review of analytical reports of raw material, packing materials, water samples, product samples, OOT, water trends and ensuring compliance. 3. Responsible to attend the training programs. 4. Responsible for monitoring of quality control Lab (Daily calibration, PMP, Instruments back up data, Excel work sheets lock, user log books). 6. Responsible for handling technology transfer documents. 7. Responsible for review of stability protocols, stability analytical data and summary reports. 8. Responsible for handling of change controls, OOS, OOT, Incidents and investigations. 9. Responsible for compliance of GLP in Lab. 10. Responsible for review and approval of LIMS related activities. 11. Approval and issuance of configured COA in LIMS. 12. Responsible for audit trail verification for QC lab instruments.

1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for compilation and review of validation raw data and test certificates. 5. Responsible for preparation and review of Computerized system validation (CSV) documents and execution of CSV for equipments. 6. Responsible for preparation of User Requirement Specification, Design Qualification, FAT protocols, SAT protocols, Installation qualification, Operational qualification and Performance qualification, Revalidation protocols and reports. 7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments. 8. Responsible for In-process assurance of Engineering department activities like utilities monitoring, verification of log books, PMP records, review of Schedules and calibration records. 9. Responsible for co-ordination with user department and validation service providers for execution of qualification activities. 10. Responsible for handling and review of risk assessments, deviation, change control and incidents related to qualification activities and user department activities. 11. Responsible for preparation of Utilities Annual summary reports.

1. Preparation, review and revision of SOPs, GTPs and Work sheets. 2. Execution of analytical method validation protocols for product samples. 3. Testing and review of product / Miscellaneous samples for AET. 4. Operation and maintenance of laboratory Instruments. 5. Monitoring of temperature, DP and RH of the Microbiology laboratory. 6. Involve in the execution of Media fill validations. 7. Cleaning, verification of laboratory cleaning and glassware cleaning in the Microbiology laboratory. 8. Receipt, storage, preparation, sterilization and maintenance of sterile media and reagents. 9. Performing the isolation, identification and confirmation tests for test organisms and Isolates. 10. Responsible for Growth promotion, inhibition test of Microbiological culture media. 11. Responsible for Biological indicator qualification, usage and testing. 12. Culture maintenance in Microbiology department. 13. Preparation and usage of disinfectants. 14. Review of outside COAs. 15. Review, checking and verification of all types Microbiology laboratory documents. 16. Responsible for implementation activities related to resource manager and sample manager of Laboratory information management System #40;LIMS#41;. 17. Verification of cleaning in the Microbiology laboratory. 18. Responsible for compliance to cGLP.

Planning and executing assay-runs for cell based assays and ELISA as part of Method Development and Method Qualification studies Analysis of the data using parallel line analysis and equivalence testing Writing protocols and reports for Method development and Method qualification studies Maintenance of the cell lines, preparation of cell banks Review of raw data and data recording sheets and to ensure good documentation practices. Planning of day-to-day activities independently. Trouble shooting of the issues (if any) aroused during execution of assay-run. Involving in documents preparation for SOP, STP, MOA.

1.Responsible for giving line clearance between startup of various finished product formulation and filling operations. 2.Responsible for performing in process checks during finished product operations as per respective established procedures. 3.Responsible for Monitoring and Coordination of process validation, Hold time studies, media fill and cleaning validation activities. 4. Responsible for preparation of IPQA SOPs and review of finished product SOPs. 5. Responsible for preparation of Annual Product Review Reports. 6. Responsible for continued process verification reports. 7.Responsible for compliance to GMP in finished product area. 8.Responsible for review of all finished product log books. 9.Responsible for review of master MFR and executed BFRs. 10.Responsible to attend training programs and SOP trainings. 11.Responsible for preparation of media fill BFR, protocol and report. 12.Responsible for monitoring of stability samples. 13.Responsible for preparation and review of visual inspection qualification protocol and report. 14.Day to Day Manufacturing observations Report to Manager QA.

1. Preparation and Maintenance of SOPs, STPs, Specifications, GTPs and Worksheets related to Product testing. 2. Preparation, revision, review and execution of Analytical method Validation protocols and reports related to product testing. 3. Responsibilities for preparation of masters (Product, Specifications, Tests, worksheets, Test plans and TTD etc.) in LIMS. 4. Responsibilities for effective documents (STPs, Specifications and GTPs etc.) uploaded in LDMS. 5. Responsible for material management like weekly, monthly indent Ensure monthly indents are placed and materials received in timely manner, reservation placed through SAP. Ensure compliance `w.r.t expiry, usage and discard of materials. 6. Operation and calibration of QC Instruments related to product testing. 7. Testing and release of product samples by techniques such as: General tests (Physical appearance, pH, Color, Extractable volume, Osmolality, Conductivity, etc.) Gel Electrophoresis (IEF, SDS-PAGE, etc.) Colorimetric assays (Sialic acid, Quantification of Polysorbate 80 and Polysorbate-20, etc.) Quantification assays (Protein concentration by absorbance (Spectral scan)/Protein content by UV (OD @ 280 nm, Trehalose dihydrate, Mannitol, Sucrose, etc.) ELISAs (Host Cell derived Proteins, Protein A Leachate, etc.) Q-PCR (Host Cell DNA, Mycoplasma testing etc.) HPLC techniques (Product concentration by RP-HPLC, Size Exclusion chromatography, Peptide mapping, etc.) UPLC techniques (Cation exchange chromatography, Protein A Chromatography, N-Linked Glycans by hydrophilic liquid interaction chromatography, etc.) 8. Preparation of reagent solutions, buffers and maintenance of the records. 9. Temperature and humidity monitoring of labs and instruments. 10. Sample receiving, A.R. No allotment, Testing, Documentation and reporting of analytical results in LIMS for In process, batch release, stability and Miscellaneous samples related to product testing. 11. Withdrawal and aliquoting of batch release and stability samples for analysis. 12. Responsible for preparation of shift schedules and test planning activities. 13. Responsible for cGLP compliance. 14. Responsible for handling of OOT (Out Of Trend), OOS (Out Of Specification), Incidents, LIRs and Change controls related to product testing. 15. Responsible for change management: Ensure CRNs initiation and closure within target date. 16. Preparation, revision and review of miscellaneous protocols and reports related to product testing. 17. Review of analytical data and work sheets related to product testing. 18. Maintenance of stability samples and reserve samples related to product testing. 19. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. 20. Responsible for usage, monitoring and verification of all kind of laboratory books. 21. Preparation, execution and review of reference standard qualification. 22. Maintenance of all QC documents related to product testing. 23. Assist in execution of Analytical method validations.

The candidate would be developing various analytical method (such as CD, Fluorescence spectrscopy ,CE UH/HPLC etc..)for CQA to support biosimilarity and analytical studies. Qualify method for biosimilarity and analytical studies. Responsible for performing biosimilarity, characterization and analytical studies for various molecules across lifecycle . Evaluation, interpretation and graphical representation of the measurement data as well as presentation of the results obtained from multiple experiments. Author technical documents such as MoA,MQR,SOP,study protocol and report.

1) Development of mass spectrometry based methods for analysis of various molecules for pivotal studies such as biosimilarity, comparability etc.. 2)operation and maintenance of mass spectrometry instrument and performing troubleshooting activities 3)developing and carrying out multiple assays aimed at characterization of protein based therapeutics across various stage of the project 4) participate in design, development and implementation of methods for CQA/impurity characterization of molecules. Interpret results,and draw conclusions from multiple stage experiments 5) Author technical documents such as SOP,MoA,study protocol and reports for method and product development

1. Responsible for operation and cleaning of HPHV steam sterilizer 2. Responsible for operation and cleaning of vial washing machine and depyrogenation tunnel. 3. Responsible for cleaning, preparation of machine parts and load patterns. 4. Responsible for Washing and preparation of garments for manufacturing areas. 5. Preparation and filtration of disinfectants, IPA etc. 6. Cleaning of equipments and rooms in processing areas. 7. Online Execution of Batch documents and related logbooks. 8. Handling of various type of filters and filter integrities. 9. Participate in qualification of equipments (DQ, IQ, OQ and PQ) in manufacturing areas. 10. Execution of production related activities and achieving planned FP targets with cGMP. 11. Following of cleaning procedures and entering data in the relevant logbooks. 12. Maintaining of day-to-day activities in manufacturing areas. 13. Reporting all the activities and problems to reporting officer. 14. Follow the regular training programmers for individuals in respective area

1. Aseptic handling. 2. Media and feeds preparation for shake flasks experiment and bioreactors batches. 3. Shake flasks handling for clone, media and feed selection. 4. Bioreactors preparation (1L,5L,20L). 5. Batch execution in small scale bioreactors and large-scale bioreactors. 6. In process sample analysis like cell count, viability, metabolites (glucose, lactate, ammonia, glutamine etc. 7. SOP preparation related to instruments and process. 8. Shift duties for batch monitoring. 9. Able to work in a team.

1. To perform Area cleaning. 2. To perform Equipment operation and cleaning. 3. To perform the visual inspection and packing activities. 4. To perform the documentation as per Batch record and SOP. 5. Responsible to maintain documents as per cGMP norms. 6. Ensure the training completion before doing activity. 7. Maintain personal hygiene. 8. Reporting all the activities, incidents and problems to Reporting officer.

1. Responsible for operation and cleaning of PFS/Vial filling stoppering and Sealing machine. 2. Responsible for operation and cleaning of Lyophilizer machine. 3. Responsible for involvement in aseptic media fills formulation and filling activities in aseptic areas. 4. Responsible for operation and cleaning of HPHV steam sterilizer. 5. Responsible for cleaning, preparation of machine parts and loads as per load pattern. 6. Preparation and filtration of disinfectants, IPA etc., 7. Responsible for area and equipments cleaning in FP facility. 8. Handling of APA equipments and to be involved in personnel gowning qualification. 9. Online Execution of Batch documents and related logbooks. 10. Handling of various types of filters and filter integrities. 11. Execution of preventive maintenance plan for equipments in coordination with engineering. 12. Maintaining of day to day activities in manufacturing areas. 13. Performing DQ, IQ, OQ, and PQ for the equipments in aseptic processing area and other associated areas.

1. Receipt, storage and usage of medias, Microbial cultures, materials and documentation 2. Perform viable / non-viable monitoring activities, media plates observations and documentation in testing facilities. 3. Environmental monitoring, sampling, receipt, testing and documentation of all Microbiology samples. 4. Perform cleaning, fumigation and other activities in Microbiology laboratory. 5. Monitoring of temperature, DP and RH of the Microbiology laboratory. 6. Preparation of dilute disinfectants, reagents solutions / indicator solutions. 7. Responsible for compliance to cGLP. 8. Operation and usage of instruments. 9. Execution of method validations / method verification samples. 10. Receipt / testing of validation samples from manufacturing / other areas 11. Training and qualification of analysts in Microbiology department. 12. Responsible for handling of Bio-waste in Microbiology department. 13. Review, checking and verification Microbiology laboratory documents. 14. Responsible for implementation activities related to resource manager and sample manager of Laboratory information management System #40;LIMS#41;

1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for operation and handling of Dataloggers, HVAC related equipments. 5. Responsible for compilation and review of validation raw data and test certificates. 6. Responsible for preparation of Installation qualification (IQ), Operational qualification (OQ) and Performance qualification (PQ), revalidation protocols and reports. 7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments. 8. Responsible for In-process assurance of Engineering department activities like utilities monitoring, verification of log books, PMP records, review of Schedules and calibration records. 9. Responsible for co-ordination with user department and validation service providers for execution of qualification activities. 10. Responsible for handling of risk assessments, deviation, change control and incidents related to qualification/validation. 11. Responsible for preparation of Utilities Annual summary reports.