To ensure and carry out regular preventive maintenance and calibrations as per the schedule in GMPPro.To ensure and carry out the periodic performance verification of equipment's, Nitrogen Gas and Compressed Air testing, Temperature Mapping for areas and equipment's and Raw water tanks cleaning as per the schedule.To receive, evaluate the job orders (Ordinary, Preventive Maintenance and Breakdown Maintenance) execute and close.To ensure the validation of HVAC Systems and Equipment's are carried out with proper documentation.To prepare the qualification, temperature mapping and validation protocols and execute the reports for new and reinstalled equipment's.Coordination between engineering and other department personnel for timely completion of trouble shooting activities.Coordination with outside service agencies for validation, calibration, testing and all engineering related activities with coordination of purchase department.To ensure compliance to safety rules and regulations in plant.Designing & Modification of Layouts through AutoCAD.

To execute Daily Project/ modification activity as per priority.Preparation of technical & commercial specifications review of vendor documents & drawings.Preparation of project schedule and execution of projects as per schedule.Coordinating and execution of factory acceptance test of the equipment's at vendor site prior to dispatch.Cost estimation and BOQ preparation as per approved layouts and P&ID. To coordinate with external agencies and contractors for day to day work. Preparation of technical & commercial specifications review of vendor documents & drawingsExecution & Commissioning of Process & Utility equipments like Reactors, Centrifuge, RCVD, ANFD, Filtration equipments, all types of pumps, cooling towers, Chillers, Etc. Within time schedule as per cGMP, Good engineering practices and Safety. New equipments designing and inspection as per User requirements.. Trouble shooting of problems and ensure that no impact on process. Preparation qualification documents (URS, DQ, IQ, OQ, PQ) of Process Equipments, Utility equipment’s and HVAC systems as per cGMP norms and good engineering practices. Ensure that the equipment is installed as per standard specifications.Conduct PSSR (Pre Startup Safety Review) before the start-up of the plant and comply with the findings raised in PSSR if any.Inspect the project equipment's received at the site to ensure that they are matching with the standard parameters as defined in purchase orders during the planning phaseTo ensure all plant surrounding area without spillages & leakages from process lines. Obtaining quotes for required material for the sites, negotiations, and finalization..Any other responsibility assigned by Manager.

Experience in Synthetic R&D Knowledge of name reactions & purification techniques Knowledge of safety practices in lab operations Exposure to ChemDraw and other database tools Good communication & interpersonal skillsPreferred candidate profile M.Sc organic / Medicinal chemistry / PhD Organic Chemistry

Drafting and Review of Investigation Reports in co-ordination with cross functional departments like Production Blocks, Maintenance, Process Engineering, QA, CQA, PR&D, QC and AR&D etc.Preparation of Quality Risk Assessment and its Impact Assessment Reports as or when required.Handling of documents related to Quality Management System (QMS) like Change controls, Deviations, Planned changes, CAPAs etc., as per requirement in co-ordination with cross functional departments like Production Blocks, Maintenance, Process Engineering, QA, CQA, PR&D, QC, AR&D etc.Follow the cGMP compliance by following the SOPs and approved procedures.Responsible for any activities assigned by HOD or Senior Management.

Key ResponsibilitiesNeed to have strong theoretical knowledge (HPLC/LCMS/Prep.HPLC/SFC)Plan and conduct the analysis with required skills.Record the observations meticulously and update to the TL/SME. Share and discuss the observations with supervisor. Independent in maintaining the instrument and setting up the instrument for analysis. Expected to be aware of basics in analytical chemistry (basic analytical techniques Theory and application) as well as handling of laboratory equipment / instruments with basic understanding.Expected to be aware and working in a safety compliant manner

Key Responsibilities : Responsible for co-ordinating with Process R&D and Technology Transfer teams related to new projects to be initiated in Production.Responsible for verification of the new projects initiated in Production Blocks with respect to desired intend in perspective of Quality, Yield, Batch Cycle Time, Safety, etc.Responsible for all the process operations of Production by maintaining the compliance with respect to Safety and Quality.Responsible for preparation & review of production schedule in-line with committed targets.Responsible to deliver the products in accordance with production plan by considering the specific requirements of the customers.Responsible for handling the manpower belongs to Production and deploying the work to them as per their roles and responsibilities.Responsible for ensuring the standard operating procedures are being followed on shop floor without any deviations and enforcing the same consistently.Responsible to prepare, review and revise the Standard Operating Procedures for all operations & systems from time to time with the support of Quality Team.Responsible for ensuring the process operations are carried out as per the batch production records with proper safety measures.Responsible for co-ordinating with service departments & ensuring the activities bearing to service departments are completed as per stipulated time. Responsible for maintaining & monitoring the Good Housekeeping Practices in process areas and sustaining 5S practices.Responsible for all QMS (Quality Management System) documents & its authentication belongs to Productio.Responsible for initiating, reviewing the documents like BPRs, change controls, deviations, investigations and ensuring the timely closure of it as per the procedure.Responsible for carrying out the discussions with cross functional teams in case of any process failures or customer complaints, preparing & reviewing the investigation reports and implementing the suitable CAPA.Responsible to prevent failures from re-occurrence by thoroughly investigating the problem to find an exact root cause to achieve quality at Right First Time (RFT).Responsible to maintain all previous campaign details to review the quality & quantity trends in reference to the process operations and ensure the consistency for the same.Responsible to maintain & manage the inventories & operational expenses of the plant through periodic review.Responsible to train & motivate the team on better work methods, safe operating procedures, cGMP, Business Excellence Initiatives.Responsible to ensure internal & external audit compliance with respect to safety & quality.Responsible to motivate the team for improvements projects like Cost Reduction, Capacity Enhancement and Operation & Quality improvement.Responsible for solvent related activities like stock verification, spent disposal, solvent treatment, emission control, etc.Responsible to participate Behaviour Based Safety (BBS) programs and enforce & train the team to report all safety related events/ incidents immediately without delay. Responsible to prepare & review the qualification and validation documents like VMP, URS, DQ, IQ, OQ and PQ in-line with regulatory guidelines.Responsible to prepare a& review HSE documents like process & facility Hazop, Also ensuring the work permit system is strictly followed in the Production Block

1. Responsible for performing analysis by LC-MS/GC-MS/Ion chromatography analysis to identify and quantify impurities in different types of pharmaceuticals products.2. Impurity profiling in the different pharmaceuticals products or NCEs by LC-MS/MS or GC-MS.3. Have an expertise and experience in method development and optimization LC-MS methods for identification, detection, separation and quantification of target compound like GTIs and Nitrasoamine impurities.4. Structure Elucidation Reports preparation by using Mass and NMR analysis5. Handling of AB Sciex Q TRAP 4500 and Waters HRMS MSC chemistry with 10-12 years of experience

Qualification: M.Sc. / Ph.D. in Organic Chemistry Experience:M.Sc. 2-8 yearsPh.D./Post-Doc 0-3 years of experience Key responsibilities & skills:Excellent knowledge of synthetic organic chemistry for the synthesis of API & advanced Intermediates (medicinal chemistry experience as well).Experience in the Design of Chemistry routes (Route Scouting) & early phase processes for the scale-up of novel raw materials, intermediates, and APIs.Knowledge of safety practices in laboratory operationsPreferable from CDMO / CRAMS divisionGood communication and interpersonal skills

Excellent knowledge of synthetic organic chemistry for the synthesis of API & advanced Intermediates (medicinal chemistry experience as well).Experience in the Design of Chemistry routes (Route Scouting) & early phase processes for the scale-up of novel raw materials, intermediates, and APIs.Knowledge of safety practices in laboratory operationsPreferable from CDMO / CRAMS divisionGood communication and interpersonal skills

Key Responsibilities To timely kick off the awarded projectTo timely prepare and update, comprehensive Gantt chart for the project delivery scheduleRegularly coordinate and have a daily & weekly review meetings with engineering function leads like electrical, mechanical civil, instrumentation, QMS etc Coordinate with have a weekly review meeting with CFT like end users, EHS, QA, through weekly meetings as well as issue based meetingsTo prepare and update the comprehensive action tracker for the each projectTo send the prescheduled updates to the engineering leads as well the CFTTo schedule the telcons / Teams Call with leads in a structured way with in engineering fuction as well with CFTTo highlight and escalate the road blocks or anticipated road blocks to the Engineering HOD / Senior teamTo ensure complete and timely documentation on project closurePerformance IndicatorsProjects completions as per commitmentOverall management of projects, project creeps and communications2. Job specifications / pre-requisites:(Qualification, experience, any other specifications)Chemical / Mechanical Engineer, with minimum 6 years’ experience in handing of project management in the filed of bulk drugs, pharmaceuitcals, API etc. PMP certification and / or MBA desired, but not must.Additionally, minimum 4 years’ experience as Program Manager with a reputed organization. QualificationMasters/ Bachelors (preferred PMP certified , not Mandatory) Experience10+ Years Key Competencies (Technical, Functional & Behavioral) - Excellent verbal and written communication, persuasiveness, inter-personal skills, adaptability, foresight, understanding of business processes.

Key Responsibilities :Raise awareness & sensitize engineers across all functions to comply GEP, Job order status, Kaizen, 5S, single point lesson, Gemba walks, Break-down investigation. Make a list of Non negotiables in engineering practices and enforce it through various initiatives. Data for analysis using well-defined engineering techniques, principles and procedures.Carry out root cause analysis & ensure CAPA implementation to prevent failure repetition. Design and develop new and unique engineering methods and procedures, special equipment, innovative test procedures and special analysis of failure techniques. Train other engineers and implement advanced predictive maintenance and condition based maintenance techniques to improve asset health. Train other engineers and implement latest continuous improvement tools to enhance problem solving approach, innovation methods, motivate fellow engineers & implement best practices. Do a thorough analysis of PM checklist, SOP, general & specific PM tools & consumables, annual man-hour utilization for PM optimization. Device a method to improve daily work management within engineering function. Ensure all the MEP stake-holders are well communicated and their issues are addressed on time. Develop methods & programs to improve 5S, Housekeeping & Visual management Initiatives to uplift Utility in terms of asset reliability and visual management & lean tools. Impart training to engineers and fitters on Good engineering practices and skill gap analysis. Weekly and Monthly review on MEP activities for each pillar with all pillars and senior management. CMMS implementation to enhance maintenance capabilities and improved reporting. Implement MEP initiatives across other site as well.Implement any other activity as guided by the reporting manager

Key Responsibilities To timely kick off the awarded projectTo timely prepare and update, comprehensive Gantt chart for the project delivery scheduleRegularly coordinate and have a daily & weekly review meetings with engineering function leads like electrical, mechanical civil, instrumentation, QMS etc Coordinate with have a weekly review meeting with CFT like end users, EHS, QA, through weekly meetings as well as issue based meetingsTo prepare and update the comprehensive action tracker for the each projectTo send the prescheduled updates to the engineering leads as well the CFTTo schedule the telcons / Teams Call with leads in a structured way with in engineering fuction as well with CFTTo highlight and escalate the road blocks or anticipated road blocks to the Engineering HOD / Senior teamTo ensure complete and timely documentation on project closurePerformance IndicatorsProjects completions as per commitmentOverall management of projects, project creeps and communications2. Job specifications / pre-requisites:(Qualification, experience, any other specifications)Chemical / Mechanical Engineer, with minimum 6 years’ experience in handing of project management in the filed of bulk drugs, pharmaceuitcals, API etc. PMP certification and / or MBA desired, but not must.Additionally, minimum 4 years’ experience as Program Manager with a reputed organization. QualificationMasters/ Bachelors (preferred PMP certified , not Mandatory) Experience10+ Years Key Competencies (Technical, Functional & Behavioral) - Excellent verbal and written communication, persuasiveness, inter-personal skills, adaptability, foresight, understanding of business processes.