Role & responsibilities Will be responsible for handling HVAC, water treatment plant, compressed air, handling of boiler/chiller/air compressor & ETP and pharmaceutical machinery, repairs and maintenance. Responsible for BMS systems, handling PLCs and also Handling of DQ, IQ, OQ and PQ. Keeping equipment operational by coordinating maintenance and repair services, following manufacturer's instructions and established procedures. Will be responsible for confirming system and product capabilities by designing feasibility and testing methods, testing finished product and system capabilities; confirming fabrication, assembly, and installation processes. Responsible for keeping equipment operational by coordinating maintenance and repair services; Maintain product and company reputation by complying with government regulations Develop processes by designing and modifying equipment as per the requirement and making sure the project is completed by training and guiding technicians. Prepare reports by collecting, analyzing, and summarizing information and trends. Provide engineering information by answering questions and requests. Maintain system and process data base by writing computer programs and entering data. Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies. Responsible for any other assignment allocated by the Department Head. Looking after such other task and work assign by your Manager & Management as and when required.
Job Responsibility Will be responsible for Production Planning, Allocation of manpower, Daily work distribution, Dispensing of RM & PM, Maintaining Daily cleaning, Calibration etc. records, Documentation etc. ERP& BMR Preparation and Review Maintain the SOPs, Log books & other documents. Oversee and manage the entire manufacturing process. Handle Granulation, Coating and all other production related activities. Active calculation, dispensing of raw materials and batch reconciliation at various stages. In process checking at various intermediate stages of granulation, compression and coating. Should handle process of validation batches. Ensure online documentation of production activity on timely basis. Review of batch manufacturing record and other related documents for its completion of intermediate and final stage. Prepare IQ, OQ & PQ of the process & utility equipment. Must be familiar with the cGMP guidelines Must have excellent communication skills Must have experience in facing regulatory audits.
Role & responsibilities To develop Pellets Mups, Capsules,. Literacture review, patent search. Preformulation Study. Product Development, Compatiblity Study. Pre-formulation trials, Process Development. Shop Floor TroubleShooting. Prepare document, PDR, MFR, Process BMR, Master Formla Card. Technology Transfer.
Role & responsibilities Should have knowledge of SLD drawing Should be able to read the Electrical and Mechanical Drawing. Should be able to understand of P&ID and isometric Drawing. Basic knowledge of AutoCAD Hands on experience of Budget preparation of project work. Hands on experience on Project planning, handling and management. Should have able to manage material stock and record for consumption sheet preparation. Understand Companys Health & Safety Policy and follow all company HSE procedures. Should able to deliver the assigned task on time. Finalization of technical specification of machine Hands on experience on documentation like OQ,IQ,URS etc. Hands on experience of execution and commissioning of pharma machineries and utility Equipments Should have knowledge of HVAC system and clean room applications Should have knowledge of CGMP and revised schedule M Hand on experience of solid oral facility (Nutraceutical experience also be considered)Hands on Experience of WTP/utilities (Boiler, Chiller, WTP, Compressor, ETP, STP) piping, installation and commissioning. Hands on experience of vendor co ordination Should be able to present Project status/ reports and Daily work status/report. Manpower handling Hands on experience on Facility qualification, HVAC and Compressed Air Validation Provide technical input as required to ensure projects progress in line with their scope requirements. Support the development and completion of documentation in relation to purchasing, planning, implementation, commissioning and validation activities in relation to the above. Be responsible for Supervision of 3rd party contractors and internal service providers Be responsible for tracking and reporting project delivery, ensuring projects are delivered on time and within budget. Ensure training has been Given before undertaking specific duties and that all training is recorded in training records. Preferred candidate profile 5-7 years of hands-on experience in project engineering or project management roles within OSD pharmaceutical manufacturing . In-depth knowledge of OSD manufacturing processes , equipment, utilities, and facility layouts. Familiarity with HVAC , cleanroom classification, and GMP /cGMP requirements. Hands-on experience with equipment installation, commissioning, and qualification (IQ/OQ/PQ).
Role & responsibilities To maintain the QA documents in compliance state and ensure they are all time ready for internal and external audits. Preparation and review of SOPs. To act as training coordinator and oversee implementation & compliance of training matrix. To maintain the vendor approval document. Daily issuance and retrieval of records of other departments. To maintain records of change control, deviations, CAPA, incidents logs, OOS, OOT. To prepare and maintain calibration and validation schedules of equipments as per VMP. Upkeep and follow-up for new product licenses. To prepare APR, trends. Prepare and review of BMR and analytical reports. Upkeep of retain samples and controls samples and their records. To maintain GMP in the plant and identify problem areas and report to Head-Quality. Line clearance in dispensing and production area. To perform in-process sampling, testing and document the observations. To handle IPQA activity in warehouse and production area.
Role & responsibilities Oversee and manage the entire manufacturing process. Handle Granulation, Compression , Coating and all other production related activities. Active calculation, dispensing of Raw Materials and batch reconciliation at various stages. In process checking at various intermediate stages of Granulation, Compression and Coating. Prepare IQ, OQ, & PQ of the process & utility equipment. Should handle process of validation batches Ensure online documentation of production activity on timely basis. Review of batch manufacturing record and other related documents for its completion of intermediate and final stage. Maintain the SOPs, Log books and other documents. BMR / BPR preparation in ERP and review.
Role & responsibilities Will be responsible for handling HVAC , water treatment plant, compressed air, handling of bolier /chiller/air compressor & ETP and pharmaceutical machinery, repairs and maintenance. Handling BMS systems, handling PLCs and DQ, IQ and PQ. Keeping equipment operational by coordinating maintenance and repair services, following manufacturer's instructions and established procedures, requesting special services. Will be involved in handling all pharmaceutical machinery. Responsible for confirming system and product capabilities by designing feasibility and testing methods, testing finished product and system capabilities; confirming fabrication ,assembly, and installation processes. Responsible for keeping equipment operational by coordinating maintenance and repair services; Maintain product and company reputation by complying with government regulations Develop processes by designing and modifying equipment as per the requirement and making sure the project is completed by training and guding technicians. Prepare reports by collecting, analizing and summarizing information and trends. Provide engineering information by answering questions and request. Maintain system and process data base by writing computer program and entering data Handle Autocad, Microsoft word , Power point & Excel Responsible for Attending educational workshop; reviewing professional publications; establishing personal network; participating in professional socities. Prepare road map would be heading the engineering department. Responsible for any other assignment allocated by the department head.
Role & responsibilities Should have knowledge of SLD drawing Should be able to read the Electrical and Mechanical Drawing. Should be able to understand of P&ID and isometric Drawing. Basic knowledge of AutoCAD Hands on experience of Budget preparation of project work. Hands on experience on Project planning, handling and management. Should have able to manage material stock and record for consumption sheet preparation. Understand Companys Health & Safety Policy and follow all company HSE procedures. Should able to deliver the assigned task on time. Finalization of technical specification of machine Hands on experience on documentation like OQ,IQ,URS etc. Hands on experience of execution and commissioning of pharma machineries and utility Equipments Should have knowledge of HVAC system and clean room applications Should have knowledge of CGMP and revised schedule M Hand on experience of solid oral facility (Nutraceutical experience also be considered)Hands on Experience of WTP/utilities (Boiler, Chiller, WTP, Compressor, ETP, STP) piping, installation and commissioning. Hands on experience of vendor co ordination Should be able to present Project status/ reports and Daily work status/report. Manpower handling Hands on experience on Facility qualification, HVAC and Compressed Air Validation Provide technical input as required to ensure projects progress in line with their scope requirements. Support the development and completion of documentation in relation to purchasing, planning, implementation, commissioning and validation activities in relation to the above. Be responsible for Supervision of 3rd party contractors and internal service providers Be responsible for tracking and reporting project delivery, ensuring projects are delivered on time and within budget. Ensure training has been Given before undertaking specific duties and that all training is recorded in training records. Preferred candidate profile 5-7 years of hands-on experience in project engineering or project management roles within OSD pharmaceutical manufacturing . In-depth knowledge of OSD manufacturing processes , equipment, utilities, and facility layouts. Hands on Experience of HVAC system, cleanroom classification, and GMP /cGMP requirements. Hands-on experience with equipment installation, commissioning, and qualification (IQ/OQ/PQ).
Role & responsibilities Analysis of Routine and Stability samples using instruments like HPLC , UHPLC (Shimadzu), GC.UV spectrophotometer, IR, KF titrator and Dissolution tester. Having Experience in handling of Instruments, Like Analytical Balance, pH meter, KF Titrator, UV spectrophotometer, HPLC, UHPLC, Dissolution tester, GC is preferable Perform Calibration of instruments or equipment Like HPLC, Dissolution. Understanding of wet chemical analysis like: Titration, LOD, KF , IR, UV etc. Maintain analytical documentation records and online documentation of experiments. Understanding of analytical method development Activity. Execute routine Analytical research activities of drug products Follow GLP and safety in the laboratory as per regulatory guidelines. Responsible for any other assignment allocated by the Department Head.
Role & responsibilities The Engineering Manager will direct and coordinate all engineering activities within the company's flagship pharmaceutical manufacturing facility, including equipment maintenance, project management, and process validations to ensure overall plant goals and objectives are accomplished. Being the Lead Manufacturing Engineer for the Engineering Department, ensuring best practice processes are developed. Providing Manufacturing Engineering support to both customers and suppliers Identifying and implementing improvements to equipment, processes and methods Identifying and driving improvement initiative to reduce costs and improve on time delivery Provide technical assistance to the engineering team to ensure equipment issues are addressed Assure proper documentation of technical data generated for the assigned projects and/or tasks consistent with engineering policies and procedures Maintain accurate and secure records for all engineering maintenance activities performed and to ensure that they are performed as per schedule
Role & responsibilities 1. Documentation Issuance & Control - Issue Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and logbooks to production as per SOP. - Maintain master documents for BMR, BPR, SOPs, and other controlled documents with proper version control. - Implement and maintain document control systems as per GDP and cGMP requirements. 2. Batch Record Review & Compliance - Review executed BMR and BPR for completeness, accuracy, and compliance with approved specifications. - Coordinate with production to resolve discrepancies, deviations, and documentation errors. 3. SOP & Change Control - Assist in preparation, review, and revision of SOPs related to QA and documentation practices. - Support change control, deviation, and CAPA processes related to documentation. 4. Audit & Regulatory Support - Ensure readiness for internal and external audits by maintaining accurate documentation. - Provide necessary documents and records during inspections (USFDA, WHO, MHRA, etc.). 5. Training & Coordination - Train production and QA staff on Good Documentation Practices (GDP) and documentation SOPs. - Coordinate with other departments for timely closure of documentation requirements. 6. Data Integrity & Archiving - Ensure compliance with data integrity principles in all document handling activities. - Maintain systematic archival of controlled documents for easy retrieval and regulatory compliance.
Role & responsibilities 1. Microbiological Analysis - Conduct microbial limit test, sterility test, endotoxin testing, and bioburden analysis on raw materials, in-process, and finished products. - Perform water testing for purified water and potable water systems as per pharmacopeial standards. - Conduct environmental monitoring of cleanrooms and controlled areas, including settle plates, active air sampling, and surface monitoring. 2. Documentation & Compliance - Prepare and review analytical reports, logbooks, and records in line with GDP (Good Documentation Practices). - Ensure compliance with GMP, WHO, USFDA, MHRA, and other regulatory guidelines. - Handle SOP preparation, revision, and adherence for microbiology operations. 3. Equipment Handling & Calibration - Operate and maintain autoclaves, LAF, incubators, BOD chambers, particle counters, and microbiological instruments. - Ensure timely calibration and qualification of instruments. 4. Quality & Investigation - Support OOS (Out of Specification), OOT (Out of Trend), and deviation investigations related to microbiological testing. - Assist in CAPA implementation for microbiology-related observations. 5. Training & Safety - Provide training to junior team members on microbiology practices and SOPs. - Follow and enforce safety guidelines for handling microbial cultures and hazardous materials. Key Skills & Competencies: - Strong knowledge of pharmacopeial methods (IP, BP, USP, EP) and cGMP guidelines. - Hands-on experience with microbial testing techniques and environmental monitoring. - Good understanding of sterile and non-sterile product testing requirements. - Analytical mindset, attention to detail, and good documentation skills. - Ability to work in team environment and handle regulatory audits confidently.
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