236 Api Manufacturing Jobs - Page 3

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Required Candidate profile Lead handling of Quality Management System (QMS) activities: deviations, change controls, CAPAs, OOS/OOT, and risk assessments. Immediate to 30 days preferred

Ensure compliance with cGMP, ICH, and regulatory guidelines in API manufacturing. Review and approval of master batch manufacturing records (MBMR) and batch packing records (BPR). Conduct in-process checks and ensure batch release activities. Required Candidate profile Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.). Review of analytical documents, stability protocols, validation protocols & reports. Immediate to 30 days preferred

Roles and Responsibilities ONLY FOR MALE CANDIDATES Prepare and review batch records for API production runs. Collaborate with cross-functional teams to resolve issues related to product development and manufacturing. Maintain accurate records of test results, inventory management, and equipment maintenance.

M.Sc. - Organic Chemistry with 5 to 8 years of experience in Pharma Manufacturing Industries. Having Pharma Company experience in APIs & their Intermediates. Literature Search via Scifinder, chemical abstract, Free Patent online & Journals. Required Candidate profile Communication with IPR & Regulatory Affairs & DQA Dept. Development with Extraction, Purification & Distillation of product. Preparation of Process safety report & data analysis of Intermediate & APIs Perks and benefits Negotiable - Depending Upon Candidate & Experience

Role & responsibilities Stage wise inspection for fabrication activity (inhouse) for pressure vessel, column, heat exchanger, storage tank & reactor vessel etc. As PER ASMD CODE SEC. Viii inspection of pipe, tube & fittings as per ASTM / ASME - SEC. II DIV. A/B inspection of valves - gate / globe / check / ball valves etc. As per astm a370, & api 598, API 600 / API 6D. Inspection of pumps as PER API STD. 610- centrfugal pump, & API 675 - positive displacement pump. Site work experience - welding of pipeline qualification as PER API STD. 1104 / ASME sec. Xi & pipeline welding radiography reviewed & final hydrotest of pipeline. Production & expedite work of fabrication equipment & required documentation as per thirdparty inspection. Designing of details fabrication equipment drawing and inspection of fabrication equipment and materials at workshop. Job also involve inspection of civil, paints, electrical installation etc. Preferred candidate profile Perks and benefits

Position: Sr. Executive / Manager - Civil Engineer Grade: G11A / G11B No. of Position: 1 No. Job Location: Ahmednagar Qualification: B. E. (Civil) Experience: 9 to 12 yrs experience in Engineering (Civil) of API manufacturing plant Job Profile To collect data for construction features as per the requirements of new projects and plan maintenance. Checked and approved drawings, method statements, material approvals, and technical specifications, standards etc. required for the project and maintenance as applicable Checking of RCC structure and norms, building finishes, installation and material finishes such as Clean room partition, PU & Epoxy flooring, RCC Zero level flooring, Brick work, Plaster, gypsum punning, False ceiling, aluminium doors and windows, floor, tiles, painting and all other architectural finishes related to building construction Project and Plant modification planning and execution Co-ordination with consultant, site contractor and other departments to the execution of work Preparing Budget and Estimates for Projects and other modification related activities Preparing BOQ of Civil and finishing work as per drawing Indenting purchase request for the civil and building finishing related work and coordination with purchase team for the purchase order effectively Allocation of work to sub-ordinates and contractor as per the priorities. Mobilize civil and finishing team as per works. Checking of measurement and billing related activity fir the civil work. To update all plants floor layout / drawing as per plant modification and project change controls. To prepared and submit required documents and drawing for licensing purpose with government and regulatory agency. Planning of preventive maintenance of building & facility for execution of plant maintenance work.

Position: Officer / Sr. Officer - Quality Control Grade: G12C / G12B No. of Position: 1 No. Job Location: Ahmednagar Qualification: M. Sc. (Chemistry) Experience: 5 to 9 yrs experience in API manufacturing plant Job Profile To investigate LAB Event, OOS/OOT results, Un-Planned deviation, Planned Deviation in all Section and timely submit for approval. To prepare and review the laboratory investigation report hypothesis study / evaluation study protocol and reports. To review of Analytical data like packing material, In-Process samples, Intermediate samples, Raw material and Finished Product samples, Stability samples etc. To review of instruments log books and other log books like IC Column, LCMS Column and WRS Log books etc. To ensure effective review of physical and electronic raw data and records generated in QC laboratory Review sample set and instrument methods, custom field related activity in Empower 3 software To review Audit trail of laboratory instrument which are connected with software like EMPOWER, LAB X, LAB Solution etc. To co-ordinate and conduct self inspection (internal audit) and its compliance To execute and review change control proposals in TRACK WISE. To monitor the compliance with the requirements of Good Manufacturing Practice and Good laboratory practice. To participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement. To ensure a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management. To conduct training program and ensure its effectiveness To Co-ordinate and manage with other department of the plant to build continuous quality in product and systems with technical support to get customer satisfaction. To co-ordinate with contract laboratory and full fill the requirements as per responsibilities section in technical / quality agreement and extend support as per requirements.

Supervise & coordinate packaging activities Prepare & maintain documentation Ensure adherence to safety and quality standards Maintain & troubleshoot packaging equipment Train and develop packaging staff Experience in a packaging in API industries

Supervise & coordinate packaging activities Prepare & maintain documentation Ensure adherence to safety and quality standards Maintain & troubleshoot packaging equipment Train and develop packaging staff Experience in a packaging in API industries

As the leading international supplier of active pharmaceutical ingredients (APIs), we at TAPI take pride in our extensive portfolio of over 350 API products and our reputation as a trusted partner for 80% of the top 50 global pharmaceutical companies. With a history dating back over 80 years, we have established ourselves as industry leaders through our experience, expertise, technologies, and exceptional customer service. Our success is driven by our dedicated team of over 4,000 professionals spread across 14 sites worldwide, with state-of-the-art production facilities in multiple countries. We are committed to continuous innovation and investment in research and development to ensure a steady flow of high-quality APIs and the timely introduction of new products to the market. In this role, you will be responsible for various aspects of product transfer, scale-up, proposals, Capex evaluations, and process engineering calculations. Your key tasks will include improving the yield, efficiency, and cost effectiveness of developed APIs by introducing new technologies, troubleshooting plant-related problems, and contributing novel ideas during technical discussions. Additionally, you will be involved in cycle time reduction, capacity enhancement, and coaching and developing a team of engineers to drive performance and engagement. The ideal candidate will have a solid background in API manufacturing, with a deep understanding of scale-up processes and experience in handling CDMO products. You should possess expertise in chemical process unit operations, Quality by Design, process safety, technology transfer, and commercial production. Strong communication, project management, and supervisory skills are essential for collaborating effectively with internal teams and external stakeholders. To qualify for this role, you should hold a B.Tech/M.Tech in Chemical Engineering from a reputable institute and have 14-16 years of experience in the field, including at least 5 years in people management. Your ability to handle multiple projects simultaneously, troubleshoot issues, and use process modelling tools will be critical for success in this position. If you are a proactive, detail-oriented professional with a can-do attitude and a passion for driving excellence in API manufacturing, we invite you to join our team at TAPI and play a key role in our mission to deliver high-quality pharmaceutical ingredients to the global market. This position reports to the Associate Director, MS&T.,

Role & responsibilities To observe lab experiments during lab demonstration at optimization stage and suggest Negative experiment based on plant equipment and feasibility. Preparation of process summary, volume calculation, Mass balance, utility load, effluent load and costing. To identify and propose new ideas & technology to improve process efficiency, smooth unit operation/unit processes and effective utilization of resources To identify recovery and reuse of solvents. Ensure right equipment selection as per process requirement. Suggest required modification in equipment as per process requirement. Support the external job work activity to achieve desired yield & quality. Coordinate with Cross Function Department Like Production, R&D, maintenance and QA to smooth line the technology transfer. Handle equipment safely during operation, maintenance, and shutdowns by following established procedures. Collaborate with cross-functional teams to implement process safety improvements through scale up and capacity enhancement initiatives. Perform risk assessments to evaluate the severity of identified hazards and develop mitigation strategies. Conduct HAZOP studies to identify potential hazards in processes and equipment.

To understand, communicate and prepare a system to meet the desired production of each product as per the plan agreed by SCM team. To manufacture all products of high quality by complying with CGMP and safety systems at Udaipur Plants. Required Candidate profile Sound good knowledge of Sterile API.

Hi, Greetings from Avani Consulting!! We have job opportunities with API Manufacturing Plant for the Production Associate/Sr Associate position, Mysore Location. Job Description: Production Department Position- Associate/Executive Work Experience - +4 in API Manufacturing Location - Mysore Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by Production head. If interested, kindly send your updated resume on whatsapp @ 7327039030 with the below details 1. Current CTC: 2. Expected CTC: 3. Notice Period: 4. Current Location: 5. Preferred Location: 6. Total Experience: 8. Relevant Experience in Production Process: 9. Experience in API Manufacturing: 10. Current company: 11. Qualification: 12. Experience in Documentation: 13. Reason for change: Thanks & Regards Monalisa Barik

Lead and manage API research and development projects from conceptualization to commercialization.Oversee process development, optimization, and scale-up activities.Guide documentation for DMFs, dossiers, and patent evaluations. Required Candidate profile M.Sc (Organic Chemistry)/M. Pharma with 15–20 years of experience OR Ph.D. (Chemistry) with 8 years of hands-on R&D experience in API development. Deep knowledge of regulatory and cGMP requirements.

Role & responsibilities To receive operating instructions for the shift from Production Executive products. Ensure batch processing is carried out strictly in accordance with batch records and as instructed. Operates the process ensuring that all parameters are strictly followed and are within the specified limits. Responsible for maintaining Good House Keeping in all the areas of Production department. Ensure that the equipment's are always clean from outside. Follow GMP and Safety Instructions during the work. Ensure use of appropriate safety apparels while on work and should be aware of the location of fire fighting equipment and know operation. Shall be responsible for operating all the utilities, equipment's as per the operating instructions and ensure that the process parameters are strictly followed. Report immediately to the Executive / Officer any deviations observed during the operation. Preferred candidate profile We are looking for Male candidates to work for API Manufacturing industry . Current openings : 40Nos Designation : Freshers - BSC in chemistry / Diploma in chemical engineering only Junior officer : BSC in chemistry / Diploma in chemical engineering only Officer & Executive : BSC/MSC, BTech in Chemical Engineering Experience required : 0 to 5 years Any query ? Please reach out ramya_n@hikal.com

Position: Jr Officer Engineering - Instrumentation Grade: G13 No. of Position: 1 No. Job Location: Ahmednagar Qualification: B.E. (Instrumentation) Experience: 4 to 5 yrs experience in Engineering (Instrumentation) of API manufacturing plant Job Profile Attending the breakdown related to process and utility equipment. Handle SAP activities, Calibration of manufacturing activities etc. Handle and monitor maintenance activities of process equipment and utility equipment such as PLC, HMI, SCADA and all automation systems. Handle QMS activities in Trackwise such as Change control, Deviations etc.in engineering department, to perform and support engineering related investigations. Co-ordinate and face the audits such as regulatory audit, statutory audits, safety audits etc. Handle SAP activities, Calibration of manufacturing activities etc. To attend the duties as per shift schedule . To take care of PCS related activities and to take care CSV Validation activities.

Hi, Greetings from Avani Consulting!! We have job opportunities with API Manufacturing Plant for the Production Associate/Sr Associate position, Mysore Location. Job Description: Production Department Position- Associate/Executive Work Experience +7 in API Manufacturing Location Mysore Qualification: B.tech in Chemical// M.Sc Chemistry with 3 years in API Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by Production head. If interested, kindly send your updated resume on whatsapp @ 7015954549 with the below details 1. Current CTC: 2. Expected CTC: 3. Notice Period: 4. Current Location: 5. Preferred Location: 6. Total Experience: 8. Relevant Experience in Production Process: 9. Experience in API Manufacturing: 10. Current company: 11. Qualification: 12. Experience in Documentation: 13. Reason for change: Thanks & Regards Shweta Gupta

Responsibilities: * Conduct BMR reviews and approvals. * Ensure compliance with GMP, API manufacturing, IPQA standards. * Collaborate with production teams on batch releases. * Monitor product quality throughout lifecycle. Food allowance Provident fund Annual bonus

Job Title : Sr. Manager Purchase [APIs & Intermediates] Location : Gurugram Experience : 10-20 years Key Responsibilities Strategic Procurement : Develop and execute procurement strategies for APIs and intermediates, ensuring alignment with production schedules and regulatory requirements. Vendor Management : Identify, evaluate, and establish relationships with reliable suppliers. Negotiate favorable terms and monitor supplier performance to ensure quality and timely delivery. Inventory Control : Oversee inventory levels of raw materials and intermediates, coordinating with production and warehouse teams to maintain optimal stock levels and prevent shortages. Quality Assurance : Ensure that all procured materials meet the required quality standards and comply with GMP (Good Manufacturing Practices) regulations. Budget Management : Develop and manage the procurement budget, tracking spending and identifying cost-saving opportunities. Regulatory Compliance : Stay updated on industry regulations and ensure all procurement activities comply with legal and company standards. Team Leadership : Lead and mentor the procurement team, fostering a collaborative and high-performance work environment. Qualifications Education : Bachelors degree in Pharmacy, Chemistry, or a related field. A Masters degree or MBA is preferred. Experience : Minimum of 10-15 years in procurement within the pharmaceutical industry, with at least 5-6 years in a leadership role. Skills : Strong negotiation and vendor management skills. In-depth knowledge of API manufacturing processes and regulatory requirements. Proficiency in procurement software and ERP systems. Excellent communication and interpersonal skills. Ability to analyze market trends and make informed purchasing decisions. Preferred Experience Experience in handling procurement for APIs and intermediates in compliance with GMP and other regulatory standards. Familiarity with the pharmaceutical supply chain and logistics. Proven track record of cost reduction and process optimization in procurement.

Role & responsibilities Plant Leadership: Serve as the Unit Head, leading all production activities and ensuring efficient, compliant, and safe operations of the Hormonal API facility. Production Management: Oversee daily operations including batch execution, shift planning, manpower deployment, and material availability for smooth production. GMP & Regulatory Compliance: Ensure strict adherence to cGMP, EHS, and regulatory standards (USFDA, WHO, EDQM, etc.). Prepare and face regulatory inspections. Process Optimization: Drive continuous improvement initiatives to enhance productivity, reduce downtime, and improve yield & quality. Cross-functional Coordination: Collaborate with QA, QC, Engineering, SCM, and Regulatory teams to ensure seamless operations. Team Development: Build and nurture a high-performing team. Train and mentor staff on SOPs, safety practices, and technical knowledge. Project Handling: Participate in capacity expansion projects, equipment qualification, technology transfer, and validation activities. Preferred candidate profile Educational Background: B.Tech (Chemical) / M.Sc Experience: 1825 years of experience in API manufacturing, with at least recent 5 years in Hormonal / HPAPI production Skills: Strong leadership, production planning, regulatory exposure, team handling, and problem-solving abilities Location: Willing to work full-time at Yadagirigutta

Job Overview The Peptides Production Manager will oversee and manage the end-to-end production activities for peptide synthesis, ensuring timely delivery, compliance with quality standards, and adherence to regulatory requirements. The role involves process optimization, team management, and collaboration across departments to achieve production targets effectively and efficiently. Key Stakeholders: Internal Quality, R D, Engineering and support functions. Key Stakeholders: External Vendors and Customers on need basis Reporting Structure This position will report to Chief Manager Production Experience Min 10 to 15 years experience with peptide API manufacturing for regulated markets. Competencies Strong knowledge of peptide synthesis techniques (solid-phase/liquid-phase synthesis).. Clear communication. Analytical mindset. Quick and effective decision making. Stakeholder management. Key Roles/Responsibilities: Develop and implement production plans in line with business objectives. Ensure timely execution of production schedules for peptide synthesis, purification, and formulation. Monitor production metrics to achieve efficiency, yield, and throughput targets. Evaluate and improve manufacturing processes to enhance productivity and cost-effectiveness. Implement best practices for peptide synthesis Troubleshoot and resolve process deviations or bottlenecks. Ensure adherence to cGMP, ISO standards, and regulatory guidelines in all production activities. Maintain complete and accurate batch records and documentation. Lead, train, and motivate the production team, fostering a culture of continuous improvement. Implement and maintain EHS protocols in the production facility Qualifications B E Chemical/ M.Sc./ Ph.D/ B.Sc. + MBA/with relevant experience.

Job Overview The Peptides Production Manager will oversee and manage the end-to-end production activities for peptide synthesis, ensuring timely delivery, compliance with quality standards, and adherence to regulatory requirements. The role involves process optimization, team management, and collaboration across departments to achieve production targets effectively and efficiently. Key Stakeholders: Internal Quality, R & D, Engineering and support functions Key Stakeholders: External Vendors and Customers on need basis Reporting Structure This position will report to Chief Manager Production Experience Min 10 to 15 years experience with peptide API manufacturing for regulated markets. Competencies Strong knowledge of peptide synthesis techniques (solid-phase/liquid-phase synthesis). . Clear communication. Analytical mindset. Quick and effective decision making. Stakeholder management. Roles and Responsibilities: Develop and implement production plans in line with business objectives. Ensure timely execution of production schedules for peptide synthesis, purification, and formulation. Monitor production metrics to achieve efficiency, yield, and throughput targets. Evaluate and improve manufacturing processes to enhance productivity and cost-effectiveness. Implement best practices for peptide synthesis Troubleshoot and resolve process deviations or bottlenecks. Ensure adherence to cGMP, ISO standards, and regulatory guidelines in all production activities. Maintain complete and accurate batch records and documentation. Lead, train, and motivate the production team, fostering a culture of continuous improvement. Implement and maintain EHS protocols in the production facility Qualifications B E Chemical/ M.Sc./ Ph.D/ B.Sc. + MBA/with relevant experience

We are looking for skilled Automation Engineers with experience in pharmaceutical projects and hands-on involvement in DCS and PLC-based industrial automation systems . The ideal candidate should be familiar with various communication platforms , automation technologies , and GAMP protocols . Key Responsibilities: Execute and manage automation projects in pharmaceutical environments. Design, configure, and implement DCS systems for process automation. Work with industrial communication protocols (e.g., Modbus, Profibus, Ethernet/IP). Ensure compliance with GAMP guidelines and validation processes. Collaborate with cross-functional teams for project execution and documentation. Participate in FAT/SAT and provide technical support during commissioning. Desired Candidate Profile: Bachelors degree in Instrumentation, Electronics, or related engineering field. 4+ years of experience in pharmaceutical automation projects. Hands-on experience with DCS/PLC systems (e.g., Siemens, Rockwell, ABB). Familiarity with SCADA/HMI systems and GAMP protocols. Strong analytical and troubleshooting skills. Good communication and team collaboration abilities.

We are looking for an experienced and detail-oriented Quality Assurance (QA) professional to oversee and maintain the quality management system and ensure compliance with statutory and customer standards. Responsibilities: Prepare and maintain all quality manuals, process documents, and standard operating procedures (SOPs). Review and approve process, quality control, maintenance manuals, and batch/lot releases. Investigate deviations, failures, non-conformances, out-of-specification results, and customer complaints; implement corrective and preventive actions (CAPA). Ensure calibration and maintenance of all instruments and test equipment used for inspection and testing. Ensure compliance with statutory and regulatory standards such as ISO and other applicable guidelines. Oversee validation of processes, analytical methods, and equipment, and review validation reports. Approve analytical reports for finished products, ensuring conformity to standards and customer specifications. Maintain proper control over the use of product labels in line with statutory requirements. Ensure proper inspection and test status of all materials in accordance with laid-down procedures. Conduct internal audits for quality systems, monitor corrective actions, and ensure closure. Conduct training programs to enhance quality awareness among staff. Desired Candidate Profile: Proven experience in quality assurance/quality control in [insert industry, e.g., pharma, FMCG, etc.]. Strong knowledge of quality management systems, ISO standards, GMP/GLP compliance. Excellent problem-solving, analytical, and communication skills. Ability to lead internal audits and drive a culture of quality compliance.

To Maintain production activities following cGMP. Responsible for online documentation. Responsible for issuance of Raw material /Packing material. Responsible to follow all cGMP requirements related production activity. Required Candidate profile Responsible to manpower handling & co-ordination with departments like QC, QA , Maintenance, Finished Product store etc.