342 Api Manufacturing Jobs

The ideal candidate should have at least 3 years of experience of working in Pharmaceutical Production floor where the person is responsible for shift operations. The incumbent would typically be responsible for: Ensuring the targets are met keeping in mind safety and quality guidelines. Management and upkeep of facility, materials and manpower. Troubleshooting in operations, validations and equipment qualification Coordination with other functions like QC, QA, Warehouse among others. Knowledge and Adherence to SOPs , regulatory requirement Preparing Batch Manufacturing Records, Protocols, Reports, Investigation Reports, and Qualification Reports. Work on Continuous improvement Plans (like Capacity and Manpower Utilization, Product Cost Effectiveness, Effluent Control and Safety Improvement, etc.)

R&D Chemist at Panoli Plant, Gujarat – Develop & optimize chemical formulations, conduct lab trials, ensure compliance, drive innovation, support patents, and collaborate across teams to deliver sustainable, cost-effective, customer-focused solutions

Roles & Responsibilities not limited to: 1.HR Generalist & Administration 2.Legal & Statutory Compliance 3.Industrial & Public Relation 4.Local Liasioning 5.Recruitment 6. GPCB & GIDC. Note: Please share your updated CV on pooja.thakur@embio.co.in

The Production Chemist will be responsible for executing and monitoring API manufacturing processes, ensuring compliance with cGMP, SOPs, and regulatory guidelines . The role involves operating chemical process equipment, documentation, troubleshooting, and process optimization to achieve efficiency, safety, and quality standards. Key Responsibilities & Duties: Process Execution: Perform batch manufacturing activities in line with Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and cGMP requirements. Equipment Operation: Operate and monitor reactors, centrifuges, multi-mill, shifter, tray dryer, filtration systems, GLR, and SSR equipment . Quality Assurance & Compliance: Coordinate with QA/QC teams for batch release, deviation handling, and ensure adherence to regulatory and quality standards . Documentation: Maintain accurate production records, logbooks, and deviation reports ensuring data integrity and audit readiness. EHS & Safety Compliance: Follow Environmental, Health & Safety (EHS) protocols, participate in safety drills, and ensure a safe work environment. Process Optimization: Assist in scale-up, yield improvement, and continuous improvement initiatives for cost-effective production. Troubleshooting & Maintenance: Identify and resolve equipment or process deviations in coordination with the engineering and maintenance teams . Shift Management: Supervise shift operations, allocate tasks, and ensure smooth production workflow. Qualifications & Experience Education: B.Sc./M.Sc. in Chemistry or B.E. in Chemical Engineering. Experience: 1 - 6 years in API production / pharmaceutical manufacturing . Technical Skills: Knowledge of GMP, GLP, ICH, and regulatory compliance . Hands-on experience with clean room operations, batch documentation, and shift planning . Familiarity with process safety, scale-up, and validation activities . Preferred Attributes Strong analytical, problem-solving, and decision-making skills . Ability to work effectively in a fast-paced, regulated production environment . Good communication, teamwork, and reporting skills . Flexible to work in shifts and handle multiple tasks.

This role is responsible for technology transfer, process scale-up, equipment selection, and process validation in API manufacturing. The position ensures that the selected equipment aligns with process requirements, product quality, safety, and regulatory compliance, while supporting continuous improvement and operational excellence. Key Responsibilities: 1. Technology Transfer & Scale-up Lead the transfer of chemical processes from R&D to manufacturing. Evaluate and optimize process parameters for scale-up using mass and energy balances. Collaborate with Engineering for facility fitment, equipment readiness, and plant execution. 2. Equipment Selection & Sizing Analyse process requirements (reaction type, pressure/temperature profile, mixing, solvent use, etc.) to recommend suitable equipment. Select and size reactors, centrifuges, dryers, heat exchangers, condensers, and other equipment based on: Reaction kinetics and thermodynamics Process safety and control requirements Material compatibility and GMP compliance Evaluate batch vs. continuous processing options. Ensure scalability, containment, cleanability, and GMP compliance. Review P&IDs and layouts with Engineering and Production teams. 3. Process Optimization & Validation Conduct trials for equipment qualification and process optimization. Prepare and execute process validation protocols and reports. Lead QbD, DoE, and Process Analytical Technology (PAT) initiatives. 4. Documentation & Compliance Prepare/review equipment specifications, MFRs, BMRs, risk assessments, and validation documents. Ensure adherence to ICH Q8Q11, cGMP, USFDA, EUGMP, and other global guidelines. Support data generation for DMF filings and regulatory responses. 5. Cross-functional Collaboration Coordinate with R&D, QA, QC, Production, Engineering, EHS, and Regulatory Affairs. Provide technical training to operations and quality teams. Participate in internal/external audits and ensure compliance. 6. Continuous Improvement & Troubleshooting Analyse deviations and implement process/equipment modifications. Identify bottlenecks and recommend process/equipment upgrades. Drive cost-saving and productivity initiatives through efficient process/equipment utilization. Required Qualifications & Skills Education: B.E./B.Tech/M.Tech in Chemical Engineering or M.Sc. in Chemistry. Experience: 7 - 10 years in Technical Services, Process Engineering, or API Manufacturing. Strong understanding of process engineering and equipment design principles. Proven hands-on experience in selecting equipment for reactions, crystallization, drying, and filtration. Proficiency in PFDs, P&IDs, and risk mitigation strategies for scale-up. Working knowledge of process simulation tools (Aspen, ChemCAD, etc.) preferred. Familiarity with cGMP, regulatory requirements, and process safety norms.

Job Title: API Marketing (West India) Location: Mumbai / Ahmedabad / Bangalore (as per candidate preference) Experience: Minimum 3 years in API Bulk Drug Sales & Marketing Job Description: We are looking for a passionate and result-oriented professional to join our API Marketing team for the West India region (Mumbai & Ahmedabad markets) . Key Responsibilities: Drive sales of APIs (bulk drugs) in the West India market. Identify, develop, and manage new and existing customer relationships. Achieve sales targets through effective market penetration and business development. Handle negotiations, contracts, and pricing discussions with clients. Coordinate with internal teams (R&D, Production, QA, Logistics) to ensure timely delivery and customer satisfaction. Track market trends, competitor activities, and provide inputs for business growth. Desired Candidate Profile: Graduate / Postgraduate in Science / Pharmacy / MBA (preferred). Minimum 3 years of experience in API bulk drug sales/marketing. Strong knowledge of the pharmaceutical / API industry. Excellent communication, negotiation, and interpersonal skills. Ability to work independently and drive business in assigned markets. Perks & Benefits: Competitive salary. Opportunity to grow with a leading pharmaceutical company. Exposure to domestic and clients. Email your resume to ramakrishna.r@globalcalciumpharma.com.

Job Title: Sr. Officer / Executive QA Business Unit: Global Quality & Compliance Job Grade G12B /G12C Location : Ahmednagar / Ahilyanagar At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Key responsibilities: Responsible for co-ordination, monitoring, tracking, participating, etc. in activities assigned for review or verification to ensure adequacy, completeness and compliance of documents, procedure, practices, etc. Review of Batch Manufacturing Record (BMR) and Equipment Cleaning Record (ECR) prior to release of batch in SAP HANA as per current approved procedures. To report Rejection/Failure observation immediately. Preparation and review of GMP documents related to activities. Release/Reject of material/batch in SAP HANA after ensuring related relevant documents and system related records through Trackwise about change control, deviation, Lab event, OOS, OOT closed etc. are closed prior to approval. Activities related to updation/transactions in SAP System Follow the labelling and seal issuance procedure for materials after release/ rejection of batches. Involved in dispatch activity and customer COA preparation/ to Verify certificate of analysis. Equipment, instrument and utilities etc. qualification and re-qualification protocol and report review for manufacturing section. To co-ordinate with change control team for the evaluation of change controls to refer for impact assessment and to derive action items. Review and closure of the change controls/action items in track-wise. To escalate or highlight problems in QMS documents, investigations, BMR, ECR and another document time to time. To involve in training, internal audits, external audits (Regulatory and customer). Preparation and review of product quality review (APOR/POR) and stated documents as per schedule, monthly report and as and when required Responsible for co-ordination, monitoring, tracking, participating etc in activities assigned for review verification to ensure adequacy, completeness and compliance of documents, procedure, To monitor, Tracking, review/closing of deviations, Out of specification, Investigation. Corrective and Preventive actions, Market complain, Change controls, etc to ensure adequacy in quality management system (QMS) Participation in various investigation processes (including cross functional investigation) to identify root cause and derive appropriate CAPA, etc. and closing the CAPA action/QMS documents Responsible for co-ordination, monitoring, tracking and review of documents related to validations like process performance qualification, cleaning validation, Matrix, continued process verification report, esc GMP Walk round in manufacturing plants, Quality Control Laboratory, stores, engineering as per schedule. Review of annual summary reports for water systems and annual summary reports for environmental monitoring Travel Estimate Job Requirements Educational Qualification M. Sc. (Organic Chemistry / Analytical Chemistry) Experience Tenure : 5 to 8 yrs experience in API manufacturing Units in Quality dept Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Job Title: Executive / Sr. Executive QA Business Unit: Global Quality & Compliance Job Grade G12A / G11B Location : Ahmednagar / Ahilyanagar At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Key responsibilities: Responsible for co-ordination, monitoring, tracking, participating, etc. in activities assigned for review/verification to ensure adequacy, completeness and compliance of documents, procedure. practices, etc. To monitor, tracking, review & closure of deviations, Out of specification, Investigations. Corrective and Preventive actions, Market complaint. Change controls, etc. to ensure adequacy in quality management system (QMS). Ensure effective implementation of Quality Management system at site and to monitor QMS activities in Track wise software. To escalate or highlight problems in QMS document and investigation in time. Review of data with evaluation to support of QMS documents like Change controls, deviations, CAPAS, OOS, Laboratory Events & monitoring of Preventive Maintenance, qualification etc. Responsible for co-ordination, monitoring, tracking and review of documents related to validations like process performance qualification, cleaning validation, Matrix, continued process verification report, etc. To provide the required details/data related to QMS for the preparation of APQR, monthly report and as and when required. Preparation/review of APQR Preparation/guidance and review of Quality Risk Management evaluation of risk involved in manufacturing activities, received / manufactured material, related to audit compliance, failure/gaps of existing system, activities related to laboratory controls, etc. Review of change controls received from different departments (viz. process, equipment, facility. SOP, specification, etc. ) for its appropriate evaluation, justification and its classification to identify and communicate the action items derived based on the assessment to all the concern wake holder through Trackwise. Providing the status of QMS records like change controls, deviations, etc. as an when required to management through Quality metrics, data gathering, etc and to conduct the meeting for its progress and timely closure. Coordinating and reviewing technology transfer activity and ensuring availability of required documents as per respective SOP Review of Batch Manufacturing Record (BMR) and Equipment Cleaning Record (ECR) prior to release of batch in SAP HANA as per current approved procedures. Release Reject of material batch in SAP HANA after ensuring related relevant documents and system related records through Trackwise about change control, deviation, Lab event, OOS, OOT closed etc. are closed prior to approval. Activities related to updation/ transactions in SAP System Perform the product change over clearance activity in manufacturing, packing/repacking area. To operate various software such as Trackwise, SAP, LIMS, BRMS, EDAMS, EDMS etc. Travel Estimate Job Requirements Educational Qualification M. Sc. (Organic Chemistry / Analytical Chemistry) Experience Tenure : 7 to 9 yrs experience in API manufacturing Units in Quality dept Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Job Title: Executive / Sr. Executive QA Business Unit: Global Quality & Compliance Job Grade G12A / G11B Location : Ahmednagar / Ahilyanagar At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Key responsibilities: Responsible for co-ordination, monitoring, tracking, participating, etc. in activities assigned for review/verification to ensure adequacy, completeness and compliance of documents, procedure. practices, etc. To monitor, tracking, review & closure of deviations, Out of specification, Investigations. Corrective and Preventive actions, Market complaint. Change controls, etc. to ensure adequacy in quality management system (QMS). Ensure effective implementation of Quality Management system at site and to monitor QMS activities in Track wise software. To escalate or highlight problems in QMS document and investigation in time. Review of data with evaluation to support of QMS documents like Change controls, deviations, CAPAS, OOS, Laboratory Events & monitoring of Preventive Maintenance, qualification etc. Responsible for co-ordination, monitoring, tracking and review of documents related to validations like process performance qualification, cleaning validation, Matrix, continued process verification report, etc. To provide the required details/data related to QMS for the preparation of APQR, monthly report and as and when required. Preparation/review of APQR Preparation/guidance and review of Quality Risk Management evaluation of risk involved in manufacturing activities, received / manufactured material, related to audit compliance, failure/gaps of existing system, activities related to laboratory controls, etc. Review of change controls received from different departments (viz. process, equipment, facility. SOP, specification, etc. ) for its appropriate evaluation, justification and its classification to identify and communicate the action items derived based on the assessment to all the concern wake holder through Trackwise. Providing the status of QMS records like change controls, deviations, etc. as an when required to management through Quality metrics, data gathering, etc and to conduct the meeting for its progress and timely closure. Coordinating and reviewing technology transfer activity and ensuring availability of required documents as per respective SOP Review of Batch Manufacturing Record (BMR) and Equipment Cleaning Record (ECR) prior to release of batch in SAP HANA as per current approved procedures. Release Reject of material batch in SAP HANA after ensuring related relevant documents and system related records through Trackwise about change control, deviation, Lab event, OOS, OOT closed etc. are closed prior to approval. Activities related to updation/ transactions in SAP System Perform the product change over clearance activity in manufacturing, packing/repacking area. To operate various software such as Trackwise, SAP, LIMS, BRMS, EDAMS, EDMS etc. Travel Estimate Job Requirements Educational Qualification M. Sc. (Organic Chemistry / Analytical Chemistry) Experience Tenure : 7 to 9 yrs experience in API manufacturing Units in Quality dept Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Job Title: Sr. Executive Maint. Engg. Business Unit: Global API Business Job Grade G11B Location : Ahmednagar / Ahilyanagar At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Key responsibilities: Attend the breakdown as per memos from various department. Monitor, track and perform scheduled maintenance activities such as preventive maintenance through SAP, earthing maintenance, alarm verification as per schedule. Attend all types of breakdowns related to process and utility equipment. Internal customer satisfaction by timely problem solving and maintenance OPEX control and inventory management, up keeping the diesel records, electrical spare records etc. Handle and monitor maintenance activities of process and utility equipment such as Transformers, DG Sets, PCC, MCC panels etc. Co-ordinate and face the audits from electrical department such as regulatory audit, statutory audits, safety audits etc. Prepare BOQ for the projects, monitor and support the execution according to planning. Analysis of parameters such as power consumption, utility reports etc. Raise the indents for electrical spares and consumables. Prepare the returnable and non-returnable gate pass as per requirement. Preparation of preventive maintenance schedule / calendar. Perform IQ, OQ and PQ qualifications of equipment. Travel Estimate Job Requirements Educational Qualification B. E. (Mechanical) Experience Tenure : 8 to 10 yrs experience in API manufacturing. Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Job Summary We are seeking a dynamic and experienced Scientist in Process Engineering in Active Pharmaceutical Ingredient (API) development with proven expertise in scaling up or down technologies to meet production demands. Proficient in Process and Chemical Engineering, adept at troubleshooting complex projects, facilitating technology transfer, and optimizing operations. Roles & Responsibilities You will be responsible to review of journals and patents. You will be responsible for feasibility study of the Process, Process Optimization,Lab Validations, Technology Transfer to plant and identify and evaluate the reaction parameters You will be responsible for staying up to date with relevant scientific and technical developments. Execute experiments efficiently with high reproducibility. You will be responsible for interpretation of analytical and spectral data to ensure quality and regulatory compliance. You will be responsible to write technical development reports, Quality by Design (QbD) reports, justification reports and Drug Master Filing (DMF) filing related documents. You will be responsible to provide support in scale up batches execution and ensure process reproducibility at scale. You will be responsible for ensuring lab safety and process safety. Qualification Educational qualification: M.Sc/ M.Pharma Minimum work experience: 3-5 years of Experience in API Manufacturing Skills & attributes: Technical Skills Have work experience on Process scale up of Active Pharmaceutical Ingredients. Experience in Process Optimization (Manufacturing) Experience in Process Intensification Experience in Operational Excellence Experience in Chemical Process Engineering Experience in Technology Transfer Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

We seek a meticulous EHS Officer to champion environmental health and safety initiatives at Acharya Group. This role is pivotal in ensuring compliance, mitigating risks, and fostering a safe working environment across our Morivali (Ambernath) and Dombivili locations. Candidates from Navi Mumbai, Thane, and Mumbai Suburbs are encouraged to apply. The EHS Officer will be responsible for implementing and maintaining EHS programs, conducting risk assessments, leading accident investigations, and delivering comprehensive EHS training. A successful candidate will possess a Bachelor's degree in Chemical Engineering or a related field, coupled with 1-2 years of experience in EHS within the API pharmaceutical , chemical, or petrochemical industries. Core technical skills include proficiency in risk assessment, HAZOP, HIRA, and a strong understanding of EHS legal requirements from DISH, MPCB, and CPCB. Essential soft skills include strong communication and problem-solving abilities. This role offers the opportunity to significantly impact workplace safety, contribute to continuous improvement in EHS practices, and collaborate with cross-functional teams to achieve EHS excellence. If you are passionate about creating a safe and sustainable work environment and thrive in a dynamic manufacturing setting, we encourage you to apply. Responsibilities EHS Program Implementation and Management Implement and maintain the company's EHS programs and policies in compliance with regulatory requirements. Develop and update EHS manuals, procedures, and guidelines to ensure they align with current best practices and legal standards. Monitor and evaluate the effectiveness of EHS programs through regular audits, inspections, and performance reviews. Collaborate with department heads to integrate EHS considerations into operational planning and decision-making processes. Maintain accurate records of EHS activities, including incident reports, training records, and inspection findings. Ensure compliance with all applicable environmental permits and licenses, including those related to air emissions, water discharge, and waste management. Risk Assessment and Hazard Management Conduct comprehensive risk assessments, including HAZOP and HIRA studies, to identify potential hazards and implement appropriate control measures. Develop and implement a robust Work Permit System to control hazardous activities and ensure safe work practices. Oversee the management of hazardous materials, including storage, handling, and disposal, in accordance with regulatory requirements. Conduct regular safety inspections to identify potential hazards and ensure compliance with safety standards. Evaluate and recommend appropriate Personal Protective Equipment (PPE) for various work tasks. Implement and maintain a comprehensive Process Safety Management (PSM) program to prevent catastrophic releases of hazardous chemicals. Incident Investigation and Reporting Lead and conduct thorough accident investigations to determine root causes and implement corrective actions to prevent recurrence. Prepare detailed incident reports, including findings, conclusions, and recommendations for improvement. Track and analyze incident data to identify trends and patterns, and develop proactive measures to address underlying issues. Communicate incident findings to relevant stakeholders, including management, employees, and regulatory agencies. Maintain a system for tracking the implementation of corrective actions and verifying their effectiveness. Ensure compliance with all applicable reporting requirements for workplace injuries, illnesses, and environmental releases. EHS Training and Awareness Develop and deliver comprehensive EHS training programs for all employees, covering topics such as hazard communication, PPE usage, and emergency response. Conduct regular safety meetings and toolbox talks to reinforce EHS principles and promote a culture of safety. Create and distribute EHS awareness materials, such as posters, newsletters, and videos, to keep employees informed and engaged. Conduct mock drills and emergency response exercises to test the effectiveness of emergency plans and procedures. Provide specialized training for employees working with hazardous materials or performing high-risk tasks. Maintain accurate records of employee training and certifications. Regulatory Compliance and Auditing Stay up-to-date on all applicable EHS regulations and standards, including those from DISH, MPCB, and CPCB. Conduct regular EHS audits to assess compliance with regulatory requirements and company policies. Prepare for and participate in external EHS audits conducted by regulatory agencies or third-party organizations. Develop and implement corrective action plans to address any deficiencies identified during audits. Serve as the primary point of contact for EHS-related inquiries from regulatory agencies. Manage the company's environmental permits and licenses, ensuring timely renewal and compliance with permit conditions.

Greetings! I am Priyanka. We are hiring QA Trainee / Officer Off roll for A leading API Manufacturing Company. Designation: 1. QA Officer/ trainee Off Roll Salary : Take way home [no benefits. no deduction] Location: Mysore Looking forward to hear from you. Note: No Charges Thanks & Regards Priyanka [ 9518220852 || priyanka@avaniconsulting.com ]

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.

Role & responsibilities Provide Support to routine analysis of API Synthesis R&D and Stability samples. Documentation of Daily analysis in corresponding product LNB. Development of analytical methods for drug substances, raw materials and intermediates. Perform AMV, AMDR, AMT activities. Preparation of Analytical method validation / AMT protocol & report. Preparation of Tentative STP/MOA during Development. Trouble shooting at the time instrument operation and analytical method related problem. Preparation of COA, MOA and provide to LIMS. HPLC and GC Calibration and Documentation and provide GLP for the same. Prepare method development report. Analytical method transfers and Documentary Methods Transferring new analytical techniques to Quality control. Development and validation of cleaning method for drug substance

Job Description Join Lupin Limited in the role of Junior Officer within our Quality division, specializing in Validation activities. This position is integral to ensuring the highest standards in cleaning validation processes for Active Pharmaceutical Ingredient (API) facilities. Your primary responsibility will involve managing and executing comprehensive cleaning validation protocols to guarantee product safety and regulatory compliance. Key responsibilities include: Conducting residue cleaning validation to verify the removal of contaminants from manufacturing equipment. Performing nitrosamine cleaning validation to monitor and control genotoxic impurities in line with current global regulatory expectations. Carrying out genotoxic cleaning validation studies to assess and mitigate the risk of harmful agents. Calculating Risk Priority Numbers (RPN) as part of Failure Mode and Effects Analysis (FMEA) to evaluate and prioritize risks in cleaning processes. Executing Campaign Effectiveness and Hold Time (CEHT) and Degradation Effectiveness and Hold Time (DEHT) studies to ensure product integrity and process reliability. Being responsible for the qualification and validation of facilities, equipment, utilities, areas, and HVAC systems to ensure adherence to Good Manufacturing Practices (GMP) and internal quality standards. Preparing detailed and accurate validation documentation, including protocols, reports, and compliance records to satisfy auditing and regulatory requirements. In addition to technical expertise, the role demands a proactive approach to continuous improvement initiatives and collaboration across cross-functional teams to enhance process efficiency and safety. Lupin Limited fosters an inclusive work culture that values innovation, quality, and the development of talent. This role provides an excellent opportunity to contribute to pharmaceutical quality assurance, while growing your career within a leading global organization. Work Experience Applicants should have 2 to 5 years of relevant experience in pharmaceutical cleaning validation or related quality assurance roles within a regulated environment. Experience in handling validation of facilities, equipment, and utilities in API manufacturing settings is highly desirable. Strong knowledge of cleaning validation principles, risk assessments, and regulatory expectations is essential. Education Graduation in Pharmacy Competencies Strategic Agility Innovation & Creativity Customer Centricity Developing Talent Result Orientation Process Excellence Collaboration Stakeholder Management

Location:-Dahej (Bharuch) Industry:- Agro chemical Qualification:-Bsc /Msc chemistry/ Dip chemical *Experience:- Fresher * *Post :-Plant operator * Job time:- 8 hrs shift duty Salary:- 17400 ctc Facility:- travel + canteen Job type:- Permanent Required Candidate profile Perform In-Process Quality Control (IPQC) during tablet MFG. compliance with cGMP,coordinate with QA, QC, and Maintenance.

Develop methods of analysis for new products and ensure smooth yield transfer to production. Troubleshoot technical issues in plant operations and develop reprocessing methods when required. Monitor quality and yield trends for ongoing projects.

Recruiter Details Mohaneswara Reddy https://www.linkedin.com/in/mohaneswarareddy Role & responsibilities I. Finalise unique planner and monitor its implementation for planned preventive maintenance & instrument calibrations to achieve effective maintenance and adherence to standards Supervise the PPM/Calibration planner process by giving inputs to Section Heads, collating to prepare a common Unit plan and approve the planner for the Unit Oversee adherence to PPM Schedule by periodic reviews with section heads Monitor Good Engineering Practices are followed during Planned preventive activity, and at all other times, across Unit Understand QA and User feedback on Unit maintenance procedures and improve on the same across Unit Review all Engineering Procedures for being compliant as to cGMP and GEP guidelines, and modify the non-compliant procedures II. Oversee breakdown maintenance to avoid recurrence and maintain continuous process operations by checking critical parts availability and adherence to PPM schedule Review availability of critical spares of machines as per plan to reduce resolution time Review PPM being conducted as per schedule to avoid breakdown along with Section heads by checking their schedule adherence Ensure that breakdown of machines are attended timely to minimise impact on quality and production through daily review of breakdown, scheduling work and assessing its completion. III. Seek out and recommend new vendors and technologies and recommend capability building initiatives for the Unit Engineering Team to improve the Machine performance Ensure training needs of the unit engineering team are met by assessing training needs, collecting user feedback, overseeing training calendar preparation and reviewing its implementation Recommend and arrange internal and external training/seminars to stay updated with contemporary techniques used in maintenance Recommend implementation opportunities of new technologies available in the market through external interactions and conferences IV. Implement energy savings initiatives and draft facility improvements proposals for optimum utilisation of resources to have cost effective operations Govern idea generation sessions and review participation in idea evaluation and implementation of energy savings proposals Schedule internal/external agency audits/checks to receive energy saving, improvement proposals and monitor its implementation Review and follow-up on implementation of action plans for improving deficiencies through internal/ external audits to verify GEP and GMP V. Execute, monitor and control CAPEX and OPEX across Unit to reduce cost Review cost heads within Section Heads and provide inputs to Site Engineering Head to take corrective actions for keeping cost heads under control Seek opportunities for reducing operating cost through process and utility automations, propose the same to Site Engineering Head and lead their implementation Evaluate and propose better costing options during brown field projects execution by evaluating options of alternate machinery available at lower costs Explore and implement alternate economical option during execution VI. Monitor adherence to safety /quality standards along with HSE/QA to achieve high level of Safety/quality during routine work. Check all safety interlocks of critical machines are checked as per SOP Review all safety meetings and follow-up on implementation of actions planned during departmental safety meeting across unit Ensure proper procedures for safety permits are followed through random checks and reviews with section heads Ensure compliance from government authorities during routine and new project implementation to ensure plant safety Review, approve and track of QMS tools to maintain quality matrix Plan, execute and submit to QA compliances related to regulatory audits VII. Identify scope and implement electrical, thermal, energy saving & water saving projects by evaluating its returns, saving and implementation feasibility to reduce cost and make the plant energy sustainable Monitor internal and external energy audits at the Unit Level and formulate action plans for improving on deficiencies identified Lead energy saving projects with respect to renewable energy and green fuel systems at the Unit Level Major Challenges Control on OPEX considering rate revisions and variations in product planning. Trade-off between OpEx Management and Quality of services. Difficulty in upgrading systems / equipment and implementing new ideas due to CAPEX constraints. Economical option of facility services lead to inconsistent -standard quality services. Trade-off between OpEx Management and Quality of services. Deterioration of facility with time leading to higher OpEx requirement. Seek opportunities for temporary patch-up work to increase life of facility. Lack of uniformity in Engineering documents due to absence of clear corporate guidelines. Decisions taken at Unit level after discussions. Increased workload due to Project responsibilities in addition to routine work post dissolving of core project teams. Reschedule and prioritize routing activities. Preferred candidate profile B.Tech/B.E. Mechanical engineer with 10 to 15 years of experience in API manufacturing (Maintenance and Projects). Five to seven years' experience at Section head level preferable. Technical knowledge of Pharma / machinery and utility equipment/ HVAC. Planning and execution Skills Experience in industrial automation Knowledge of GMP requirements Good leadership skills

Hiring Quality Assurance Officer with 1 to 3 year experience. Should have sound knowledge of Production of Pharma/chemical industry Documenting and keeping records and assisting QA team for in depth analysis. Handling preventive action Required Candidate profile Review of Risk Assessment & investigation report. Should be Bsc in organic chemistry. nearby western line mumbai candidates will be preferred upto Boisar,Tarapur,Palghar district. Male candidates

Title: Business Development manager Location: Hyderabad Job description You will play a pivotal role in driving business growth through your expertise in Business Development, Strategy, and Services within the Life Sciences, CRO, and Biotech industries. This position focuses on expanding our consulting and specialized services, including Regulatory Affairs, Clinical Services, Quality, Post-marketing, Labeling, and more across Europe and the USA Key Responsibilities * Lead and shape the strategic positioning of consulting and specialized services to meet the specific needs of the companies in target regions, particularly Europe and the USA. * Develop and execute robust business development strategies to achieve sales targets and drive profit growth. Cultivate and maintain strong relationships with both new and existing clients, ensuring a steady pipeline of opportunities. * Deliver impactful solution presentations to reactivated and designated target accounts, effectively demonstrating the value of our services and solutions. * Collaborate closely with marketing and pre-sales teams to drive lead generation and optimize the positioning of our services. Provide training, mentorship, and guidance to team members, fostering skill development across multiple project areas. * Take full ownership of assigned goals and targets, ensuring their successful achievement through effective strategic planning, tracking, and execution. Requirements * Bachelors Degree in Life Sciences is required, with an MBA/PGDM certification preferred. * Extensive 2-5 years) experience in business development within the Life Sciences, CRO, Biotech, or pharmaceutical industries, with a proven track record of success in regulatory and international projects.

Officer Production, Vapi, Gujarat Responsibilities: Equipment cleaning as per ECR/SOPs Ensure cGMP compliance Execute batch charging (BMR/BPR) Maintain records Complete BMR/BPR/ECR documentation Apply at talent@hireindians.com or call 8882212459. Required Candidate profile Qualifications & Skills: * B.Sc. / M.Sc. in Chemistry (Analytical/Organic/Industrial) or B. Pharma. * 1–4 years of experience in pharmaceutical formulation/API manufacturing.

Role & responsibilities To have sound Knowledge of API Production as Chemist Understanding of Reactor handling , BMR handling / BPCR Handling . Process handling, Documentation. handling the batches for distillation and monitoring in shifts as per Instruction of shift in charge. set up and adjust the machine as per batchs requirement . Preparing of Area for Audits Preferred candidate profile The candidate with API experience only Send mail with your CV attached in PDF and subject mentioning FOR POSITION OF PRODUCTION CHEMIST to jagpal.dewal@ipca.com

Candidate should have Pharma API or Chemical company background Receive, inspect, and verify raw materials, packaging materials, and other incoming goods as per SOPs. Maintain proper storage of materials following FIFO/FEFO and GMP guidelines. Ensure all materials are stored in appropriate environmental conditions (temperature, humidity, etc.). Maintain inventory records using ERP systems. Prepare and maintain GMP-compliant documentation: GRNs, stock registers, logbooks, issuance records, etc. Coordinate with Quality Control and QA for sampling and clearance of received goods. Dispense raw materials and packaging materials as per batch production requirements. Monitor and control warehouse hygiene, pest control, and housekeeping activities. Ensure compliance with safety regulations, EHS norms, and GMP requirements at all times. Participate in internal and external audits and assist in the implementation of CAPAs. Conduct periodic stock audits and cycle counts. Train and supervise warehouse helpers and staff. Preferred candidate profile Transportaion Health Insurance

As an Operator/Technician in API Manufacturing at Dewas API, your primary responsibility will be to carry out planned production activities in shift as per the production schedule. You will be required to complete various production documents such as BPR, Equipment Logbooks, Cleaning Records, Calibration records, Area monitoring records, Bounded Books, Raw material & Packing material records, Finish good records, etc. Moreover, you will be in charge of preparing the Raw material lots and packing material for Finish Goods as per SOP and perform the related documentation. It is essential to maintain the facility and associated documentation during manufacturing in accordance with cGMP/Regulatory requirements by following SOPs and established procedures. Ensuring plant maintenance as per the requirements of ISO & OHSAS and updating related documents will also be part of your duties. You must carry out plant operations with safety measures in place and attend/comply with the training assigned by the department/organization within the prescribed timeline. It is crucial to be available on your dedicated workstation, hand over the charge to another trained employee, and inform your superior before leaving the workplace. Adherence to cGMP practices, maintaining cleanliness of equipment and its surroundings, engaging in maintenance of plant & machinery, and keeping related records up-to-date are vital aspects of the role. Effective communication with superiors and subordinates is necessary to carry out work and its follow-up according to instructions. Overall, your role as an Operator/Technician in API Manufacturing will involve ensuring the smooth operation of production activities, maintaining documentation, complying with regulations, and fostering a culture of safety and efficiency within the manufacturing facility.,