236 Api Manufacturing Jobs - Page 8

Roles and Responsibilities Ensure compliance with cGMP guidelines by maintaining accurate records of production activities. Collaborate with cross-functional teams to resolve issues related to product quality and process optimization. Participate in continuous improvement initiatives to enhance efficiency and reduce costs. Conduct quality analysis of raw materials, intermediates, and finished products using various analytical instruments such as HPLC, GC, UV Spectrophotometer, etc. Prepare and review BMRs (Batch Manufacturing Records) for API manufacturing processes. Desired Candidate Profile 0-2 years of experience in API Manufacturing or Quality Control department. Diploma holder in Chemical or Pharmaceutical field from a recognized institution. Strong understanding of SCADA systems and ability to operate PLC programming software.

Position Overview: We are looking for a Sr. Manager will be responsible for leading and managing end-to-end multiple API production blocks. The role requires ensuring optimal productivity, quality, cost control and regulatory compliance in alignment with cGMP standards. This position plays a critical role in driving continuous improvement, cross-functional coordination, and operational excellence within the production unit.. Key Responsibilities: Oversee daily production activities to ensure efficiency, quality, and cost-effective management of resources. Develop and implement production schedules based on inventory / market requirements / capacity constraints and provide feedback accordingly. Deployment of manpower & supervisor as per production requirement. Monitor and adjust production processes as necessary to meet production targets and quality standards. Ensure all production batch records are completed and signed off on time. Responsible or keeping production facilities clean and appropriately disinfected. Responsible for the validation protocols and reports are completed and signed. Responsible for qualification of new and modied facilities, when appropriate and equipment. Responsible for maintaining and updating the documents related to the Production activities. Ensure smooth production under EHS & cGMP compliance. Ensure for reporting of all production deviations and evaluation of the same. Ensure process problems /deviations are solved and rectified within a set of time frame, co-ordination/follow up with all the departments like R&D, MSTG, QC, QA, Engineering & Stores. Institute operational controls, monitor the key characteristics, carry out root cause analysis for the non-conformity and take CAPA. Responsible for self-inspection of the area w.r.t EHS and production systems. Responsible for training all the employees of production. Responsible for preventive maintenance is executed as per the planned schedule. Responsible for analyzing the time cycle of each batch and taking corrective actions if any deviations are observed. Responsible for any optimization initiative across the production blocks. Ensure that the yield, % solvent recovery and quality of APIs and Intermediate products are as per the standard norms. Analyze production costs and recommend strategies to reduce costs and improve Profitability. Responsible for monthly RM requirement and weekly RM schedule. Responsible for performing of Internal audit. Responsible for water consumption, effluent generation as per the set norms. Responsible for controlling hazardous waste generation. Identification of Risks & Hazards, Environmental aspects & evaluation and review the same. Responsible for any other work assigned by senior management in the absence of Site Head/ Unit Head. Qualifications and Experience: Analytical Skills and Communication Basic understanding of pharmaceutical or chemical industry Strong organizational, multitasking abilities, time management skills Company Website :- www.scllifesciences.com

Role & responsibilities You will be working as Manager Mechanical Engineer for their Pharma (API) plant based at Patalganga. 1.Candidate will be responsible for overseeing the efficient execution of API production activities in line with GMP and safety standards. 2. You will be responsible for Maintenance of process machinery, Designing, scheduling, implementation and documentation of preventive maintenance 3. You will be responsible for Installation and started machine plant, with all utility equipment. 4. You will be responsible for machines preventive and predictive maintenance. 5. You will be coordinate with the Purchase Department for spares related to projects and maintenance 6. You will be good in team management and monitoring team. 7. You will be participating in Regulatory audits, internal audits within and cross functional Department. 8. You will be ensure review and effectiveness verification of QMS activities (Deviation / investigation / change control & CAPA) 9.Candidate will be responsible for Supervision of R&D party contractors and internal service providers and ensuring all work carried out is completed in accordance with Standards. 10. Candidate have to ensure compliance with customer and statutory audits from the engineering department Preferred candidate profile 1. Candidate should be B.E /B.Tech Mechanical Engineering and 15 Years of experience in Pharma Industry 2. Candidate should have experience in Support function for Project Execution and Project Co-Ordination for Pharma (API) timely completion of projects support and drive Installation, commissioning, Validation/Qualification activities. 3. Candidate should have experience in preparing calibration schedule, preparing training schedule and facing internal & external Audits and giving compliance. 4. Candidate should have experience in handling overall maintenance activities for Plant Equipment and Utilities. 5. Should have thorough knowledge of cGMP, building maintenance activities, as per US and other regulatory requirement related to Electrical Engineering / Maintenance department.

Roles and Responsibilities Collaborate with cross-functional teams to resolve issues related to product development, manufacturing processes, and regulatory compliance. Ensure adherence to cGMP guidelines and company policies throughout all aspects of production chemistry operations.

Preventive Breakdown Maintenance, Plant Regular Maintenance & Plant Utility Maintenance Coordination with Vendors for Repairs and Maintenance, Equipment finalization.

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

Job Responsibilities are not limited: Overall responsibility of raw material, finished goods & engineering stores. To ensure the receipt and proper storage of material. The safe practices in Stores. Must have the knowledge of MSDS & other EHS. Required Candidate profile Knowledge of NDPS Act, GST and Excise is must. Develop the talent of self & team in the WH related activities primarily. To maintain practices, records & systems as per cGMP.

Job Overview To perform quality control testing of raw materials, intermediates, and finished products as per approved specifications, ensuring compliance with cGMP, regulatory, and company standards. Roles and Responsibilities: Conduct chemical and instrumental analysis of raw materials, intermediates, and peptide APIs using HPLC, GC, UV-Vis, IR, Karl Fischer, and TOC. Execute peptide-specific analytical techniques including reverse-phase and ion-exchange HPLC, amino acid analysis, and peptide mapping where applicable. Perform method validation, verification, and transfer in line with ICH guidelines. Maintain and review analytical documentation such as SOPs, STPs, specifications, and validation protocols. Ensure compliance with cGMP, GLP, and data integrity practices in all laboratory operations. Support OOS/OOT investigations, perform root cause analysis, and assist in CAPA implementation. Monitor calibration, maintenance, and qualification of analytical instruments as per the approved schedule. Prepare samples and documents for regulatory submissions and audits (e.g., DMF support, ANDA filings). Coordinate with QA, RA, Production, and RD for timely resolution of issues and release of batches. Participate actively in regulatory audits (USFDA, EUGMP, WHO, etc.) and internal quality audits. Experience 1-4 years of experience in QC in pharmaceutical / chemical / API manufacturing industry Competencies Hands-on experience with instruments like HPLC, GC, UV-Vis, and others. Sound understanding of cGMP, GLP, and regulatory guidelines Strong documentation and communication skills. Ability to work in shifts and under pressure. Team player with problem-solving and analytical skills. 2-5 years of experience in the QC department of a USFDA / EUGMP-approved peptide/API manufacturing company

Role & responsibilities JD Of Officer production : Having exposure in batch process handling in API manufacturing. Hydrogenation block work experience OR shift in charge role will be an added advantage. Recording QMS documents as per cGMP guidelines Having knowledge on safety measures in batch operations execution. Following shift operation as per the production plan with safe and cGMP environment and responsible for maintaining good housekeeping of plants Shall submit the in process / intermediate sample to QC lab for analysis as per the batch instruction. JD Of Jr.officer production : To receive operating instructions for the shift from Production Executive. 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 candidates with good exposure in API Manufacturing industry .(Only Male candidates can attend interview ).

Roles and Responsibilities Conduct HAZOP, HIRA, HAZID studies to identify potential hazards in processes. Develop and implement process safety management systems (PSMS) for API manufacturing and bulk drug production. Ensure compliance with regulatory requirements related to environment health & safety (EHS). Collaborate with cross-functional teams to design new products and processes that meet industry standards. Provide training on EHS procedures and best practices to employees. Desired Candidate Profile 4-7 years of experience in Process Safety Management System (PSMS), HAZOP/Hazid/Hira/LOTO etc. Diploma or B.Sc degree in Any Specialization; relevant certifications like NEBOSH IGC would be an added advantage. Strong understanding of pharmaceutical regulations such as GMPs, OSDs, Injectables etc.

Roles and Responsibilities Conduct quality control analysis of bulk drugs, APIs, and pharmaceutical products using techniques such as HPLC, GC, and method validation. Perform stability studies to ensure compliance with GMP guidelines. Calibrate instruments accurately and maintain records of instrument maintenance schedules. Ensure accurate documentation of test results, reports, and certificates of analysis. Collaborate with cross-functional teams to resolve quality issues. Only male candidates

Roles and Responsibilities Conduct quality control activities such as BMR reviews, stability studies, process validation, and equipment qualification. Ensure compliance with cGMP guidelines and regulatory requirements through IPQA activities. Investigate deviations and CAPAs to maintain product quality and prevent recurrence of issues. Collaborate with cross-functional teams for change control processes and batch manufacturing record (BMR) review. Perform analytical testing using HPLC/GC/UV methods to ensure product purity. Desired Candidate Profile 2-7 years of experience in API manufacturing or bulk drug industry only male candidate. MS/M.Sc(Science) degree in Chemistry or related field; . Strong understanding of Good Manufacturing Practices (cGMP), Current Good Laboratory Practice (cGLP), and International Organization for Standardization (ISO). Proficiency in handling chemicals safely according to OSHA regulations.

Job Overview To perform quality control testing of raw materials, intermediates, and finished products as per approved specifications, ensuring compliance with cGMP, regulatory, and company standards. Roles and Responsibilities: Conduct chemical and instrumental analysis of raw materials, intermediates, and peptide APIs using HPLC, GC, UV-Vis, IR, Karl Fischer, and TOC. Execute peptide-specific analytical techniques including reverse-phase and ion-exchange HPLC, amino acid analysis, and peptide mapping where applicable. Perform method validation, verification, and transfer in line with ICH guidelines. Maintain and review analytical documentation such as SOPs, STPs, specifications, and validation protocols. Ensure compliance with cGMP, GLP, and data integrity practices in all laboratory operations. Support OOS/OOT investigations, perform root cause analysis, and assist in CAPA implementation. Monitor calibration, maintenance, and qualification of analytical instruments as per the approved schedule. Prepare samples and documents for regulatory submissions and audits (e. g. , DMF support, ANDA filings). Coordinate with QA, RA, Production, and RD for timely resolution of issues and release of batches. Participate actively in regulatory audits (USFDA, EUGMP, WHO, etc. ) and internal quality audits. Experience 1-4 years of experience in QC in pharmaceutical / chemical / API manufacturing industry Competencies Hands-on experience with instruments like HPLC, GC, UV-Vis, and others. Sound understanding of cGMP, GLP, and regulatory guidelines Strong documentation and communication skills. Ability to work in shifts and under pressure. Team player with problem-solving and analytical skills. 2-5 years of experience in the QC department of a USFDA / EUGMP-approved peptide/API manufacturing company

Roles And Responsibility : Senior Research Chemist in the Process Research Department at Dr. Reddys Institute of Life Sciences, Hyderabad. Develop and execute laboratory experiments to successfully complete customer projects. Conducting feasibility studies, optimizing, and scaling up reactions for the synthesis of APIs, intermediates, and key starting materials. Ensure compliance with regulatory requirement and industry standards. Provide necessary support to plants for product trials, scale up, pilot batches. Provide technical support to tech transfer process and documentation. Continuous process improvement of API Collaborate with cross functional teams, Quality assurance, vendors, sum Ensuring a well-organized and safe laboratory environment while motivating others to uphold the same standards. Employ HPLC, GC, Mass spectrometry and NMR techniques to interpret and characterize product profiles. Perform feasibility studies, risk assessments, and process evaluations to foster continuous improvement and drive innovation. Extensive experience in a wide variety of chemical and dry reactions.

Industry Preference (Mandatory) Applicants must have prior work experience in at least one of the following regulated manufacturing sectors: Sterile/Injectables Manufacturing Medical Devices Manufacturing Medicinal Equipment Manufacturing Position Overview We are looking for a proactive and detail-driven Quality Control (QC) Engineer with 35 years of experience in Sterile/Injectables , Medical Devices , or Medicinal Equipment manufacturing environments. This role is critical to ensuring consistent product quality through comprehensive analytical testing and adherence to stringent regulatory standards. The ideal candidate will have hands-on expertise in chemical analysis, pharmacopeial testing, and GMP-compliant documentation, especially within a sterile or cleanroom environment. Key Responsibilities Conduct routine testing of raw materials, in-process samples, and finished products in accordance with pharmacopeial guidelines (IP/BP/USP/Ph. Eur.). Perform detailed Pharma Copea Testing including identification, assay, dissolution, impurity profiling, and other analytical parameters. Execute general wet chemistry procedures along with pH and conductivity testing . Operate and calibrate analytical instruments including IR Spectroscopy , STIR , and related chemical analysis equipment. Ensure strict compliance with Good Manufacturing Practices (GMP) , Good Laboratory Practices (GLP) , and internal Standard Operating Procedures (SOPs) . Maintain complete and accurate documentation including test reports, calibration records, instrument logs, and change control records. Support investigations related to Out of Specification (OOS) and Out of Trend (OOT) results, including root cause analysis and CAPA. Liaise with Quality Assurance (QA) , Production , and R&D teams for resolution of analytical issues and technical support. Prepare for and participate in internal and external audits, ensuring full laboratory compliance and readiness. Manage sample collection, labeling, storage, and contribute to stability studies where applicable. Candidate Requirements Educational Qualification (Preferred): B.Sc / M.Sc in Chemistry B.Pharm / M.Pharm with a focus on Pharmaceutical Chemistry Experience: 3–5 years of relevant experience in a pharmaceutical or regulated manufacturing environment Must have worked in Sterile , Injectables , Medical Devices , or Medical Equipment manufacturing Technical Skills: In-depth knowledge of pharmacopeial testing methods and documentation practices Hands-on experience with IR Spectroscopy, STIR, pH meters, and conductivity meters Familiarity with analytical method validation and instrument calibration Strong understanding of Data Integrity , GDP (Good Documentation Practices) , and compliance in regulated cleanroom settings

Roles and Responsibilities Fly drones over an agricultural field for crop spraying Analyze and plan the pre-flight Maintain the drones periodically Calibrate the sensors and sprayers whenever required Coordinate with farmers, marketing team, and field assistants Generate the work reports on a daily basis Education Qualification Any Degree Having a Remote Pilot Certificate (Small/Medium) is a plus Job Type: Full Time Job Location: Karnataka Vacancies: 5 Qualification: Any Degree with DGCA certified RPI Experience: 1 to 2 Years

Role & responsibilities In process / Intermediate / Raw Material test limits preparation as per MPR • Receive and safeguard Batch Production Record (BPR) from QA • Follow the appropriate Good Manufacturing Practices • Ensure that entire operations are being carried out in a prescribed manner • Handle the Non-Confirming product as per the Shift-In charge • Follow the transfers of intermediates/ Final Product/ finished product to appropriate storage area • Record any deviation or abnormality in the batch production records during the process and inform the same to Shift-In charge • Prepare the deviation report for standard time deviations and deviation of BPR operations during the process • Responsible for calibration of equipment and cleaning activities • Participate in performance qualification of the equipment • Responsible for checking the intermediate analytical reports status during the process • Responsible for filling the reduce/skip testing format • Check yield calculations in CPR • Prepare protocol request from and fill the data in protocol forms • Involved in storage tanks periodical inspections • Prepare the Finished product transfer note Preferred candidate profile 1-3 years experience in API Manufacturing

Role and Responsibility: Equipment mapping for Pre-validation / Validation batches. Prepare of Process Flow Diagram for pre-validation and validation batches. Execute the activities related to the Technology Transfer. Review the optimized process and provide suggestions for feasibility towards plant scale. Review the Lab/Kilo/Pilot data and understand the yield and quality trend. Active the same at plant batches considering the best as a benchmark. Preparation of volume calculation and Technology Transfer protocol for the product as per SOP. Preparation of Pre-validation batch report as per SOP and Technology Transfer report for validation batches as per SOP. Batch size determination, Utility calculation, Debottlenecking, Process optimization, Tro shooting. Handling change control initiation in Track wise & closing of scale up & validation batches.

Roles and Responsibility: Scale up chemical processes from laboratory (R&D) to pilot and commercial production levels. Collaborate with cross-functional teams (R&D, production, QA/QC, EHS) to support end-to-end process development. Perform process simulations, material and energy balances, and necessary calculations for scale-up. Identify and implement process improvements to increase yield and reduce costs. Conduct lab experiments and gather data to support scale-up strategies. Transfer developed processes to plant level and provide hands-on support during initial batches. Prepare comprehensive technology transfer documents and ensure smooth handover to plant teams. Evaluate alternative technologies and recommend process optimization strategies. Support cost reduction initiatives without compromising quality or safety. Monitor batch-wise performance and troubleshoot deviations during commercial production. Preferred Candidate Profile: 10 to 15 years of experience in process engineering, technology transfer, or production support in chemical/pharma/API industries. Strong knowledge of chemical unit operations, scale-up techniques, and process safety. Hands-on experience in preparing process documents like PFDs, material & energy balances. Familiar with regulatory and GMP requirements (for pharma roles). Excellent analytical, communication, and cross-functional collaboration skills. Ready to work at plant locations during initial batch production if needed.

Industry:- Pharma / Chemical /ETP Location :-Surat / Vadodara/ Navsari /Bharuch Qualification :-Bsc/M.sc Chemistry Experience :- 2-5 year Post :- Production QA/RA/QC Chemist Salary :20 k to 40 k CTC Male / Female Required Job Time : 9 am to 6 pm Required Candidate profile Perform In-Process Quality Control (IPQC) during tablet MFG. compliance with cGMP,coordinate with QA, QC, and Maintenance. +91 90816 99400 / +91 90816 99600 /+91 90816 99500

Quality professional with 1 5 .0 + years of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement & API Manufacturing, QMS, Qualification, Validation and other Manufacturing functions. Personnel shall have experience to handle certification, customer & regulatory inspection i.e.: IMS, WHO-GMP, FSSC, FAMI-QS, EnMS , Halal, Kosher & Responsible Care & regulatory (FDCA, USFDA, MHRA). Expertise in change control, deviation, market complaint, non-conformance investigation, vendor audit, self-inspection, gap assessment, customer audit, training, vendor management, vendor questionnaire, validation, equipment & utility system qualification & digitization Def The Person Qualifications & Experience: - M.Sc - Chemistry 15+ years of exp. Industry experience Personal Characteristics: - Ability to work in a matrix organization. An excellent people manager and leader; able to recruit, develop and retain a high calibre team across diverse departments. Able to work effectively within a global business culture whilst also adaptable to the local cultural environment. Ability to energise his/her team with a clear vision of the business Excellent communication and negotiation skills Should have an entrepreneurial mind-set Strong negotiation and analytical skills

The Position Organization : - Jubilant Ingrevia Limited Designation / Position: - Dy Manager QA Band / Grade / Level: - L2 Location : - Bharuch Job Summary (Optional): - Reporting Manager: - Sr. Manager -QA Direct Reports (Optional): - Nil Team Size (Optional): - 10 Matrix Relationship (Optional): - Key Responsibilities Quality professional with 15.0+ years of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement & API Manufacturing, QMS, Qualification, Validation and other Manufacturing functions. Personnel shall have experience to handle certification, customer & regulatory inspection i.e.: IMS, WHO-GMP, FSSC, FAMI-QS, EnMS, Halal, Kosher & Responsible Care & regulatory (FDCA, USFDA, MHRA). Expertise in change control, deviation, market complaint, non-conformance investigation, vendor audit, self-inspection, gap assessment, customer audit, training, vendor management, vendor questionnaire, validation, equipment & utility system qualification & digitizationDef The Person Qualifications & Experience: - M.Sc- Chemistry 15+ years of exp. Industry experience Personal Characteristics: - Ability to work in a matrix organization. An excellent people manager and leader; able to recruit, develop and retain a high calibre team across diverse departments. Able to work effectively within a global business culture whilst also adaptable to the local cultural environment. Ability to energise his/her team with a clear vision of the business Excellent communication and negotiation skills Should have an entrepreneurial mind-set Strong negotiation and analytical skills

Dear Candidate, Designation: Sales /Business Development - API & Pharma Location - Baddi HP Company - KP Manish Global Ingredients Pvt. Ltd. JOB DESCRIPTION Overview: The Manager - Business Development involves in sales & marketing activities, coordinating with the Application Lab, providing technical support, managing queries, and fostering strong customer relationships to achieve revenue targets. As a B2B-focused role, the Manager - Business Development collaborates closely with the zonal level to bridge the gap between technical details and commercial value, ensuring the successful execution of sales initiatives. Responsibilities: 1. Sales: Actively engage in sales activities to acquire new customers, expand market share, and achieve revenue targets within designated territories. 2. Customer Relationship Management: Build and maintain relationships with existing and potential customers, understanding their needs, preferences, and challenges to tailor solutions effectively. 3. Technical Support: Provide technical assistance and guidance to customers, leveraging expertise in ingredient applications and functionalities to address technical queries and provide value-added solutions. 4. Application Development Coordination: Collaborate with the Application Lab to coordinate customer-related application development projects, ensuring alignment with customer requirements and timely delivery of solutions. 5. Market Analysis: Conduct market research and analysis to identify opportunities, competitive dynamics, and emerging trends, providing insights to inform business development strategies and sales approaches. 6. Query Management: Manage customer inquiries, concerns, and requests promptly and effectively, ensuring high levels of customer satisfaction and retention. 7. Collaboration with Zonal Techno-Commercial Manager: Work closely with the Techno-Commercial Manager at the zonal level to align technical details with commercial objectives, ensuring that product knowledge translates into commercial success in sales efforts. 8. Performance Reporting: Prepare regular reports on sales activities, pipeline status, customer interactions, and market trends, providing insights and recommendations to optimize business development efforts and achieve sales targets. Qualifications: Bachelors degree in business administration, Marketing, or related field. Technical background or relevant experience in the ingredient trading industry preferred. Proven track record of successful sales experience, preferably in a B2B environment, demonstrating the ability to meet or exceed sales targets. Strong understanding of technical aspects related to ingredient applications and functionalities, with the ability to communicate technical information effectively to customers. Excellent negotiation, communication, and interpersonal skills, with a customer-centric approach. Ability to work independently and collaboratively within a team, with a focus on driving results and achieving business objectives. Analytical mindset with the ability to interpret market data, customer insights, and sales metrics to inform strategic decision-making

Role & responsibilities Responsible for all process operation / activities during the shift as per CGMP. To maintain BMR/BPR/BCR etc. for record the batches. To co-ordinate with engineering department for the shift break down jobs. To handle manpower during the shift as per process operations. To work in safe work environment and ensure the sub ordinate are working in safe To maintain good housekeeping in respective area. To co-ordinate for the raw material from warehouse for issuing the raw materials. To co-ordinate to QC dept. for In- process and Intermediate testing. To fill the entire document legible. To record and maintain all the documents online as per CGMP.. Preferred candidate profile Education : B.sc Chemistry Suitable Candidates please share the cvs below mail id Ramesh.sanaboni@amneal.com 9550545943

New Client Acquisition & Business Development: • Minimum 3+ years of proven experience in sales and business development within the Pharmaceutical raw materials Domestic B2B API , Excipients sales Reach me@ 8687773611 Required Candidate profile • Strong network within pharmaceutical companies in Hyderabad, Bangalore, Chennai & Pondicherry is a plus! • Experience with pharma raw material distributors/manufacturers is preferred