236 Api Manufacturing Jobs - Page 2

Supervise and execute API production activities as per batch manufacturing records (BMR) and standard operating procedures (SOPs). Maintain all production-related documents including BMR, logbooks, deviation records, and change controls.

Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical data and escalates for resolution. Thorough knowledge and experience of drug development practice, rules, regulations, and guidelines. Demonstrates knowledge of key processes, procedures and tools. Regulatory Skills: Strong knowledge on the Regulatory requirements during both development and life-cycle management phases for US, Europe and other major markets and has expertise to oversee preparation and submission of complex regulatory submissions. Knowledge on current regulations and filings requirements for post approval. Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape. Adequate level of knowledge on general standards SOP, processes and policies of Pharma industry. Leadership Skills: Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format. Ability to comprehend and summarize complex technical data. Ability to utilize flexible approaches to negotiate skillfully in tough situations with both internal and external groups. Gains trust quickly with cross functional team to the negotiations.

Education: Degree in Chemical Engineering or a related field Experience: 15+ years in API Manufacturing Expertise: Proven leadership in large-scale manufacturing operations Key Responsibilities: Lead and manage the Technical Service Department Oversee process optimization and troubleshoot issues Ensure GMP, ICH, and regulatory compliance Provide technical support to customers and internal teams Drive continuous improvement in production efficiency, quality, and safety Mentor and grow a high-performing technical team If youre ready to take the lead in shaping the future of API production, we want to hear from you

As a Manufacturing Excellence Manager in the API unit, your key responsibility will be to monitor and control manufacturing activities to ensure the achievement of best yield and quality. You will analyze production variability, set quality benchmarks, and work towards reducing variability to enhance overall performance. Your main accountabilities will include preparing and reviewing reports on manufacturing processes to drive yield improvement, optimizing equipment capacity for increased productivity, identifying cost-saving opportunities, analyzing unit operation reports to minimize lead time, investigating rejected batches to reduce rejection levels, and exploring new technologies for cost reduction and operational efficiency. To qualify for this role, you should hold a B. E. in Chemical Engineering and have at least 10 years of experience in API Manufacturing, including 2 years in manufacturing excellence. You should possess a strong understanding of API manufacturing operations, safety standards, and cGMP systems. Key competencies and skills required for this position include collaboration, innovation, accountability, empathy in leadership, agility in decision-making, strong domain knowledge, and effective people management. This permanent position is based in Bommasandra, and the shift hours will be as per the operational requirements.,

The Team Lead Process R&D (API) will be responsible for leading a team of scientists/chemists in the development, optimization, and scale-up of robust and cost-effective synthetic processes for Active Pharmaceutical Ingredients (APIs). The role includes overseeing lab experiments, technology transfer, and ensuring regulatory compliance for process development projects. Role & responsibilities Lead a team of scientists in developing and optimizing synthetic routes for APIs from lab scale to commercial scale. Design experiments (DOE) for process improvement, cost reduction, yield improvement, and impurity profiling. Monitor and review process parameters and data generated in the lab; provide technical guidance and troubleshooting support. Ensure development of scalable, safe, and reproducible processes aligned with GMP, safety, and environmental standards. Interface with cross-functional teams including Analytical R&D, Regulatory Affairs, Production, QA/QC, and Tech Transfer. Support scale-up activities in pilot plants and commercial manufacturing sites, including batch monitoring and documentation. Prepare and review technical documents including development reports, process protocols, risk assessments, and technology transfer documents. Guide team members in literature search (SciFinder, Reaxys), route selection, and patent landscape analysis. Maintain good documentation practices and ensure compliance with internal and external regulatory standards. Key Requirements: M.Sc. or Ph.D. in Organic Chemistry / Medicinal Chemistry / Pharmaceutical Sciences. 812 years of hands-on experience in Process R&D for APIs in a reputed pharmaceutical or CRO/CDMO company. Strong background in organic synthesis, reaction mechanism, and impurity identification and control. Proven experience in scale-up and tech transfer to pilot plant or production scale. Familiarity with QbD, DOE, cGMP, ICH guidelines, and regulatory requirements (USFDA, EMA). Good communication, leadership, and project management skills.

Role & responsibilities We are pleased to announce that we are currently hiring experienced professionals for our Production & Engineering Dept., This hiring drive specifically focuses on candidates with hands-on experience in Production operations/ Documentation & HVAC/ Water systems. Water Systems/ HVAC Must have experience in Water treatment process(Eg. DM Plant, MGF, PWG, PWS, PSG & WFIG (MCDP & VC Systems) AHU and Related Equipment Maintenance works Execution. Production/ Documentation Must be having knowledge of BPR/BMR/ SOPs/ GMP Guidelines. Document preparation & review./ Clean room schedule preparation. Batch charging & must follow the GMP & Safety guidelines.

Role & responsibilities 1.Ensure proper documentation and fulfillment of statutory requirements with regards to various FDA authorities. 2. Collect information from various departments and prepare DMFs, Dossiers, amendments and supplements etc 3. Submit them to the pertinent regulatory authorities within a specified time frame to get approval. 4. Respond to queries as they arise and ensue that regishation/approvals are $anted without delay. 5. Coordinate customer and reeulatorv audits. 6. Provide compliance to customer complaints by coordination with marketing department. 7. Keep up to date of national and intemational legislations, guidelines (available on websites) and customer practices and concemed departments about the same. 8. Keep up to date with a company's product range. 9. Ensure that a company's products comply with the current regulations. 10. Formulate strategy for all regulatory submissions. 11. Participate in regulatory and customer inspections, review audit reports and submit compliance report to regulatory agency. 12. Maintain approved applications in compliance with appropriate guidance 13. Identifling the tlpe of changes & submit them as per country guidelines (life cycle management). 14. Monitor progress of all registration submissions country-wise and product-wise.

Greetings from Avani Consulting. We are hiring QC Officer / Trainee and QC Associates for a leading Pharma API Company in Mysore. Positions: 1. QC Officer / Trainee : EXP: 2 to 3 year exp in Pharma Company. Salary : Up to 4LPA ( Take way home only . NO Parks & Benefits ) 2. Quality Control Associates - API : EXP: 5 to 9 year exp in Pharma API Industry. Salary : Up to 7.5LPA ( Including Parks & Benefits ) Preferred candidate profile Qualification : M.Sc. Chemistry Experience : Pharma -API Quality Control Role & responsibilities : Handling and troubleshooting of Analytical Equipment's like HPLC, GC-HS, FT-IR, UV, Potentiometry, Polarimeter, ICP and KF. Handling of Analytical Method development and Method Validations. Qualification of Equipments as per GLP requirements. Analysis of Inprocess, Stability and FG Samples as per the Specification. Operation, Maintenance and Calibration of HPLC and GC as per the schedule. Review of results and release of Analytical test report or Certificate of Analysis. Maintenance of minimum consumables in the Laboratory. Planning and coordination to release on time results delivery. Investigation of OOT/OOS in the laboratory. Sampling of Raw Material, Inprocess and Finished product samples. Basic knowledge on LIMS/SAP. Handling 21 CFR compliance. ***NOTE :: NO CHARGES Looking forward to know about your interest. Thanks & Regards Priyanka Palit [9518220852 | priyanka@avaniconsulting.com]

LAVINA PHARMACEUTICALS PVT. LTD. SR. EXECUTIVE PURCHASE Job description A. Roles and Responsibilities With 5-6 years of experience in sourcing and procurement of pharmaceutical formulations, APIs and Packaging Materials, The position will be accountable for the entire procurement process. Sourcing Vendor development, Price negotiation and procurement. The position is based at Mumbai. Graduates with strong techno-commercial knowledge will be preferred Arranging advance payment to vendor wherever applicable, Co-ordination with logistics for vehicle arrangement for material pick-up wherever applicable, Follow-up, tracking of materials & ensure that material should reach as per given scheduled. Developing and sustaining long-term relationships with suppliers. Travelling to different places as and when required. Arranging samples as per requirement for New Product Development. Arranging DMF/COPP/COA for support to Regulatory Department. B. Desired Candidate Profile Quick learner & easily adapts well in workplace, able to work in a team and produce quality output. Punctual, reliable and must have strong verbal and oral communication skill. Self-motivated and strong analytical skills, ability to work independently. Maintain a high level of accuracy while working on the work assigned and well presented. Organize and prioritize own work, deadlines and schedules, ensuring completion within quality standards. TypeFull Time, Permanent Work Experience 5 to 6 years Role Category Procurement & Purchase Education- B.SC/ M.SC/ B. PHARMA/ M. PHARMA / MBA About Company Lavina Pharmaceuticals Pvt Ltd. Was established in the year 2004. We are the supplier and the Exporter of Pharmaceutical Formulation like Tablets, Capsules, Injectable, Creams, Infusion, and Liquids, Pharmaceuticals Intermediates, Pharmaceutical chemicals, Inorganic capsules, We are mainly involved in supplying our several range of pharmaceutical forms in East African, West Africa and Far east Countries. Lavina Pharmaceuticals Pvt Ltd covers all product range like anti-infective, anti- inflammatory and the arthritis, Cardiovascular, oncology, anti-diabetic, gastrointestinal and cough expectorant, multivitamin toxics. Company Website - www.lavinapharma.com Job responses on (email id) admin1@lavinapharma.com

Crystalline Manager Production for the distribution of the instructions and producing API’s/intermediate as per production plan.This includes responsibility for safety,cleanliness of system during product change over or after non/production activity

QA Chemist - API Pharmaceutical Industry.Responsible for monitoring & compliance of Self-Inspection and Quality Audits conducted at site.Responsible for the preparation & monitoring of HACCP & its related activity.

Essential Functions: Perform routine analysis of raw materials, intermediates, APIs, in-process samples, stability samples, and other laboratory samples as per approved specifications and methods. Carry out sampling of raw materials and packing materials in accordance with SOPs. Ensure accurate, timely, and online entry of analytical results in LIMS and relevant documentation systems. Prepare approved/rejected labels for raw materials, intermediates, and packing materials based on analysis outcomes. Conduct daily verification/calibration of analytical instruments (e.g., pH meter, balance) as per approved methods. Maintain analytical instruments in good condition and ensure logbook entries are updated regularly. Perform LIMS entries and maintain relevant analytical records for traceability and compliance. Participate in investigations related to OOS, OOT, deviations, incidents, and laboratory errors. Ensure compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and cGMP requirements in all activities. Ensure daily laboratory housekeeping and maintain laboratory safety protocols, including use of PPE. Support review and archival of analytical records and raw data as per data integrity norms. Carry out any other assignments allocated by the QC Head or Designee. Additional Responsibilities: Assist in method verification, validation, and transfer activities as required. Support review and revision of SOPs, specifications, and analytical methods. Participate in internal and external audits by providing relevant data and documents. Train junior analysts and contract staff in safe and compliant lab practices. Ensure proper retention, reconciliation, and disposal of samples as per SOPs. Support trending and analysis of analytical data (e.g., stability trends, impurity profiles). Coordinate with production and QA teams to ensure timely testing and batch release. Highlight any instrument malfunctions or quality concerns to the supervisor promptly. Qualifications :- Education: M.Sc - Chemistry / Organic Chemistry - Preferred B.Pharm / M.Pharm - Acceptable for API QC with strong analytical background Experience: 3 to 6 years of relevant experience in Quality Control - exclusively in API manufacturing environment Skills: Analysis of API, RM, Intermediate Samples - Intermediate to Advanced Instrumental Analysis (HPLC, GC, UV, KF, IR, etc.) - Intermediate LIMS Operation and Data Entry - Intermediate Handling and Review of Analytical Documentation - Intermediate OOS/OOT/Deviation Investigation Participation - Intermediate Good Laboratory Practices (GLP) - Advanced Good Documentation Practices (GDP) - Advanced Laboratory Safety and Compliance - Intermediate Data Integrity Principles - Advanced cGMP Awareness Specific to API Environment - Advanced.

Essential Functions: Perform routine analysis of raw materials, intermediates, APIs, in-process samples, stability samples, and other laboratory samples as per approved specifications and methods. Carry out sampling of raw materials and packing materials in accordance with SOPs. Ensure accurate, timely, and online entry of analytical results in LIMS and relevant documentation systems. Prepare approved/rejected labels for raw materials, intermediates, and packing materials based on analysis outcomes. Conduct daily verification/calibration of analytical instruments (e.g., pH meter, balance) as per approved methods. Maintain analytical instruments in good condition and ensure logbook entries are updated regularly. Perform LIMS entries and maintain relevant analytical records for traceability and compliance. Participate in investigations related to OOS, OOT, deviations, incidents, and laboratory errors. Ensure compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and cGMP requirements in all activities. Ensure daily laboratory housekeeping and maintain laboratory safety protocols, including use of PPE. Support review and archival of analytical records and raw data as per data integrity norms. Carry out any other assignments allocated by the QC Head or Designee. Additional Responsibilities: Assist in method verification, validation, and transfer activities as required. Support review and revision of SOPs, specifications, and analytical methods. Participate in internal and external audits by providing relevant data and documents. Train junior analysts and contract staff in safe and compliant lab practices. Ensure proper retention, reconciliation, and disposal of samples as per SOPs. Support trending and analysis of analytical data (e.g., stability trends, impurity profiles). Coordinate with production and QA teams to ensure timely testing and batch release. Highlight any instrument malfunctions or quality concerns to the supervisor promptly. Qualifications :- Education: M.Sc - Chemistry / Organic Chemistry - Preferred B.Pharm / M.Pharm - Acceptable for API QC with strong analytical background Experience: 4 to 8 years of relevant experience in Quality Control - exclusively in API manufacturing environment Skills: Analysis of API, RM, Intermediate Samples - Intermediate to Advanced Instrumental Analysis (HPLC, GC, UV, KF, IR, etc.) - Intermediate LIMS Operation and Data Entry - Intermediate Handling and Review of Analytical Documentation - Intermediate OOS/OOT/Deviation Investigation Participation - Intermediate Good Laboratory Practices (GLP) - Advanced Good Documentation Practices (GDP) - Advanced Laboratory Safety and Compliance - Intermediate Data Integrity Principles - Advanced cGMP Awareness Specific to API Environment - Advanced.

Hi, Greetings Walk in Invitation: We are having face to face interview on 19th July 2025 Saturday in Mysore Single Round Face to face Company : A leading Pharma API Unit - in Mysore Position - Production Department Associate Work Experience Min 3 yrs in API in current Hike would be appreciable on Current CTC Note: No Charges If interested drop your CV to Priyanka Palit [ 7780363938|| jyotsna@avaniconsulting.com ] Thanks & Regards Priyanka Palit

Hi, Greetings Walk in Invitation: We are having face to face interview on 19th July 2025 Saturday in Mysore Single Round Face to face Company : A leading Pharma API Unit - in Mysore Position - Production Department Associate Work Experience Min 3 yrs in API in current Salary 20% to 25 % hike on current CTC. Note: No Charges If interested drop your CV to Priyanka Palit [ 9518220852 || priyanka@avaniconsulting.com ] Thanks & Regards Priyanka Palit

Responsibilities: * Manage raw material procurement for chemicals & specialty chemicals * Ensure timely delivery of APIs & intermediates * Optimize supplier relationships through negotiation & cost reduction strategies Provident fund

Technical Skill : Routine Operation & Analysis API Products HPLC, WET Lab Analysis

1.Routine Operation & Analysis API Products 2.HPLC, WET Lab Analysis

We are seeking a dedicated & skilled Production Officer to join our team. The ideal candidate should have experience in a regulatory-approved manufacturing plant with experience in handling critical production equipment & knowledge of cGMP standards.

1. Experience in electrical maintenance, substation operations, & power distribution transformers, and H.T & L.T panels 2. Proficiency in preventive, predictive, and corrective maintenance ensures system reliability & minimal downtime Required Candidate profile 3. Experience with HVAC, compressed air systems 4. Knowledge of GMP, regulatory compliance, and statutory requirements supports adherence to industry standards.

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

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 Title: Production Head Dahej Department: Production API Manufacturing Location: Dahej Plant, Gujarat Company: Cadila Pharmaceuticals Ltd Job Purpose: To lead and oversee all API manufacturing operations at the Dahej plant, ensuring compliance with cGMP, safety, quality, productivity, and cost-effectiveness, while maintaining a culture of continuous improvement. Key Responsibilities: 1. Production Management Plan, coordinate and execute API manufacturing activities in line with production schedules and business targets. Ensure optimum utilization of plant capacity, manpower, and resources. Monitor key production KPIs and take corrective/preventive actions as necessary. 2. Compliance & Quality Ensure strict compliance with cGMP, ICH, regulatory guidelines, and internal quality standards. Coordinate with QA/QC, Regulatory Affairs, and EHS departments to maintain inspection readiness (USFDA, WHO, EDQM, etc.). Support quality investigations (deviations, OOS, change control, CAPA) related to production activities. 3. Safety & Environment Drive a strong safety culture by ensuring adherence to all EHS standards. Lead risk assessments (HAZOP, JSA) and support implementation of safety recommendations. 4. Team Management Lead, develop and mentor a team of production professionals, operators, and shift in-charges. Promote cross-functional collaboration, performance management, and employee engagement. 5. Process Optimization & Projects Initiate and implement process improvement initiatives (Lean, Six Sigma, OEE improvement). Collaborate with Engineering, Projects, and Technology Transfer teams for new product introductions and capacity expansions. 6. Documentation Ensure timely and accurate documentation of batch records, logbooks, equipment cleaning records, and SAP entries as per GMP requirements. Desired Candidate Profile: Qualifications: B.E./B.Tech in Chemical Engineering or M.Sc. in Chemistry Additional certifications in GMP/Lean/Six Sigma will be an added advantage Experience: 12–20 years of experience in API Manufacturing At least 3–5 years in a leadership role handling large-scale production units Hands-on experience with regulatory audits (USFDA, EU, etc.) Skills & Competencies: Strong technical knowledge of API manufacturing processes (solvents, reactors, crystallization, etc.) Proven leadership and people management capabilities Good understanding of GMP, EHS, and SAP systems Strong analytical, communication, and decision-making skills Interested candidate can share there cv at shardulsinh.k@cadilapharma.com

1. Experience in API / Intermediates manufacturing company 2. Working as per SOP and follow the safety protocols 3. Working experience in GMP environment 4. Maintaining Documentation / BMR

Supervising Production Teams & Production Planning Monitoring and controlling production parameters Ensuring GMP Compliance Collaborating with other departments Operating, cleaning, and maintaining manufacturing equipment & Documents BMR