236 Api Manufacturing Jobs - Page 7

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

Job Description: We are looking for a dynamic and experienced Production Officer to oversee day-to-day production activities in our API manufacturing plant . The ideal candidate should have a strong understanding of batch processing, GMP compliance, equipment operation , and regulatory documentation . Key Roles & Responsibilities: Execute production activities as per batch manufacturing record (BMR) and standard operating procedures (SOPs) . Handle and operate plant equipment such as reactors, centrifuges, ANFD, FBD, dryers , etc. Ensure timely charging and discharging of materials and maintain strict compliance with process parameters . Perform in-process checks and report any deviation or abnormalities. Maintain online documentation including logbooks, equipment usage records, cleaning records, and BMR entries. Monitor critical process parameters and ensure compliance with cGMP , safety , and EHS standards . Coordinate with QA/QC for line clearance, sampling, and process validations . Ensure cleaning and sanitization of production areas and equipment as per defined protocols. Support in process validation, scale-up batches, and technology transfer when required. Follow all safety protocols , including proper usage of PPE and handling of hazardous chemicals. Report incidents, deviations, and OOS/OOT results to the production supervisor or department head. Ensure timely completion of production targets with quality and compliance focus.

hi WE ARE HRINING EXPERIENCE ;- 8 to 10 YEARS CTC;- 7LPA LOCATION;- RAIKOT (Ludhiana) Industry ;-API PLANT

Synnat Pharma Pvt Ltd seeks a proactive Maintenance Executive to ensure equipment reliability and minimize downtime at our Visakhapatnam API manufacturing facility. You will execute preventive maintenance, troubleshoot malfunctions, manage spare parts, and collaborate on corrective actions. Responsibilities include overseeing civil/fabrication activities, adhering to SOPs, and maintaining documentation. Strong technical problem-solving skills and a commitment to quality/safety are essential. Job Details: Industry: API Manufacturing Department: Maintenance Role: Maintenance Executive Location: Visakhapatnam Compensation: 2-4 LPA Experience: 1-3 years Qualification: Bachelor's Degree in Mechanical Engineering, Electrical Engineering, or a related field Responsibilities: Develop and implement preventive maintenance schedules (PPM) for process and critical equipment, adhering to industry best practices and Synnat Pharma's SOPs. Conduct equipment inspections and performance monitoring to proactively identify and address potential issues. Analyze maintenance data to identify trends, predict equipment failures, and optimize PPM schedules. Respond to equipment breakdowns, troubleshoot issues, and perform necessary repairs on mechanical, electrical, and instrumentation systems. Manage spare parts inventory, ensuring critical items are readily available for timely repairs. Oversee basic civil and fabrication activities related to facility and equipment maintenance. Maintain accurate maintenance documentation, including manuals, SOPs, schedules, and repair records. Ensure all maintenance activities comply with regulatory requirements (FDA, cGMP). Implement corrective actions to prevent recurrence of equipment failures and improve reliability. Collaborate with production to schedule maintenance, minimizing disruption and maximizing uptime. General Expectations and Past Experiences: 1-3 years' Maintenance Executive experience in API Manufacturing (Preventive Maintenance, Troubleshooting). Hands-on experience: Civil/Fabrication, Mechanical/Electrical Systems Repair (Pharmaceutical). Solid understanding of API Manufacturing, Equipment Validation, and SOPs. Proven ability to develop Maintenance Schedules, reduce Downtime, and execute Corrective Actions. Familiarity with Procurement, Spare Parts, and Maintenance Documentation. Excellent Teamwork & Communication skills. Proficient in Maintenance Risk Assessment and Best Practices.

Business: PPL Digwal Department: PTS Job Overview: To perform Production actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - R&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety External: NA Experience: 4--8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Design the scheme of experiments. 2. Plant trouble shooting, investigation and root cause analysis. 3. IUT support for vendor qualification and plant batches. 4. Carry out experiments during the feasibility and optimization stage. 5. Visualize the development needs of the product. 6. Understand the safety and environmental aspect. 7. Solve the problems and queries related to the development of the product and discuss them with the Group Leader / HOD. 8. Familiarize with the problems faced during scale-up and identifying all critical process parameters for a seamless scale-up 9. Knowledge on IUT, VQ, LFR/PDR reports documentation. 10. Understand the scalability of the chosen process, in coordination with TSD and Production. 11. Amicable relationship with PRD and ARD and work planning accordingly 12. Keep the Group Leader well informed about the experiments and their results by maintaining the lab journal/ documents well. 13. Technology Transfer for new project to Production plant. 14. Document project progress regularly with all relevant information. 15. Document all the relevant data in systematic manner and regularly discuss with group leader for way forward. 16. Required literature survey knowledge on project progress timely and discuss with group leader. 17. Mentor and guide the junior chemists in the lab on process development. Responsible for his/her training needs and appraisal along with the Group leader. 18. Keep the work area clean and the laboratory auditable all the time. 19. Responsible for department related administrative activities identified by the group leader/HOD from time to time. 20. Flexible for working on project requirement. 21. Voluntarily involve in additional responsibilities., Safety related, ESI, and corporate social responsible programs based on requirement 22. Ready, responsible and accountable for changes as per internal and customer requirements for successful execution of project on time as and when required. Qualifications Qualification : M.Sc (Chemistry) & (Organic Chemistry)

Role & responsibilities - Dossier preparation, review and submission in ACTD/CTD/ Country specific formate and also in ROW. - Review of technical documents - Responding to dossier - related queries. - License related activity. - Strong coordination with functional related department. Preferred candidate profile Dossier Preparation, Submission, Technical Review

Role & responsibilities Market Analysis and Strategy Development: Conduct thorough market research to identify products, trends, opportunities, and competitive landscape in the API trading sector. Develop and implement trading strategies online and offline to maximize presence and profitability in export markets. Experience in managing multiple projects simultaneously, ensuring timely delivery and quality. Client Relationship Management: Build and maintain strong relationships with key clients and stakeholders in domestic and exports markets. Act as the primary point of contact for clients, addressing inquiries and resolving issues promptly. Sales and Revenue Generation: Drive marketing initiatives to achieve revenue targets and expand market share in export markets independently. Sourcing & Supply Chain Management: Independently develop new sources for products and coordinate and negotiate with suppliers & manufacturers wherever needed. Coordinate with exports , operations team and logistics partners to ensure timely execution of client orders. Regulatory Compliance: Stay updated on changes in regulations and industry standards affecting the trading of pharmaceutical products. Coordinate with relevant regulatory team and sites to ensure compliance with all regulatory requirements related to API trading and export activities. Reporting and Analysis: Prepare regular reports on sales performance, market trends, and client feedback for management review. Analyze data to identify areas for improvement and implement corrective actions as needed. Preferred candidate profile B-Sc Chemistry, B Pharm or related specialization Minimum 6 to 8 years of experience in business development or marketing in pharmaceutical API Trading. Proven track record of achieving sales targets and developing client relationships. Ability to analyze market trends and data to inform business strategies. Must be Willing to travel domestically and abroad as and when required. Above par communication and analytical skill

Job Overview This is to upkeep the manufacturing assets to ensure availability and reliability,ensuring the smooth operation and reliability of equipment and facilities for the API plant Key Stakeholders: Internal Cross - functional teams at Digwal site like Production, QA, QC, HR, TSD, SCM , EHS, Administration etc Key Stakeholders: External Statutory and Regulatory agencies, External Suppliers, Engineering Contractors, Service providers & Customers (on need basis) Reporting Structure Role reports to: General Manager Engineering Experience 15-20 Years experience preferably in API plants Engineering and Maintenance (E&M) function. The incumbent should have exposure to managing Breakdown, Preventive maintenance, troubleshooting related API manufacturing. Blocks, Clean Rooms, HVAC, Utilities, Boiler, Electricals, Instrumentation and managing CAPAs. Should have academics understanding, operational know-how of Utilities, Electricals, Instrumentation, HVAC to maximize performance and optimizing OPEX into these areas. Should understand the KPIs of E&M function, working in matrix reporting environment to manage Corporate initiatives and Compliances. Have a passion and past exposure to drive for high standard of Safety and Compliance standard into day-to-day work, meeting EHS & statutory compliances and realizing zero incident performance Competencies: Ability to manage a large team and guide them to achieve functional objectives Stakeholder management internal and external Structured approach to manage overall E&M work and quick learning attitude to adapt cultural changes. High analytical abilities to spot on actual reasons for gaps in asset performance, energy performance and other E&M performances. Good level of understanding on Process oriented approach to designing and managing the work. Inter-personnel skills to work in matrix reporting, managing stake holders, working with Piramal Corporate Engineering. Multitask master to work in highly dynamic CMO Business environment. Key Role & Responsibilities: Responsible for Maintenance of API Plant with exposure to Mechanical, Electrical, Utilities and Instrumentation areas . Responsible for the complete E & M function to act as HOD in absence of HOD. Exposure to Utilities and Electrical efficiencies and to contribute into Energy efficiencies and ESG program. Jobs assigned time to time by HOD (E&M). He has been trained to perform Qualified Auditor. Responsible for internal Audits on time action closures as per the date & Agenda Circulated by QA & EHS. Develop & prepare work procedures to minimize OHS risks and Adverse environment effect. Comply with SHE Guidelines, SHE Rules and Regulations. Implement emergency control plan. Maintain all relevant records under OHSAS & EMS Systems. Ensure compliance to Hazardous waste and chemical management. Managing to complete observed unsafe acts and conditions and take corrective & preventive actions as per plan. Responsible for on time completion of all the maintenance work as per the satisfaction of end user. Responsible for in time payment of maintenance work carried out by fabricators & Contractors. Responsible for quality of maintenance work carried out by fabricators and contractors as per the specifications in timely manner. Responsible for carrying out breakdown investigation for any incident / accident/ near miss / illness and report if his superiors in two working days Responsibilities BE - Mechanical

Hi, Greetings Walk in Invitation: We are having face to face interview on 14th June Saturday in Mysore.- Single Round 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

About Company Global calcium is one of the leading API manufacturing company situated in Bangalore, India, specialised in speciality APIs, benzodiazepines, ophthalmics, oncology, chelated minerals and organic mineral salts of aspartate, citrate, gluconate, lactate, lactobionate, levulinate, orotate, pidolate , etc. We are hiring for multiple roles in the QC Department! Join us at Global Calcium Pvt. Ltd., a leading pharmaceutical manufacturer, and be part of a growing team committed to quality and innovation. Open Positions (Multiple Vacancies): QC ICP-MS Analyst (2 openings) Hands-on experience with ICP-MS instrumentation Knowledge of elemental impurity analysis and related regulatory guidelines QC - DMF Support (2 openings) Exposure to DMF preparation, review & support documents Understanding of regulatory documentation and compliance standards QC - Analytical Validation Support (2 openings) Knowledge of method validation techniques (HPLC/GC/UV) Experience in handling validation protocols and reports QC - Wet Analysis (2 openings) Proficient in classical wet chemistry techniques Experience in raw material and finished product testing Eligibility Criteria: B.Sc./M.Sc. in Chemistry or related fields 1 to 4 years of relevant pharmaceutical QC experience Good understanding of cGMP practices and regulatory compliance Willingness to work in a fast-paced manufacturing environment Walk-in Interview Details: Venue: Global Calcium Pvt. Ltd., Unit III, 19 & 19B, Sipcot industrial complex, Phase - 1, Dharga, Hosur Date: 14th June 2025 Time: 9:30 AM to 11:00 AM Documents to Carry: Resume, Recent Photograph, Last 3 Months Payslips, Educational & Experience Certificates, ID Proof Note: Only candidates with relevant experience in the pharmaceutical QC domain will be considered. Role & responsibilities Role Responsibilities Conduct routine and non-routine analyses using analytical techniques and instrumentation. Develop and validate analytical methods and protocols. Prepare and maintain detailed documentation and reports. Ensure compliance with regulatory guidelines and GMP standards. Collaborate with other departments for cross-functional projects. Actively participate in laboratory investigations and troubleshooting activities. Benefits and Perks As per industry standards

Recruiter Mohaneswara Reddy https://www.linkedin.com/in/mohaneswarareddy Role & responsibilities The responsibilities are Operations, Control and Monitoring 1. Improving, continuous reviewing and up gradation of existing production SOPs and work systems to ensure their strict implementation in respective block. 2. Resolution and identification of maintenance related activities of equipment and facility and making sure those are closed appropriately 3. Executing proposed changes in product, process or equipment and facility. 4. Preparing production plan and supervising the API and Intermediate batches as per production plan. 5. Ensure facility upkeep is maintained all the time. 6. Any other assignment given by management. 7. Communicating concerns with cross functional and service departments. 8. Control and monitor departmental opex budget. 9. Monitoring and controlling of effluent generation from manufacturing block. 10. Periodic review and monitoring of inventory in coordination with unit stores and supply chain. 11. Executing and monitoring of validation of new product, CIP, AVD with the help of cross functional team. 12. Implementation of new technology w.r.t. process equipments or facility. 13. Supporting quality assurance team for DMF submission. 14. Executing and supervising training, validation, qualification and calibrations protocols. 15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure. cGMP: 1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements. 2. Making sure all the documents and checklist are verified before and after manufacturing. 3. Ensuring retention and destruction of records are maintained in a department. 4. Verifying status labelling of accessories, in-process instruments, containers, area & equipment 5. Performing contemporaneous (on time) document entries. QMS / OTHER SOFTWARE SYSTEMS: 1. Operating software systems like SAP, Quality Management System, Track wise system, Cipdox software, PR approval, LMS, Ariba, PPDS and E-Track system etc. based on roles and rights provided in the applications. 2. Compiling Annual product quality review along with quality assurance department and other CFT. 3. Participating and contributing to investigation for any non-conformance along with CFT. EHS: 1. Following Environment, Health and Safety policies and practices. 2. Making sure personnel health, hygiene and organisation practices are followed. 3. To conduct risk analysis of product, system, equipment, process as per standard procedure. Training 1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS). Energy Management system (EnMS) 1. Participating in EnMS audits & Leadership rounds. Preferred candidate profile B.Tech Chemical with minimum 10 years of API production experience including experience to handle a block/section in a API plant.

This role involves following cGMP, safety, and environmental standards. The ideal candidate will have experience in API manufacturing, knowledge of regulatory guidelines, and a focus on quality and safety. Description: Strictly following cGMP, Safety and Environmental Practices. Filling of Batch Manufacturing record and equipment cleaning record. Following Good Manufacturing practices during operation. Ensuring Good Housekeeping in the respective plant area and its equipment. Usage of Proper personnel protective equipment as per requirement. Planning and ensuring RM availability for daily production as per production plan. Maintaining the documents like Issue and dispensing register. Carrying out the process as per BMR without any deviation. Ensuring the adherence to data Integrity in online documentation. Handling of Hazardous operation in safe manner. Effective utilization of resources like Utility, Men and Machine Qualifications: Degree in relevant field. e.g., Chemical Engineering/ Chemistry. Previous experience in a manufacturing or pilot plant environment is preferred. Strong understanding of cGMP, safety regulations, and good manufacturing practices. Excellent attention to detail and organizational skills. Ability to work collaboratively in a team-oriented environment. Strong communication skills, both verbal and written.

water purified water system operator is responsible for operating and maintaining a water treatment facility, ensuring that the water meets quality standards and is delivered safely to the community. This role involves monitoring equipment, performing maintenance, conducting tests, and adhering to regulatory requirements. Key Responsibilities: Operating Equipment: Operate pumps, valves, and other equipment to control the water treatment process. Monitoring Water Quality: Conduct regular tests and inspections to ensure water meets quality standards. Maintenance and Repairs: Assist in maintaining and repairing plant equipment. Data Logging: Maintain accurate records of water output, chemical analysis, and equipment usage. Safety: Adhere to safety guidelines and procedures to ensure a safe working environment. Troubleshooting: Help troubleshoot equipment issues and implement corrective actions. Compliance: Ensure compliance with regulatory requirements for water treatment and safety. Skills and Qualifications : Knowledge of water treatment processes and equipment. Effective communication and problem-solving skills. Ability to work in a team environment. Knowledge of safety regulations and procedures.

Responsibilities: * Collaborate with R&D on product development and launches * Meet revenue targets through strategic planning and execution market * Lead sales & marketing efforts for APIs in Europe, ROW * Manage customer relationships globally Provident fund Annual bonus

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.

Hii, Greetings from Avaniconsulting ! We are hiring for Production associate for a leading Pharma API Manufacturing company Position- Associate Work Experience Min 3-10 yrs in API Location - Mysore Gender - Any Qualification- B.Tech in Chemical Engineering /Msc Chemistry/Diploma Chemical/BSC Chemistry Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by Production head. if interested kindly share their updated resume with below details to priyanka@avaniconsulting.com or whatsapp to 9518220852 1. Current CTC: 2. Expected CTC: 3 . Notice Period: 4. Total Experience 5. Current Location: 6. Preferred Location: 7. Reason for change:

Role & responsibilities GurZac Biz Solutions Private Limited is assisting a renowned company in hiring for the position of Purchase Executive in an API manufacturing company to assist in the the procurement of raw materials, components, and other supplies needed for production . The role involves sourcing, negotiating prices, and ensuring the timely delivery of high-quality materials while adhering to regulatory standards. Sourcing & Supplier Management. Negotiation & Procurement Quality Control Cost Reduction Inventory Mangement Compliance Management Preferred candidate profile Must have minimum 2 years experience in purchase for API Manufacturing Company. Must be proficient in computers. Candidates available for early joining would be preferred.

Role & responsibilities Responsible for review of In process, Raw materials, Intermediates, Recovered materials, Finished products, Tech transfer samples and Cleaning verification / validation samples using current Specification, STP,GTP and associated wet chemistry and instrumental techniques as appropriate. Prepare and review specifications, sampling instructions, test methods, analytical work records and other QC procedures. Responsible for review of instrumental analysis as per the Matrix of analyst / microbiologist validation. Preparation and review of training matrix & training plan. Prepare and review cleaning validation / verification, Method validation, Method verification, Method transfer protocols and reports. Prepare and review study protocol and report for Quality control activities Preparation & review various quality documents such as SOPs, validation protocols and reports. Responsible for review of calibration of QC instruments like HPLC, Analytical Balance, Ultra Micro Balance, pH meter, Conductivity meter, UV spectrophotometer and refractometer etc Responsible for preparation, review, tracking of yearly calibration schedule, monthly calibration planner & preventive maintenance schedule. Ensure the tracking and follow up for the Method Validation, Verification & Analytical Method Transfer Activity. Planning and Execution of Method Validation, Verification & Analytical Method Coordinate with service engineer during preventive maintenance and breakdown of QC instruments. Responsible for verification of Laboratory chemicals, Reagents and Indicators. Review of logbooks in Quality Control Department and Responsible for monthly audit trial review for instrument. Preferred candidate profile Must have experience in Quality Control department in reputed pharma organizations. Should have hands on experience of Instrument Handling Strong knowledge of operating HPLC, GC, KF, IR, pH Meter etc. One Should Manage day to day Planning Should review method validation, Verification & Analytical Method Transfer Activity. One should timely review of calibration / verification of instruments. Ensure timely review preventive maintenance of instruments. Should review of records of QC testing. One should Timely review of logbook entries & daily monitoring activities.

As per R*D

Hii, Greetings from Avaniconsulting ! We are hiring for Production associate for a leading Pharma API Manufacturing company Position- Associate Work Experience Min 3-10 yrs in API Notice Period - 1 month ( maximum) Location - Mysore ( Nanjangud) Gender - Any Qualification- B.Tech in Chemical Engineering /Msc Chemistry/Diploma Chemical/BSC Chemistry Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by Production head. if intrested kindly share their updated resume with below details to mona@avaniconsulting.com or whatsapp to 7327039030 1. Current CTC: 2. Expected CTC: 3 . Notice Period: 4. Total Experience 5. Current Location: 6. Preferred Location: 7. Reason for change:

Candidate must have perfection in English communication. Knowledge of all regulated Guideline & Pharmacopoeia. Must have Knowledge all documentation of QA 18 to 20 Years in API Pharma Industry Experience

Role & responsibilities To establish the quality, health & safety policies, procedures, standards and specifications Maintain Certificate of Conformity for all our Products To work with the procurement team & production team to ensure quality standards To look at ways to reduce waste and increase efficiency; To set audit/ inspection procedures, protocol and checklist To conduct periodical inspections at the supplier location & also our warehouse for quality control, evaluate problems and suggest corrective action Focus on Continuous Improvement Preferred candidate profile Women candidate with Graduate in BSC Chemistry / B Pharma

Job Title: Site Head API Manufacturing Location: Dahej Reporting to: Head of Operations / Managing Director Job Summary: The Site Head will lead and oversee the entire operations of the API manufacturing facility, ensuring compliance with cGMP and regulatory standards while achieving operational excellence, cost-effectiveness, and timely delivery. This role is responsible for managing production, quality, EHS, engineering, supply chain, HR, and finance at the site level. Key Responsibilities: Strategic and Operational Leadership Provide leadership to all departments within the site to achieve strategic goals. Develop and implement operational strategies that align with business objectives. Drive continuous improvement, innovation, and lean manufacturing practices. Production & Supply Chain Management Ensure efficient production planning and execution to meet delivery timelines. Oversee inventory, procurement, and materials management. Coordinate with SCM for demand planning and logistics. Quality, Regulatory & Compliance Ensure compliance with GMP, regulatory, and statutory requirements (e.g., USFDA, EU, WHO, etc.). Partner with QA/QC teams to maintain high standards of product quality and documentation. Manage regulatory inspections and audits successfully. Engineering & EHS Maintain plant utilities, equipment, and infrastructure. Drive energy efficiency and sustainability initiatives. Ensure a strong EHS culture and compliance with safety norms. People Management Lead, mentor, and develop cross-functional teams. Drive employee engagement, learning, and performance management. Budgeting and Financial Control Prepare and manage site budgets. Monitor operational costs, identify cost-saving opportunities, and improve productivity. Qualifications: B.E./B.Tech (Chemical Engineering) or M.Sc. (Chemistry); MBA is an added advantage. 15–25 years of experience in API manufacturing, with at least 5 years in a site leadership role. Strong knowledge of GMP, ICH guidelines, and global regulatory frameworks. Proven track record in managing audits from international regulatory bodies. Key Competencies: Leadership and Decision-Making Strategic Thinking and Business Acumen Communication and Stakeholder Management Operational Excellence and Problem Solving Regulatory and Quality Compliance Interested candidate can share there cv at shardulsinh.k@cadilapharma.com

Role & responsibilities Preferred candidate profile

Job Purpose: To lead and manage all maintenance activities (mechanical, electrical, instrumentation, utility) across the API plant to ensure uninterrupted operations, compliance with regulatory standards, and optimal equipment performance. Key Responsibilities: 1. Preventive & Breakdown Maintenance: Develop and implement preventive maintenance schedules for all plant equipment. Ensure swift and effective response to breakdowns, minimizing downtime. Maintain documentation for all maintenance activities as per GMP requirements. 2. Utilities Management: Oversee the functioning and upkeep of critical utilities: boilers, chillers, air compressors, HVAC, WTP/ETP, etc. Ensure compliance with energy efficiency and sustainability practices. 3. Team Leadership: Manage a team of engineers, technicians, and contractors. Provide training and performance management to ensure high skill levels and motivation. 4. Compliance & Documentation: Ensure all maintenance practices comply with cGMP, FDA, WHO, and other regulatory bodies. Maintain audit-ready documentation (SOPs, logs, calibration records). 5. Project Management: Lead maintenance-related CAPEX projects including equipment installation, plant modification, or expansion. Coordinate with vendors, project teams, and contractors. 6. Budgeting & Inventory: Prepare and control maintenance budgets. Manage spare parts inventory and procurement. 7. Safety & Risk Management: Ensure all maintenance activities follow safety protocols. Conduct risk assessments and develop mitigation plans. Qualifications: B.E./B.Tech in Mechanical/Electrical/Instrumentation Engineering Certification in TPM, Six Sigma, or Lean Maintenance is an added advantage Experience: 12+ years in maintenance, with at least 5 years in a leadership role in an API or bulk drug manufacturing facility Proven expertise in managing utilities and compliance in a GMP-regulated environment Key Skills: Strong leadership and team management Hands-on experience with engineering utilities in API setup Familiarity with regulatory standards (GMP, USFDA, EHS, ISO) Problem-solving, planning, and organizational skills