236 Api Manufacturing Jobs - Page 6

Review DCS alarms. Ensure that batch charging and other manufacturing operations are strictly in accordance with the BMR/SOP and align with current GMP practices. Maintain manufacturing records online, ensuring compliance with data integrity practices. Collect samples of intermediate/in-process materials and send them to the IPQC/QC lab. Enter and verify production-related inputs in the SAP system. Review and ensure the generation of PISCADA reports. Transfer finished goods using the "Finished Goods Transfer Note." Monitor and ensure minimum stock levels of consumables, logbooks, and status labels. Ensure preventive maintenance of all equipment according to the schedule. Coordinate with service departments (QA, QC, Stores, E&M) for production-related activities. In case of any major abnormalities in the production area or activities, stop the activity immediately and inform superiors/production managers. Maintain housekeeping standards in the plant and ensure equipment cleanliness. Follow safety instructions/procedures and ensure the use of safety gear during work. Attend GMP and safety training sessions and implement the outcomes in the workplace. Conduct training for staff as a trainer. Be aware of the location and operation of firefighting equipment. Report any incidents or near misses in the MySafe portal. Rectify all safety and GMP-related observations. Do not leave the work area unattended or depart without prior permission from the manager. Manage the allocation of Isoflurane bulk to various customers. Participate in initiatives such as AET and CSR. Perform the duties of a senior in their absence or as authorized by a senior. Prepare and execute operational and performance qualification protocols. Prepare SOPs, BMRs, protocols, records, etc. Handle DocuSign and track related activities. Manage all QMS activities related to production.

Position : Assistant Manager- Production Location : Dahej Experience : 4-8 Years CTC Range : 5-9 LPA 1. Production Operations: Check and verify labels of raw materials, packing materials, and solvents before usage. Maintain appropriate storage conditions of raw materials and intermediates in the plant. Ensure adherence to process conditions during batch processing as per BMR (Batch Manufacturing Records). Take instructions from Shift In-charge / Managers for batch charging and monitoring. Report any deviations or discrepancies in plant/process to the Shift In-charge immediately. Complete assigned production tasks within the stipulated time. Maintain environmental conditions in the Production/Intermediate areas as per SOP. Perform reconciliation of accessories used in Production/Intermediate areas. Ensure zero contamination in the finished product. Perform packing and repacking activities as per operational requirements. Follow proper gowning and entry procedures in Production/Intermediate areas. Operate plant equipment and utilities as per operational SOPs. 2. Documentation: Complete online BPRs (Batch Processing Records), equipment usage records, and cleaning records accurately and timely. Maintain area pressure records, centrifuge bag records, and other documentation relevant to the Production area. Update equipment status boards and ensure the online completion of usage logs. Ensure proper labeling of fiber drums, hose pipes, and other batch-related tools. Ensure calibration of equipment such as weighing balances, pH meters, etc., as per SOP. 3. cGMP & Compliance: Guide and train workmen in the Finished Powder Processing section. Ensure the yield and quality of finished products meet predefined standards. Ensure packing of finished products is done as per SOP. Maintain cleanliness of the equipment and assigned production area. Participate in regular trainings to stay updated on cGMP, technical knowledge, and safety standards. Maintain and update personal training records regularly. Ensure reconciliation of intermediate products and cleaning materials. Remain aware of MSDS for all handled materials. 4. Safety, Health & Environment (EHS): Educate and supervise plant operators on safe chemical and equipment handling to prevent accidents. Coordinate with the EHS department for safety permits and compliance. Use scrubbers where required to prevent air pollution. Ensure no spillage of solvents and minimize material wastage. Shut off utility supply valves when not in use. 5. Interdepartmental Coordination: Coordinate with QC department for timely receipt of analysis reports. Coordinate with Engineering Services for any maintenance work required during the shift. Interested Candidate Please share your CV on Gmail- meet.chauchan@cadilapharma.com and also fill the detailes in the given link below: https://docs.google.com/forms/d/e/1FAIpQLScIYJJHOYg-KHEYPPmJXeN7e22-6-4spVE1BbsCG9E_XftzMQ/viewform?usp=header

Position Overview: We are looking for a highly skilled and experienced Senior Design Engineer with 5-10 years of expertise in designing downhole tools to join our dynamic team in Khopoli, Mumbai. The ideal candidate will have a proven track record in engineering design, a deep understanding of downhole tool technologies, and a passion for driving innovation in the oil and gas sector. Key Responsibilities: -Lead the design and development of advanced downhole tools and equipment, ensuring compliance with industry standards and customer requirements. -Utilize advanced engineering software and tools to create detailed design models, simulations, and prototypes, with a focus on innovation and performance optimization. -Oversee and mentor junior engineers and design teams, providing guidance and support throughout the design process. -Collaborate with cross-functional teams, including manufacturing, quality assurance, and field service, to ensure designs are practical, manufacturable, and reliable. -Review and refine existing designs based on field data, feedback, and technological advancements, ensuring continuous improvement. -Prepare and present comprehensive design documentation, including specifications, drawings, and technical reports. Qualifications: -Bachelors degree in Mechanical Engineering or Petroleum Engineering, -5-10 years of experience in design engineering with a strong focus on downhole tools. -Expertise in CAD software (e.g., SolidWorks, AutoCAD) and other advanced engineering design tools. -In-depth knowledge of downhole tool design principles, materials, and manufacturing processes. -Excellent problem-solving abilities, with a track record of innovative and effective design solutions. KNIOWLEDGE IN SOLID WORKS IS IMPORTANT. PEOPLE WITH EXP{ERIENCE IN OIL & GAS FIELD PREFERRED. GENUINE PEOPLE WHO ARE READY TO RE-LOCATE TO BANGALORE ONLY APPLY Perks and benefits As per industry standards

Lead research and development of APIs, excipients, and formulations. Optimize existing formulations and explore new product ideas. Conduct laboratory research, testing, and documentation. Collaborate with QC, production, and regulatory teams. Required Candidate profile Min 10 years of R&D experience in the pharmaceutical sector. Strong knowledge of formulation science, GMP, and regulatory norms. Skilled in analytical techniques, lab procedures, and instrumentation.

Must Have knowledge API Pharma, Excipients, or Chemicals Manufacturing sales across Gujarat Region

We are hiring for Senior Manager Marketing for a leading company specialized into manufacturing of Active Pharmaceutical Ingredients (APIs) and Drug Intermediates. Location : Mumbai Role & responsibilities : Hands on Experience in handling Exports of Bulk drugs (API's) & Intermediates to Latin markets, Europe, Asian & Middle East countries. Market intelligence in the field of API market, competitor analysis and identifying key prospect clients for the business. To understand the business strategy across the Sales & Marketing function & also to retain existing clients. To develop new customer base and expand business with potential partners and to keep them engaged. Branding and Marketing of the company product through social media or other marketing tools Interfacing between customers and the company for facilitating smooth order execution and handling the entire business cycle from quotation to closing the business deals with receivables. Coordinating with other departments such as production for material delivery planning, QA, QC for material analysis & qualification, Regulatory for supporting technical documents, Finance for payments & commissions, Sales & Logistics for timely shipping documents to shipment tracking, custom clearance etc. To manage & measure the assigned sales segment with the appropriate budget. Provide timely feedback relating to new business, renewals of existing customers and sales pipeline and performance against the targets. Strategizing pricing based on market analysis, to collate information of niche segment products and internal profitability. Coordination with Account & Finance, Production, RA,QA & QC, Plant Stores & Logistic, Procurement. Requirements: Bachelors Degree (Science or Pharma preferred) Minimum 12 years of experience in API/Bulk Drug Export Marketing Strong understanding of international markets and regulatory norms Excellent communication, coordination, and negotiation skill If interested, kindly share your resume at poonam@r2rconsults.com

Operate and monitor Solvent Recovery/ API manufacturing equipment and Instrument, such as distillation column, reboiler, condenser, reactor, Centrifuge, Dryer, Miller, sifter etc. Maintaining accurate records and documentation of production/ solvent recovery activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR) records, Solvent Recovery Record (SRR), Equipment s usage logs and Deviation reports if, any. To co-ordinate with engineering department for the shift break down jobs. To monitor the utility operation in the plant and report any abnormality to engineering department. Collaborate with other shop floor personnel, and cross-functional teams to ensure efficient and coordinated production/ Solvent recovery. Before charging of batch, cleanliness of Equipment s to be verified by visual verification procedure. To maintain good housekeeping in respective manufacturing area during process. Receive, store, and handle raw materials, intermediates, finished products, mother liquor, recovered solvent. Maintain accurate reconciliation records and follow proper material handling procedures. Follow established procedures to maintain product/ solvent quality and consistency. This may involve sampling and testing intermediates, raw materials, finished products and recovered solvent. To monitor the process/ unit operation online and record/fill the entire document legible. Continuously monitor & maintain process parameters as per the desired product/ Solvent specifications and quality. To record and maintain all the documents online as per CGMP. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), Solvent Recovery Record (SRR) and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To monitor and record temperature, Humidity and differential pressure in clean area (Level-I, Level-II & III). To check and record daily weighing balance calibration and verification. To take training online in AIMS software. Participate in training programs to enhance knowledge and skills related to API/Intermediate s manufacturing, Solvent Recovery and safety point of view. Adhere to and promote safety practices, including the use of personal protective equipment (PPE) and following safety procedures to prevent accidents or incidents. Be prepared to respond to emergencies, such as spills, leaks, or safety incidents, by following established emergency procedures. Participate in equipment cleaning and maintenance activities to ensure equipment is in good working condition. Identify and address issues or deviations in the manufacturing/ solvent recovery process, such as equipment malfunctions or variations in product/ solvent quality. Comply with environmental regulations, including proper waste disposal and following procedures for managing hazardous materials. Identify opportunities for process optimization, efficiency improvements, and waste reduction and communicate suggestions to higher-level personnel. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. To plan and procure, evaluate, and control on the inventories of Raw materials/ Packaging materials as per production requirements. To ensure materials receipt/storage/dispensing at Warehouse are done as per defined procedures with refer to respective MSDS and follow safety requirements. To ensure the weighing balances verification/calibration in Warehouse is done as per respective SOP. To ensure environment condition of dispensing area in Warehouse is as per respective SOP. To be performed necessary documentation work during the material dispensing activity as per respective SOP. Responsible for receiving mother liquor/ spent solvent/ layer/ distilled or recovered solvent and residue from production blocks, processing them through distillation for solvent recovery, and ensuring proper dispensing and storage of the recovered solvents as per standard operating procedures. To prepare and review manufacturing department related documents as per requirement.

Role & responsibilities Documentation & Records Maintain and regularly update all Quality Control (QC) registers. Review and ensure accuracy of in-process sample analysis registers. Maintain records for raw materials (RM), packing materials (PM), and finished product QC reports. Document and maintain daily calibration records of laboratory instruments. Maintain and review stability data records and product shelf-life records. Manage retain sample records including expiry and discard documentation. Maintain Food Safety records relevant to QC operations. Sample Analysis Perform and troubleshoot analysis of raw materials, intermediates, and finished products. Ensure accurate analysis control for all types of samples. Manage and document stability sample analysis. Calibration & Method Standardization Plan, execute, and record calibration of all laboratory instruments, including data with/without calibration results. Finalize reagent solution normality. Prepare and standardize volumetric solutions; maintain related records. Validate and document analytical methods and specifications. Quality & Food Safety Management Maintain FSSC-22000, FSMS, HACCP manuals and quality plans for RM, IP, PM, and FP. Conduct validation of processes (FBD, blender, assay, analyst) and review data. Ensure SOP preparation, periodic review, approval, and compliance. Maintain product specifications, traceability, and labelling control. Audits & Compliance Conduct internal audits and maintain audit plans and records. Participate in management review meetings (MRM), including agenda preparation and report generation. Coordinate with external testing labs and review outsourced activity contracts. Training & Team Coordination Prepare training calendars and maintain training and effectiveness records. Manage HACCP team reviews, employee skill matrix, and food safety awareness programs. Customer & Vendor Interface Handle vendor evaluation and selection records. Manage customer feedback, product dispatch planning, and rework/reprocess activities. Performance & Data Review Analyse yield loss trends, quality control reports, and external test report data. Ensure calibration and monitoring of measuring devices and lab instruments. Policy & Regulatory Compliance Maintain organization policies, quality policy, and organizational charts in compliance with regulatory requirements. Preferred candidate profile M.Sc. in Chemistry having5-10 Years Experience in QA/QC handling instrument HPLC,GC in Chemical and Pharmaceutical Industry having problem-solving and decision-making skills, Strong analytical and organizational skills. Additional Information: At Avid Organics, we believe that we can achieve our mission to enhance value creation for our stakeholders only through the quality and commitment of our people. We continuously strive to unleash the potential of each individual. We leverage human capital for competitiveness by nurturing knowledge, entrepreneurship, and creativity. These strengths help us compete successfully in a global business environment and exploit emerging opportunities. We reward the will to succeed and the desire to compete with the best in the world. Our employees are intellectually stimulated and given the freedom to make their own decisions, driving our growth through innovation and experimentation. Apply Now! :- hr@avidorganics.net Visit our website or contact us at https://www.avidorganics.net Job Location: Survey No. 460/1,,,GEB SUB STATION ROAD,,POICHA-Ra nia, Ta.- Savli , VADODARA, Gujarat, India

Ideal candidate will prepare error-free DMF submissions to regulatory authorities. Manage amendments and annual reports, address regulatory queries, ensure compliance in development/validation, assess impurities. Required Candidate profile Please apply only if your qualifications match the requirements.

Company Name: Oneiro Lifecare Pvt Ltd Designation: Asst Manager/ Dy Manager Job Location: Ekalbara, Vadodara Role & responsibilities Lead and manage process development, scale-up, and technology transfer activities. Provide the Documents, P&ID, PDF, PDS, and Material & Energy Balance, costing sheet to New Products as well as Existing Products Optimize process parameters to improve yield, quality, and productivity. Troubleshoot process-related issues and ensure smooth production operations. Work closely with R&D, QA, QC, EHS, and production teams. Conduct risk assessments, HAZOP studies, and implement process safety measures. Support new product introductions and validation activities. Ensure compliance with cGMP, regulatory guidelines, and internal SOPs. Develop and maintain process documentation such as PFDs, P&IDs, batch records, etc. Identify and implement cost-saving initiatives and energy optimization. Train and mentor junior process engineers. Preferred candidate profile 10+ years of experience in Process Engineering in the Pharma / API industry . Strong knowledge of chemical unit operations and equipment (reactors, centrifuges, dryers, etc.). Hands-on experience in tech transfer , scale-up , and cGMP processes. Excellent analytical, problem-solving, and communication skills. Proficient in MS Office, AutoCAD, or other process simulation tools is an advantage. Should be familiar with safety and environmental regulations.

Hi, Greetings from Avani Consulting!!! Walk in Invitation: We have job opportunity with API Manufacturing Plant for Associate /Sr. Associate Production Profile for Mysuru Loaction. Interview Location BANGALORE We are having face to face interview on 21st June Saturday in Bangalore.- Single Round Face to face Company : A leading Pharma API Unit - in Mysore Position - Production Department Associate /Sr. Associate Work Experience Min 5 yrs in API in current Salary 20% to 25 % hike on current CTC. Note: No Charges If interested drop your CV to Shweta Gupta [ 7015954549|| shweta@avaniconsulting.com ] Thanks & Regards Shweta Gupta

Urgently Hiring Diploma chemical for production department job for pharma industry. Company: Pharma API Industry Designation: Production Trainee (3 shift Job) Salary : 15k - 20K ( depending on your interview performance ) location - Mysore (Nanjangud) If interested kindly share your resume to 7327039030 or mona@avaniconsulting.com With the below details: 1. Name: 2. Highest Qualification: 3. Passing Year: 4. Percentage marks obtain: 5. If okay with the shift job: 6. If okay with the job location: 7. Current Location: 8. Contact number: 9. Email id:

1. Should be handle instrument activity of project 2. Should know the cGMP awareness related to project 3. Document Handling (DQ,IQ,PQ) Kindly share your updated CV on sneha.shinde@embio.co.in & kchoudhary@embio.co.in

Managing all production activities during the assigned shift. Operating equipment’s Reactors, Centrifuges, and Dryers. Ensuring adherence to SOP, GMP and other relevant regulations. Maintain accurate production records, Online BMR, BPCR feeling.

Experience in chemical industry Salary based on interview & Experience

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 monitor the utility operation in the plant and report any abnormality to concern department. 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 condition. To check before charging of batch, visual verification of cleanliness status of process equipment. 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 / M.Sc. Chemistry B.E or B.Tech Chemical Engineering Expereince : 2 to 8 Years Perks and benefits Best in the Industry

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled with experience in process validation and variation submissions. Your responsibilities will extend to maintaining robust electronic document management systems (EDMS) and ensuring manufacturing records align with regulatory requirements. This position demands a proactive individual with excellent communication skills to effectively liaise with regulatory agencies and internal stakeholders, ensuring Synnat Pharma maintains its commitment to quality and compliance in the pharmaceutical industry. Job Details: Industry: Pharmaceutical (API Division) Department: Regulatory Affairs Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 5,00,000 - 10,00,000 INR per annum Experience: 5-9 years Qualification: Bachelor's degree in Pharmacy, Chemistry, or related field Responsibilities: R egulatory Submissions & Documentation: Prepare, review, and submit comprehensive regulatory dossiers and technical documentation for API products to various health authorities (US FDA, EMA, CDSCO). Manage the compilation, archiving, and tracking of all regulatory documentation using electronic document management systems (EDMS). Ensure all regulatory submissions are accurate, complete, and compliant with current regulatory guidelines and requirements. Maintain up-to-date knowledge of changes in pharmaceutical regulations and guidelines and communicate these changes to relevant stakeholders. Prepare and manage Drug Master File (DMF) filings, renewals, and updates, ensuring timely submissions and compliance. Coordinate with cross-functional teams (manufacturing, quality control, R&D) to gather necessary data and documentation. Regulatory Compliance & Inspections: Lead and manage regulatory inspections conducted by health authorities, ensuring preparedness and compliance. Develop and implement corrective and preventive actions (CAPA) in response to inspection findings and regulatory queries. Conduct internal audits to ensure compliance with pharmaceutical regulations and quality standards related to API manufacturing. Review manufacturing records and analytical data to ensure compliance with regulatory requirements and guidelines. Monitor and ensure adherence to pharmacopeias (USP, EP, BP) and ICH guidelines in API manufacturing processes. Maintain a thorough understanding of API manufacturing regulatory compliance. Regulatory Communication & Liaison: Act as the primary point of contact for communication with regulatory agencies regarding submissions, queries, and inspections. Prepare and manage responses to regulatory queries and deficiency letters, ensuring timely and accurate information. Liaise with internal stakeholders to address regulatory issues and provide guidance on compliance matters. Communicate regulatory updates and changes to relevant departments. Cultivate and maintain positive relationships with regulatory agencies. Provide support and guidance to cross-functional teams on regulatory expectations. Variation & Renewal Management Prepare and submit variation applications for changes to approved API manufacturing processes and formulations. Manage the renewal process for existing regulatory approvals, ensuring timely submissions and compliance. Assess the impact of proposed changes on regulatory filings and ensure appropriate documentation is prepared. Track the status of variation and renewal applications and communicate updates to stakeholders. Ensure all variations and renewals align with current regulatory guidelines. Maintain a comprehensive record of all variations and renewals submitted General Expectations and Past Experiences: Possess a Bachelor's degree in Pharmacy, Chemistry, or a related scientific field. Demonstrated experience (6-9 years) in regulatory affairs within the pharmaceutical industry, specifically in API manufacturing. Proven expertise in preparing and managing DMF filings and regulatory submissions for global health authorities (US FDA, EMA, CDSCO). Strong knowledge of pharmaceutical regulations, ICH guidelines, and pharmacopeias (USP, EP, BP). Experienced in regulatory inspections and responding to regulatory queries and deficiency letters. Proficient in EDMS and other relevant documentation systems. Excellent communication, interpersonal, and problem-solving skills with the ability to work cross-functionally.

Role: Chemist / Sr Chemist Department: Production Location: Bidar About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opportunity practices across all levels. Summary of Job: To execute the production through the various stages of manufacturing as per the plan and ensure compliance to quality, safety & regulatory requirements. Key Responsibilities : Execute production batches as per plan. Preparation of SOPs. To maintain the yield of products in specifies limits at various stages of process activities. Online verification of cleaning area / equipment and completion of Logs. Online monitoring of environment conditions and completion of Logs. To comply with cGMP standard during the entire process activity. Manufacturing of products as per cGMP. Online completion of batch process records. To maintain the process facility as per the regulatory norms. Experience/Qualification: M.Sc/ B.Sc/ B.Tech/ Diploma (Chemistry/Chemical) with 2-8 years of relevant industry experience. Key Competencies (Technical, Functional & Behavioural): Sound knowledge on theoretic aspects of Chemical Engineering Basic knowledge of API process and handling production machinery of manufacturing. Good interpersonal Skills

Position Assistant Manager-QA Function QA Location Bharuch;;;;;;; Reports to Head QA Summary of Job (Purpose/ objective of the job Department organogram to be enclosed) To check the Quality Assurance of the products and ensure compliance with the SOP's. Key Responsibilities (Performance Indicators) Quality professional of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement and API Manufacturing, Quality Management System (QMS), Qualification, Validation and other Manufacturing functions.; Documentation and Handling i.e.: Integrated Management System (IMS) (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018), WHO-GMP, FSMS (ISO 22000), FAMI-QS, Energy Management System (EnMS), Halal, Kosher and Responsible Care and 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 and utility system qualification. Issuance and retrieval of Batch Manufacturing Records. Control and Issuance of formats. Ensure that retention of various documents, reports and records are as per documented procedures. Issue copy of Master Batch Production Instructions to production for batch manufacture and review critical control parameters before release of the batch. No. of Reportees NA Qualification and Experience M.Sc Organic Chemistry with 3-6 yrs Key; Competencies ( Technical, Functional and Behavioral) Integrated Management System (IMS) (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018), WHO-GMP, FSMS (ISO 22000), FAMI-QS, Energy Management System (EnMS), Halal, Kosher and Responsible Care and regulatory (FDCA, USFDA, MHRA). Knowledge of validation process. Practical experience in documentation as per various audits. Approval VP - Mfg Unit HR

Head of Engineering & Maintenance- will lead all engineering and maintenance operations for a large-scale API pharmaceutical plant. This role is responsible for ensuring the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. The position requires extensive experience in API manufacturing, including expertise in CGMP, FDA regulations, and managing regulatory audits. Develop and execute maintenance strategies, drive continuous improvement, manage OPEX budgets, and lead a high-performing team to ensure safe, efficient, and compliant plant operations. LOCATION: Digwal, Hyderabad REPORTING STRUCTURE: Reports to Global Engineering & Project head & Site head , Direct reportees all plant engineering & maintenance team ESSENTIAL QUALIFICATION: Bachelors degree in Engineering (Mechanical, Electrical, or related field) RELEVANT EXPERIENCE: > 20 years in a Pharmaceutical API Facility Leadership & Strategy: Lead, manage, and develop the Engineering & Maintenance team to drive plant operational excellence. Develop and execute a comprehensive maintenance strategy, ensuring a proactive approach to maintenance, asset integrity, and equipment reliability. Drive continuous improvement initiatives to optimize plant performance and reduce unplanned downtime. Manage operating expenditure (OPEX) budgets for Engineering & Maintenance activities. Maintenance & Reliability Management : Ensure all critical equipment and systems are maintained in optimal condition to meet production goals and regulatory requirements. Oversee the implementation of preventive and predictive maintenance programs, improving plant uptime and reliability. Develop and implement a comprehensive asset management strategy, including lifecycle management for critical equipment. Regulatory Compliance & Safety : Ensure all maintenance activities are compliant with GMP, FDA, and other relevant pharmaceutical regulations. Promote a culture of safety and adherence to the highest environmental, health, and safety (EHS) standards. Lead the investigation and resolution of any maintenance-related incidents, ensuring timely and effective corrective actions. Team Development & Talent Management : Mentor, train, and develop Engineering & Maintenance personnel, ensuring their skills and capabilities meet the evolving needs of the plant. Foster a culture of collaboration, teamwork, and continuous learning within the team. Lead recruitment efforts to fill skill gaps within the department and drive talent development initiatives. Collaboration & Cross-Functional Coordination : Work closely with Production, Quality, and Supply Chain departments to ensure alignment between maintenance schedules and production plans. Collaborate with the plant leadership team to identify opportunities for process optimization, cost reductions, and productivity improvements. Technology & Innovation : Identify and implement new technologies that improve equipment performance, reduce maintenance costs, and enhance production efficiency. Stay current with industry best practices, technology advancements, and emerging trends in pharmaceutical manufacturing and maintenance Key Competencies: Must have extensive experience in API pharmaceutical manufacturing, with a deep understanding of CGMP, FDA regulations, and other regulatory audit requirements. Expertise in ensuring compliance with these standards while optimizing maintenance strategies and driving operational improvements is essential. The role requires a strong track record in managing audits, addressing non-conformities, and maintaining a high standard of product quality and safety.

Qualifications: M.Sc./ B.E - B.Tech (Chemical Engg.) •1 to 4 years of experience. •Experience in handling critical equipment like reactor, centrifuge, blender, sifter, multi-mill, etc. • • Job Responsibilities: Ensure that the products are manufactured as per the cGMP. Maintain documentation as per regulatory authorities requirements like change control, and deviations. Highlight technical problems and take corrective actions. •

Roles and Responsibilities Monitor and maintain accurate records of production processes, including batch tracking and inventory management. Collaborate with cross-functional teams to resolve issues related to productivity, yield improvement, and equipment maintenance.

Role & responsibilities Trainee Production Chemist Preferred candidate profile B.Sc or M.sc 2024-25 passout candidates willing to work in Production Departmant only can apply .

Key Responsibilities: • To drive and manage the P&L of the assigned products. • Open new gateways to markets for pharmaceutical APIs by leveraging existing networks and creating strategic entry points. • Initiate and negotiate client partnerships with pharmaceutical/drug companies and other relevant stakeholders. • Identify and capitalize on new business opportunities in the API market, ensuring alignment with company goals. • Build strong connections within the pharmaceutical industry to enhance market presence and drive partnerships. • Provide valuable insights on market dynamics, including emerging trends, competitive landscape, and regulatory requirements, to inform strategy. • Work closely with internal teams to align production, supply chain, and marketing efforts with market demands. Requirements: • Must have international exposure in Pharma API business with proven experience in similar leadership roles. • Minimum 15-20 years of proven experience in the pharmaceutical API industry. • In-depth knowledge of the API market and key players. • Strong existing network of industry contacts to facilitate market entry. • Demonstrated success in opening new markets and driving strategic partnerships. Role & responsibilities

Key Responsibilities: • To drive and manage the P&L of the assigned products. • Open new gateways to markets for pharmaceutical APIs by leveraging existing networks and creating strategic entry points. • Initiate and negotiate client partnerships with pharmaceutical/drug companies and other relevant stakeholders. • Identify and capitalize on new business opportunities in the API market, ensuring alignment with company goals. • Build strong connections within the pharmaceutical industry to enhance market presence and drive partnerships. • Provide valuable insights on market dynamics, including emerging trends, competitive landscape, and regulatory requirements, to inform strategy. • Work closely with internal teams to align production, supply chain, and marketing efforts with market demands. Requirements: • Must have international exposure in Pharma API business with proven experience in similar leadership roles. • Minimum 15-20 years of proven experience in the pharmaceutical API industry. • In-depth knowledge of the API market and key players. • Strong existing network of industry contacts to facilitate market entry. • Demonstrated success in opening new markets and driving strategic partnerships. Role & responsibilities