We are looking for a meticulous Warehouse Executive to optimize warehouse operations at Synnat Pharma Private Limited. As Warehouse Executive, you will play a crucial role in managing the daily operations of our warehouse, ensuring the safe and efficient receipt, storage, and dispensing of raw materials, solvents, and intermediates to production, as well as the dispatch of finished goods. This position requires maintaining strict inventory accuracy, adhering to Good Warehousing Practices (GWP) and Good Distribution Practices (GDP), and ensuring compliance with all relevant pharmaceutical regulatory requirements. The ideal candidate will possess a strong understanding of ERP systems, GRN preparation, and warehouse equipment maintenance. You will also be responsible for monitoring environmental conditions, managing documentation, and participating in warehouse audits. Your role is critical in upholding product quality and safety, supporting our commitment to excellence in the pharmaceutical industry. If you are a detail-oriented professional with a passion for operational efficiency and regulatory compliance, we encourage you to apply and contribute to our continued success. Responsibilities: Oversee daily warehouse operations, ensuring efficient receipt, storage, and dispatch of materials. Manage the flow of raw materials, solvents, and intermediates to production, and finished goods for dispatch. Maintain accurate records of raw materials, solvents, intermediates, and finished goods using ERP systems. Conduct regular inventory audits to ensure accuracy and identify discrepancies, implementing corrective actions. Maintain product quality and safety through effective warehousing and distribution practices (GWP and GDP), adhering to Synnat Pharma's quality standards. Ensure compliance with pharmaceutical regulatory requirements (GMP) and internal quality standards, actively participating in audits (USFDA, MHRA) and leading preparations as required. Manage the storage of materials under required temperature and humidity conditions, monitoring and addressing any excursions promptly. Ensure safe handling and storage of solvents, adhering to all safety protocols and regulations, including proper labeling and identification of all materials. Coordinate with procurement and production teams to ensure timely availability of materials, managing material expiration dates and obsolete stock disposal in compliance with environmental regulations. Manage the Goods Received Note (GRN) process from preparation to QC intimation of incoming materials, ensuring compliance with traceability requirements. Prepare and submit regular reports on warehouse operations, inventory levels, and compliance activities, maintaining all records in accordance with regulatory requirements and company policies. Ensure proper operation and maintenance of warehouse equipment, such as forklifts and pallet jacks, and oversee the calibration and performance verification of weighing balances and other measuring equipment. General Expectations and Past Experiences: Bachelor's degree with 4-7 years of experience in warehouse operations/regulatory audit within the pharmaceutical industry, preferably in API. Experience and Knowledge of Regulatory Audit and Customary Audit parameters is preferred. Proven expertise in Warehouse Operations Management, Materials Management, and Inventory Control using ERP Systems (SAP, Oracle). In-depth knowledge of Good Warehousing Practices (GWP), Good Distribution Practices (GDP), and Pharmaceutical Regulatory Requirements (GMP). Hands-on experience in Finished Goods Handling, Raw Materials Management, Intermediates Management, and Solvent Handling. Ability to prepare and manage Goods Received Note (GRN) from preparation to QC intimation, ensuring accuracy and compliance. Excellent communication skills in English, Hindi, and Telugu, with the ability to work independently and collaboratively. Willingness to work flexible hours and participate in warehouse audits, demonstrating a commitment to maintaining high standards.
We are looking for a meticulous Senior Executive or Assistant Manager to lead regulatory filings at Synnat Pharma Pvt Ltd, a rapidly expanding company in the Active Pharmaceutical Ingredient (API) industry. In this pivotal role, you will be instrumental in navigating the complex landscape of pharmaceutical regulations, ensuring our API products meet the stringent requirements of global regulatory bodies, particularly the US FDA. Your expertise will be crucial in preparing and submitting Drug Master Files (DMFs) and eCTD-compliant documentation, managing regulatory inspections, and proactively mitigating regulatory risks. You will collaborate closely with API manufacturing, quality control, and research teams to develop and implement robust regulatory strategies. Responsibilities will also include conducting regulatory audits, ensuring adherence to ICH guidelines, and managing the lifecycle of API products from a regulatory perspective. A deep understanding of pharmaceutical regulations, coupled with the ability to interact with regulatory authorities, will be essential for ensuring compliance and expanding into regulated markets. Job Details: Industry: Active Pharmaceutical Ingredients (API) Department: Regulatory Affairs Role: Senior Executive / Assistant Manager Regulatory Affairs Location: Visakhapatnam Compensation: 5 to 10 LPA Experience: 7 to12 years Employment Type: Full-time Qualification: Bachelors or Master’s degree in Pharmacy, Chemistry, or a related field Responsibilities: Prepare, review, and submit comprehensive regulatory filings including DMFs, variations, and renewals, ensuring compliance with global regulations. Manage the eCTD compilation and submission process for API products, ensuring accuracy and adherence to timelines. Lead documentation preparation for regulatory inspections, responding to queries from authorities. Conduct regulatory audits of API manufacturing processes to ensure compliance with cGMP requirements. Develop and implement CAPA plans to address regulatory gaps or deficiencies. Monitor and track the status of filings, proactively addressing issues to secure timely approvals. Develop regulatory strategies for API products, considering market access requirements and regulatory trends. Identify and mitigate regulatory risks, ensuring compliance with ICH and US FDA guidelines. Provide regulatory guidance and support to cross-functional teams and ensure change control compliance. Manage the regulatory aspects of API product lifecycle from development through commercialization and post-market surveillance. Collaborate with manufacturing, QC, and R&D teams to ensure compliance throughout the product lifecycle. Participate in product recalls, adverse event reporting, and lifecycle management activities. General Expectations and Experience: 7–12 years of proven experience in API Regulatory Affairs Strong knowledge of US FDA regulations, ICH guidelines, and cGMP compliance. Hands-on expertise in DMF preparation, eCTD submissions, and regulatory audits/inspections. Experience in API manufacturing processes and documentation requirements. Excellent communication, documentation, and negotiation skills with regulatory authorities. Proficiency in Regulatory Compliance Management and change control processes.
We are looking for a meticulous Officer Technology Transfer to champion process validation and technology transfer activities at Synnat Pharma Private Limited. As a key member of our team, you will be instrumental in monitoring process validation batches, meticulously recording observed data, and identifying opportunities for process improvements within our API Manufacturing Industry. Your responsibilities will extend to collecting, updating, and correlating data to identify variations, contributing to the preparation of process validation documents such as Batch Manufacturing Records (BMRs), protocols, and reports. This role demands a proactive individual capable of working in shifts and collaborating effectively with cross-functional teams. The ideal candidate will possess a strong foundation in chemical engineering principles and a keen eye for detail, ensuring adherence to quality standards and regulatory requirements. You will play a critical role in the seamless transfer of technology and the continuous improvement of our manufacturing processes, contributing directly to Synnat Pharma's commitment to global leadership in the API sector. Job Details Industry: API Manufacturing Industry Department: Technology Transfer Role: Officer Technology Transfer Location: Visakhapatnam Experience: 0 years Employment Type: Full-time Qualification: Bachelor's degree in Chemical Engineering or related field Responsibilities Process Validation and Monitoring Monitor process validation batches meticulously, ensuring adherence to established protocols and procedures. Record and document all observed data, both qualitative and quantitative, with accuracy and attention to detail. Identify deviations from expected results and report findings to the superior for further investigation. Collaborate with production and quality control teams to troubleshoot process-related issues during validation runs. Ensure compliance with all relevant regulatory requirements and internal quality standards throughout the validation process. Analyze process validation data to identify trends and areas for process optimization. Data Collection and Analysis Collect data from various sources, including batch records, laboratory analyses, and process monitoring systems. Update and correlate data with previous data sets to identify variations and potential process inconsistencies. Analyze data to determine the root cause of process deviations and propose corrective actions. Prepare reports summarizing data analysis findings and recommendations for process improvements. Maintain accurate and complete records of all data collected and analyzed. Present data and findings to relevant stakeholders in a clear and concise manner. Documentation and Reporting Prepare process validation documents, including Batch Manufacturing Records (BMRs), protocols, and reports, in accordance with established templates and guidelines. Ensure all documentation is accurate, complete, and compliant with regulatory requirements. Maintain a comprehensive library of process validation documents for easy access and retrieval. Assist in the preparation of regulatory submissions related to process validation. Contribute to the development and maintenance of standard operating procedures (SOPs) for process validation activities. Generate periodic reports on the status of process validation activities. Technology Transfer Activities Participate in the transfer of technology from research and development to manufacturing. Assist in the development and implementation of technology transfer protocols. Ensure that all necessary documentation is prepared and maintained during the technology transfer process. Provide training and support to manufacturing personnel on new technologies and processes. Collaborate with cross-functional teams to ensure a smooth and efficient technology transfer process. Troubleshoot technical issues that may arise during technology transfer. General Expectations and Past Experiences Bachelor's degree in Chemical Engineering or a related field is essential. Demonstrated ability to work effectively in a shift-based environment. Proven ability to meticulously monitor process validation batches and accurately record observed data. Strong understanding of existing processes and the ability to identify areas for improvement. Proficiency in collecting, updating, and correlating data to identify variations. Experience in preparing process validation documents such as BMRs, protocols, and reports. Excellent teamwork and collaboration skills to work effectively with cross-functional teams.
We are looking for a meticulous Assistant Manager Plant Maintenance & Projects to spearhead plant maintenance and project engineering activities at Synnat Pharma. In this pivotal role, you will ensure the seamless operation of our API manufacturing facility in Visakhapatnam, minimizing downtime and maximizing efficiency. You'll lead a team of technicians and engineers, driving adherence to preventive maintenance schedules, troubleshooting critical failures, and implementing robust corrective actions. Your responsibilities will span across overseeing ongoing projects, managing budgets, coordinating with vendors, and ensuring strict compliance with cGMP, safety, and environmental regulations. The ideal candidate will possess a strong foundation in mechanical/electrical engineering, coupled with hands-on experience in plant maintenance, project management, and a commitment to continuous improvement. This role demands a proactive approach, excellent problem-solving skills, and the ability to thrive in a dynamic pharmaceutical manufacturing environment. If you are passionate about optimizing plant performance, driving operational excellence, and contributing to the growth of a leading API manufacturer, we encourage you to apply. Job Details: Industry: API Department: Plant Maintenance & Projects Role: Assistant Manager Location: Visakhapatnam Compensation: 7-8 LPA Experience: 5-7 years Qualification: B. Tech / M. Tech in Mechanical / Electrical/ Industrial engineering Employment Type: Full-time Responsibilities: Lead and supervise a team of technicians and engineers at Synnat Pharma, ensuring smooth plant operations and minimal downtime, fostering a collaborative and high-performance work environment. Monitor daily maintenance activities, ensuring adherence to preventive maintenance (PM) schedules and optimizing PM programs based on equipment performance data in our API manufacturing plant. Troubleshoot electrical/mechanical failures, perform root cause analysis (RCA) using methodologies like 5-Why or Fishbone diagrams, and implement effective corrective and preventive actions (CAPA). Implement and maintain an inventory tracking system for PM consumables and critical spares, optimizing stock levels to minimize downtime and reduce carrying costs, leveraging ERP systems. Ensure compliance with safety, environmental, and regulatory standards (e.g., cGMP, OSHA), conducting regular audits and implementing corrective actions to maintain a safe and compliant work environment at Synnat Pharma. Oversee ongoing projects (new installations, upgrades, expansions) from planning to commissioning, ensuring alignment with organizational goals and regulatory requirements in our API facility. Ensure projects are executed as per design specifications, within budget, and on schedule, employing project management methodologies (e.g., Gantt charts, critical path analysis) to track progress and mitigate risks. Coordinate with contractors, vendors, and suppliers for AMCs, spares, and services, negotiating contracts and ensuring timely delivery of quality products and services. Oversee the maintenance and operation of plant utilities, including HVAC systems, water treatment plants, and power distribution systems, ensuring reliable and efficient performance. Implement and monitor energy-saving opportunities, such as optimizing HVAC settings and upgrading lighting systems, contributing to sustainability goals and reducing operational costs at Synnat Pharma. Analyze maintenance costs and recommend cost-effective solutions, identifying areas for improvement and implementing strategies to reduce expenses without compromising quality or reliability. Prepare and manage the maintenance budget, tracking expenses, and ensuring adherence to budgetary guidelines, providing regular reports on financial performance. General Expectations and Past Experiences: Possess a Bachelor's or Master's degree in Mechanical, Electrical, or Industrial Engineering with 5-7 years of relevant experience in plant maintenance and project management within the pharmaceutical (API preferred) or a related industry. Demonstrate strong knowledge of preventive and predictive maintenance techniques, including vibration analysis, thermography, and oil analysis, with the ability to interpret data and implement effective maintenance strategies. Exhibit hands-on experience in troubleshooting electrical/mechanical systems, with the ability to diagnose and repair complex equipment failures efficiently and effectively. Show proficiency in project management principles and methodologies, with the ability to plan, execute, and monitor projects to ensure on-time completion within budget and to required quality standards. Demonstrate excellent communication, interpersonal, and leadership skills, with the ability to effectively lead and motivate a team of technicians and engineers. Familiarity with ERP systems (e.g., SAP, Oracle) and AutoCAD is highly desirable, with the ability to utilize these tools for maintenance planning, inventory management, and project design. Possess a strong understanding of cGMP guidelines and regulatory requirements for pharmaceutical manufacturing, with a commitment to maintaining compliance and ensuring product quality.
We are looking for a meticulous and proactive Assistant Manager - Utilities to champion the operation and maintenance of critical utility systems at Synnat Pharma. This role is pivotal in ensuring the seamless functioning of essential infrastructure, including boilers, cooling towers, refrigeration systems, AHUs, water treatment (RO/DM), and compressed air/nitrogen systems. As the Assistant Manager, you will blend hands-on site responsibilities with strategic office-based tasks, such as data capture and engineering calculations, to drive efficiency enhancement. The ideal candidate will possess a strong understanding of pharmaceutical manufacturing, API production, and regulatory compliance, with a focus on optimizing energy consumption and minimizing operational costs. You will lead a team of technicians and operators, ensuring adherence to SOPs and safety protocols, while also collaborating with vendors for AMC, spares, and service contracts. If you're passionate about utility system uptime and efficiency, and thrive in a dynamic environment, this is an excellent opportunity to contribute to Synnat Pharma's continued success. Job Details: Industry: API Manufacturing Department: Utilities Role: Assistant Manager - Utilities Location: Visakhapatnam Compensation: 6-7 LPA Experience: 4-5 years Qualification: B. Tech / M. Tech in Mechanical Engineering or specialization in Mechanical Engineering Employment Type: Full-time Key Words Defining the Job: Preventive Maintenance, Reliability Engineering, Energy Efficiency, Boiler Operation Engineer (BOE), Water Treatment Plants (RO/DM), Compressed Gas Systems, EHS Regulations, Vendor Management, Pharmaceutical Manufacturing, API Manufacturing, Fluid Mechanics, Refrigeration Systems, Utilities Management, PLC Systems, HVAC Systems, Thermodynamics, Air Handling Units (AHUs), Regulatory Compliance Responsibilities: Oversee boilers, cooling towers, and other utility systems for efficient operation. Conduct regular inspections to ensure optimal performance of utility equipment. Manage preventive maintenance programs to minimize downtime. Troubleshoot system failures and implement corrective actions. Coordinate with stakeholders to meet production demands and quality standards. Identify and implement energy-saving opportunities to reduce costs. Analyze utility data to identify inefficiencies and areas for improvement. Ensure compliance with EHS regulations, SOPs, and company policies. Conduct safety inspections and mitigate potential hazards. Coordinate with vendors for services, ensuring timely and cost-effective delivery. Manage procurement of utility equipment and consumables. Lead and train technicians, providing guidance and support. General Expectations and Past Experiences: Proven experience in managing and maintaining critical utility systems, including boilers, chillers, cooling towers, AHUs, water treatment plants (RO/DM), and compressed gas systems. Strong knowledge of API manufacturing processes and pharmaceutical industry standards, with a focus on utilities management. Hands-on experience with Preventive Maintenance, Reliability Engineering and Boiler Maintenance, ensuring equipment uptime and efficiency. Familiarity with SCADA/BMS Systems for monitoring and controlling utility operations, with practical experience in PLC Systems. Ability to conduct Risk Assessment and implement Change Management strategies to improve utility system performance. Excellent troubleshooting skills and ability to diagnose and resolve complex utility system issues, ensuring minimal downtime. In-depth understanding of Regulatory Compliance, EHS Regulations, and Process Safety Management related to utility operations.
We are looking for a meticulous Junior Engineer to contribute to the efficient maintenance and operation of our API manufacturing facility at Synnat Pharma. As a Junior Engineer, you will be integral to ensuring the reliability of our mechanical and electrical systems, contributing to our commitment to quality and compliance. This role involves a blend of hands-on equipment maintenance, detailed record-keeping, and active participation in equipment validation and qualification processes. You will collaborate closely with senior technicians and engineers, assisting in breakdown maintenance, equipment installation, and process improvement projects. Your dedication to following safety procedures, adherence to cGMP and GDP guidelines, and proactive approach to learning will be crucial to your success. You will also contribute to the creation and maintenance of SOPs, ensuring all maintenance activities align with regulatory requirements. If you are a motivated individual with a foundational understanding of pharmaceutical manufacturing equipment and a desire to grow your career in a dynamic API environment, this is an excellent opportunity to develop your skills and contribute to a leading pharmaceutical company. Job Details: Industry: API Manufacturing Department: Engineering/Maintenance Role: Junior Engineer - Mechanical Location: Visakhapatnam Compensation: 3.5 LPA Experience: 0-1 year Qualification: B.Tech in Mechanical/Electrical/Production Engineering Employment Type: Full-time Responsibilities: Conduct routine checks and perform basic repairs on pharmaceutical manufacturing equipment. Assist in troubleshooting and resolving equipment breakdowns. Oversee preventative maintenance schedules, ensuring adherence to protocols. Maintain accurate maintenance records, documenting all activities. Support instrument and equipment calibration, ensuring regulatory compliance. Participate in spare parts management, ensuring adequate inventory. Assist in the installation and testing of new equipment. Support validation and qualification activities, adhering to cGMP. Help prepare technical documentation related to equipment performance. Adhere to cGMP and GDP guidelines in all maintenance activities. Participate in product and process improvement projects at Synnat Pharma. Collaborate with cross-functional teams to address equipment issues. General Expectations and Past Experiences: Basic technical knowledge in Mechanical/ Electrical / Production engineering is essential. Proficiency in Telugu, Hindi, and English languages is required for effective communication. Familiarity with Equipment Maintenance, Equipment Installation, and Equipment Qualification processes. Knowledge of API Manufacturing, Preventative Maintenance, and SOPs is desirable. Willingness to learn new skills and adapt to evolving manufacturing processes. Good knowledge of MS Office applications for data capturing and reporting. Must be a team player with good communication and interpersonal skills.
We seek a meticulous Projects Executive to spearhead pharmaceutical project execution at Synnat Pharma. As a Projects Executive, you will be instrumental in ensuring projects are completed on schedule, within budget, and in strict adherence to pharmaceutical safety regulations and cGMP guidelines. This pivotal role demands a proactive individual capable of seamless cross-functional coordination, meticulous material management, and a deep understanding of cGMP principles. You will be deeply involved in project planning, fabrication supervision, vendor coordination, and risk assessment, ensuring the highest standards of quality and compliance. Your responsibilities will extend to preparing comprehensive project documentation, managing material indenting processes, and providing regular progress reports to stakeholders. This position offers a unique opportunity to contribute to a fast-growing pharmaceutical company and significantly impact its operational efficiency and regulatory compliance. If you are a detail-oriented professional with a passion for project management in the pharmaceutical sector, we encourage you to apply. Job Details: Industry: API Department: Projects Role: Projects Executive Location: Visakhapatnam Compensation: 3-4 LPA Experience: 2-3 years Qualification: B. Tech / M. Tech in Mechanical engineering or specialization in Chemical engineering Employment Type: Full-time Responsibilities: Assist in project planning and execution, ensuring alignment with timelines and budget. Supervise fabrication, ensuring adherence to drawings and specifications. Manage material indenting, ensuring timely procurement of materials. Prepare and maintain project documentation, including plans and reports. Coordinate with vendors to ensure timely delivery of materials and services. Identify and mitigate potential risks associated with project activities. Monitor project progress, identifying and addressing potential delays. Monitor fabrication quality, resolving deviations from standards. Verify material specifications against project requirements. Develop accurate records of project activities and technical documentation. Communicate project updates to stakeholders. Conduct risk assessments to identify new or emerging risks. General Expectations and Past Experiences: Possess a B.Tech/M.Tech in Mechanical or Chemical Engineering with 2-3 years of experience in pharmaceutical project execution. Demonstrate proficiency in Material Indenting Expertise and Fabrication Supervision & Quality Assurance. Exhibit strong Project Documentation & Reporting skills, including knowledge of cGMP requirements. Apply Risk Assessment & Mitigation Strategies effectively to ensure project success. Utilize Vendor Coordination & Negotiation skills to manage procurement and supply chain activities. Communicate fluently in Telugu, Hindi, and English, fostering effective Stakeholder Communication. Show a willingness to learn new skills and adapt to evolving project requirements, ensuring continuous professional development.
We are looking for a meticulous Warehouse Asst Manager to optimize our API warehousing operations at Synnat Pharma. As the Warehouse Asst Manager, you will play a crucial role in managing the receipt, storage, and dispatch of raw materials, packing materials, and finished goods, ensuring compliance with GMP and GDP standards. This involves maintaining inventory accuracy, overseeing dispensing procedures, and handling regulatory audits. You will supervise warehouse staff, manage customs activities, and ensure materials are stored and transported under appropriate conditions. The role demands a proactive individual capable of independently managing warehouse operations, maintaining stock levels, and preparing essential documentation like SOPs and deviation reports. Your expertise will contribute to maintaining high standards of safety, quality, and efficiency within our warehouse facility. If you have a strong background in pharmaceutical warehousing and a commitment to excellence, we invite you to apply. You will also have the opportunity to lead warehouse audits in certain cases. Responsibilities: Oversee daily warehouse operations, ensuring efficient receipt, storage, and dispatch of materials. Supervise and allocate tasks to warehouse staff, focusing on RM, PM, and FG management. Ensure compliance with GMP, GDP, and safety standards throughout warehouse activities. Maintain accurate inventory records and conduct regular stock audits. Maintain optimal stock levels of RM, PM, and consumables based on production needs. Manage materials receipt, storage, and dispensing under required environmental conditions. Verify warehouse temperature records and retest due dates for RM and PM. Ensure warehouse operations comply with GMP, GDP, and other relevant regulatory requirements. Manage customs activities and dispatch finished goods according to transit needs. Coordinate with logistics providers for timely and efficient material delivery. Maintain and enhance GDP and GMP standards within the Synnat Pharma warehouse. Review and approve warehouse documentation, including SOPs and deviation reports. General Expectations and Past Experiences: Possess a strong understanding of API warehousing practices and regulatory requirements. Demonstrated experience in managing warehouse operations, including receipt, storage, and dispatch of materials. Proficient in inventory control techniques and warehouse management systems (WMS). Experience in handling regulatory audits and ensuring compliance with GMP and GDP standards. Excellent communication skills in English, Hindi, and Telugu. Ability to work independently and collaboratively within a team environment. Proven ability to manage and supervise warehouse staff effectively.
We are looking for a meticulous Sr. Executive - Production to spearhead production activities and ensure adherence to stringent quality standards at Synnat Pharma Private Limited. As Sr. Executive - Production, you will play a pivotal role in managing batch manufacturing records, equipment compatibility, and various validation protocols, including process, cleaning, blending, drying, and micronization. The ideal candidate will be adept at preparing master formula records, quality equivalence reports, and standard operating procedures, while also taking the initiative for change controls and performance qualifications. This role demands a strong understanding of QMS activities, internal and external audits, and the ability to prepare comprehensive technical documentation. Coordinating with internal and external stakeholders, managing shift schedules, and ensuring regulatory compliance are also key aspects of this position. Your expertise in API manufacturing and commitment to cGMP will be essential in maintaining our high standards. You will contribute significantly to our mission of achieving global leadership in API manufacturing. Responsibilities: 1. Prepare, review, and maintain Batch Manufacturing Records (BMRs) and Master Formula Records (MFRs) in compliance with cGMP. 2. Develop and update Standard Operating Procedures (SOPs) and ensure accuracy of technical documentation. 3. Generate quality equivalence reports and other documentation required for audits and regulatory compliance. 4. Lead validation activities, including process, cleaning, blending, drying, and micronization protocols. 5. Conduct equipment compatibility studies and prepare performance qualification (PQ) documentation. 6. Analyze validation data, implement corrective actions, and ensure reliability of manufacturing processes. 7. Manage QMS activities, change controls, and impact assessments to maintain compliance. 8. Coordinate and participate in internal and external audits, addressing findings and implementing CAPA. 9. Collaborate with cross-functional teams including QA, Engineering, and Maintenance to ensure smooth production operations. 10. Prepare shift schedules, ensure adequate staffing, and oversee department-specific training programs. 11. Communicate effectively with stakeholders to resolve production issues and ensure adherence to safety and cGMP. 12. Drive continuous improvement initiatives to enhance production efficiency, compliance, and overall quality. General Expectations and Past Experiences: Strong expertise in API manufacturing processes and cGMP regulations. Experience in preparing BMRs, MFRs, SOPs, and technical documentation. Proven knowledge of validation activities (process, cleaning, equipment, etc.). Hands-on experience in QMS, CAPA, change control, and audit compliance. Excellent communication, coordination, and training skills. Ability to mentor staff and ensure adherence to safety and quality protocols.
We are looking for a meticulous Asst. Manager Production to lead production activities at Synnat Pharma Private Limited, ensuring seamless API manufacturing operations and adherence to the highest quality standards. As Asst. Manager Production, you will play a pivotal role in overseeing daily production activities, monitoring validation batches, and ensuring compliance with cGMP guidelines. Your responsibilities will include the preparation and review of production-related documents, coordination with cross-functional teams, and active participation in internal and external audits. You will also be responsible for identifying and resolving operational gaps, managing deviations and Out-of-Specification (OOS) incidents, and implementing Corrective and Preventive Actions (CAPA). With a strong focus on process optimization and continuous improvement, you will contribute to enhancing production efficiency and maintaining a facility that is always audit-ready. Your expertise in QMS (Quality Management Systems) and experience with ERP systems (SAP) will be crucial in driving operational excellence and ensuring the delivery of high-quality pharmaceutical products. Responsibilities: Oversee daily API production activities, ensuring compliance with established procedures and cGMP guidelines. Monitor validation batches, process parameters, and Batch Manufacturing Records (BMR/MBMR) for accuracy. Verify online BMRs and ensure compliance with regulatory and documentation standards. Coordinate with utility, QC, Stores, and Engineering teams to support seamless production operations. Supervise movement of finished products, intermediates, and recover solvents as per protocols. Identify and resolve operational gaps at the floor level to improve efficiency. Manage deviations, Out-of-Specification (OOS) incidents, and implement CAPA measures effectively. Ensure compliance with QMS and audit requirements; participate in internal and external audits. Prepare, review, and maintain accurate production documents, including validation protocols and training records. Develop preventive maintenance schedules, monthly production plans, and calculate raw material requirements. Train and mentor team members on production processes, compliance, and quality standards. Report production activities, deviations, and audit compliance to management while driving process improvements. General Expectations and Past Experiences: Strong understanding of API Manufacturing processes and cGMP guidelines. Demonstrated experience in preparing and reviewing production-related documents, including BMRs, validation protocols, and SOPs. Proven ability to manage and resolve deviations and Out-of-Specification (OOS) incidents effectively. Proficiency in using ERP Systems (SAP) for production planning, inventory management, and data analysis. Experience in participating in and contributing to successful internal and external audits. Strong leadership and communication skills with the ability to train and mentor production staff. In-depth knowledge of Cleaning Validation procedures and QMS (Quality Management Systems).
We are looking for a meticulous Chemist Production to manage production documentation preparation and batch record review at Synnat Pharma Private Limited. As a key member of our API Manufacturing Unit, you will play a crucial role in ensuring seamless production processes and adherence to the highest quality standards. Your responsibilities will include verifying daily logbooks, reviewing online Batch Manufacturing Records, and managing all production-related documents, including Process Deviation Control Orders (PDCOs). You will also be responsible for raw material indenting, updating activities in our ERP system, and participating in preventive maintenance programs. This role requires close coordination with the Shift In-charge and other departments to effectively follow production plans and maintain cGMP compliance. You will contribute to both internal and external audits, ensuring our operations meet regulatory requirements. Your expertise will be vital in maintaining the integrity of our manufacturing processes and supporting our commitment to quality and efficiency. If you are passionate about pharmaceutical production and thrive in a collaborative environment, we encourage you to apply. Responsibilities: 1. Create and prepare documentation for production operations with proficiency in MS Word and Excel. 2. Conduct thorough batch record reviews (BMRs, PDCOs, cleaning records) to ensure accuracy, completeness, and compliance with cGMP. 3. Prepare, update, and maintain production-related documents and SOPs, ensuring traceability and audit readiness. 4. Collaborate with QA to resolve discrepancies or deviations and implement corrective actions. 5. Coordinate with the Shift In-charge to execute production plans and meet timelines. 6. Indent raw materials, track consumption, and maintain accurate ERP entries for production activities. 7. Monitor inventory levels, report shortages, and support dispatch documentation after batch completion. 8. Support internal and external audits by providing required records and ensuring compliance with regulatory standards. 9. Investigate process deviations, prepare reports, and assist in implementing CAPA. 10. Participate in preventive maintenance scheduling and maintain equipment calibration/maintenance records. 11. Coordinate with maintenance teams to address equipment malfunctions and ensure readiness. 12. Conduct self-inspections of production areas to identify compliance gaps and propose improvements. 13. Ensure safety, adherence to cGMP practices, and continuous improvement in production operations. General Expectations and Past Experiences: Experience in API manufacturing with focus on batch record review and documentation preperation accuracy. Strong understanding of cGMP, PDCOs, and production documentation practices. Proficiency in ERP production modules for material management and tracking. Familiarity with preventive maintenance coordination and equipment validation. Experience in supporting audits and implementing CAPA. Strong analytical skills, attention to detail, and cross-functional collaboration.
We are seeking a detail-oriented Deputy Manager Quality Assurance to support robust QA operations and also some Regulatory Affairs functions at Acharya Group's API manufacturing unit. This role focuses on maintaining our Quality Management System (QMS) for API production, ensuring cGMP and regulatory compliance for EU, USFDA, PMDA, and other Major Regulatory Regions. Key responsibilities include participating in batch release and continuous improvement; overseeing validation of API manufacturing processes, equipment, and analytical methods, managing deviations, conducting investigations, and implementing CAPA plans. Candidates must have prior experience in Quality Assurance within API manufacturing , preferably at the level of Assistant Manager or Senior Executive , and demonstrate a proactive approach with a strong commitment to quality and compliance. Responsibilities: Lead QMS planning and implementation to ensure regulatory compliance and adherence to Acharya Group standards. Review and approve SOPs for Quality Management Systems, ensuring clarity and best practices in API manufacturing. Oversee document control for SOPs and BPCRs, maintaining accurate records. Train plant employees on quality procedures specific to API production. Review annual trending of products and intermediates to verify process and quality system consistency. Assist in implementing cGMP guidelines across the Acharya Group. Conduct validations (Process, Analytical Method, Cleaning) as per the Validation Master Plan for robust API manufacturing. Establish and maintain equipment calibration and validation procedures. Conduct vendor and internal audits to assess compliance and identify areas for improvement in the API supply chain. Ensure thorough investigation, resolution, and documentation of critical deviations, implementing effective CAPA measures. Conduct vendor and internal audits to assess compliance and identify opportunities for improvement within the API supply chain. Manage material and vendor quality, including handling audits by USFDA, EDQM, and customer audits. Review batch production and laboratory control records before releasing APIs and intermediates. Perform periodic product quality reviews and conduct quality risk analysis for continuous improvement of API manufacturing. General Expectations and Past Experiences: Possess a strong understanding of cGMP regulations and guidelines related to API manufacturing. Demonstrated experience in managing and leading quality assurance activities in a pharmaceutical setting. Proven ability to conduct and manage process validation, analytical method validation, and cleaning validation. Experience in preparing and reviewing regulatory documents such as DMF/ASMF. Proficient in using Quality Risk Management (QRM) tools and techniques. Excellent technical writing and documentation skills. Strong leadership and communication skills, with the ability to effectively interact with cross-functional teams and regulatory agencies.