20 Cgmp Compliance Jobs

As a Material Management Specialist, your role involves planning and controlling inventories of raw materials and packaging materials to meet production requirements. You will coordinate with Purchase and Quality Control teams to ensure timely availability and release of materials. Additionally, you will oversee the receipt, storage, and dispensing of materials in compliance with SOPs, MSDS, and safety requirements. It will be your responsibility to manage the return, rejection, and destruction of non-conforming materials following established procedures. Your key responsibilities include: - Planning and controlling inventories of raw materials and packaging materials - Coordinating with Pur...

As a responsible team member in the pharmaceutical manufacturing process, your role involves the following key responsibilities: - Conduct line clearance activities before starting various operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. - Perform process validation, cleaning validation/verification, hold time study, media fill, and routine batch sampling according to protocol/SOP. - Review executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs). - Perform in-process tests at different stages as per batch documents/SOP. - Review environmental monitoring and water trends. - Review different types of calibration certifica...

Execute day-to-day production activities as per production plan. Operate and monitor production equipment (Granulation, Compression, Coating, Packing, etc. based on plant). Ensure adherence to cGMP, SOPs, and regulatory guidelines during all production activities. Maintain batch manufacturing records (BMRs), logbooks, and online documentation. Coordinate with QA, QC, Maintenance, and Warehouse for smooth operations. Implement safety, quality, and housekeeping standards within the production area. Support investigations (deviations, OOS, incidents) and assist in CAPA implementation. Train new operators / apprentices on processes and equipment. Participate in qualification/validation activitie...

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 clo...

Develops and maintains a Quality Assurance Agreement in cooperation with the external partners. Responsible for the initial qualification and onboarding of contract manufacturers as well as for performing regular quality risk assessments. Ensures that all aspects of manufacturing, testing, release and distribution of drug substance/drug product/ intermediate product/material are in compliance with applicable ADACAP and Novartis standards, the effective Quality Assurance Agreement, relevant guidelines and the Quality Management System of the external partners. Manages and oversees contract manufacturer s activities related to quality processes such as deviations, complaints, recalls, counterf...

The role involves ensuring CGMP compliance and supervising overall production activities of the manufacturing area of multiple assigned manufacturing lines. Additionally, the position requires reviewing and maintaining online documents. You will be responsible for the preparation, review, revision, control, and implementation of standard operating procedures. You will also handle the preparation and review of master production documents, protocols, reports, and various document management tasks such as BMRs and BPRs. Your duties will include managing Change Control, Deviations, CAPA, Investigations, and ensuring line clearance activities are conducted before operations like manufacturing, fi...

You will be part of the Documentation team in the Production Department at Sai Life Sciences located in Bidar. As a leading Contract Research, Development, and Manufacturing Organization (CRDMO), we partner with numerous global innovator pharma and biotech companies to support the advancement of their NCE programs. With a workforce of over 3000 professionals in India, the UK, and the USA, we are dedicated to fostering scientific excellence and ensuring customer success. Our organization is characterized by a culture of openness, mutual respect, and inclusivity, and we are committed to diversity and equal opportunity practices at all levels. Your primary responsibilities will include drafting...

As the Head of Manufacturing API, you will be responsible for overseeing all API production activities at our Atchutapuram, Andhra Pradesh facility. With over 20 years of experience in API manufacturing, you will lead the team to ensure safe, compliant, and efficient manufacturing operations. Your role will involve achieving production targets, maintaining cGMP compliance, and driving continuous improvement across the API manufacturing units. Your key responsibilities will include: Production Management: - Planning and executing API manufacturing based on production schedules. - Ensuring adherence to batch production records (BMRs) and standard operating procedures (SOPs). - Optimizing proce...

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 com...

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 Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngenes 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. Syngene works with biotech companies pursuing leading edge science as well as multinationals. Job Summary We are seeking a seasoned engineering leader to step into the role of Head of Engin...

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. We are looking for a motivated individual to support cGMP compliance within procurement operations. In this role, you will assist with key compliance activities such as investigating deviations, supporting CAPAs, coordinating supplier audits, handling change controls, and...

Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical activities in Quality control laborato...

You will be responsible for overseeing execution of day-to-day production activities. You will be responsible for guiding and coaching employees, monitoring their productivity, and overseeing regular equipment safety and maintenance. You will be responsible for performing batch execution in OSD (Oral Solid Dosage) manufacturing You will be responsible for execution and review of Documentations, eBMR (Batch Manufacturing Records), You will be responsible for ensuring product quality by maintaining cGMP (current Good Manufacturing Practices). You will be responsible for handling Compressionactivities. You will be responsible for in process checks in compression and execute end to end activity ...

You will be working in the Store & Warehouse department as an Assistant Manager, reporting to the Department Head. Your main responsibilities will include dispensing raw materials according to standard operating procedures, ensuring compliance with cGMP regulations, and maintaining cleanliness and sanitation in the raw material dispensing area. You will be required to perform daily verification of weighing balances, record temperature and humidity levels, and ensure the proper cleaning and operation of equipment such as vacuum cleaners and barcode scanners. Additionally, you will be responsible for calibration of balances, segregation of dispensed materials for different batches, and issuing...

As Deputy Manager - Stores at Dishman Carbogen Amcis Limited located in Bavla, Gujarat, IN, you will be responsible for overseeing various key activities. Your role will involve managing Quality Management System (QMS) activities, ensuring compliance with Current Good Manufacturing Practices (CGMP), handling regulatory and customer audits, and overseeing the formulation warehouse operations independently. Additionally, you will be tasked with managing all activities of the Raw Material (RM) warehouse, including receipt, storage, and dispensing, as well as overseeing finished goods and dispatches for both domestic and export purposes. The ideal candidate for this role should possess strong ma...

The job involves being a team member of the Engineering Maintenance & Reliability Team within the Active Pharmaceutical Ingredient department of the Manufacturing division. Your primary responsibility is to execute maintenance activities in the plant, ensuring minimal breakdowns and maximum efficiency while adhering to safety and GMP standards. You will support the Senior Engineer in planning, scheduling, and executing maintenance activities to ensure plant and equipment availability, capacity, integrity, and reliability as per company policies and procedures. Additionally, you will be responsible for maintenance tasks in the Manufacturing, Packing, and utility areas as assigned by the Senio...

You should be a candidate from the Pharma Industry to: Design, implement, and manage quality control systems to ensure products meet established standards and specifications. Develop and maintain quality control procedures and documentation. Establish and enforce quality control and compliance standards across all departments. Manage Functions of Quality Control Systems, CGMP compliance, and Validations. Analyze Raw Materials & Finished Products. Manage the laboratory teams and determine work priorities. Daily plan analysis and ensure the analysis of raw materials, intermediates, and in-process controls. Have control over day-to-day activities of the QC Dept with Chemical Laboratory, Instrum...

Job Overview To lead and execute analytical method validation, transfer, and verification activities in compliance with regulatory and cGMP standards, ensuring robust analytical support for product development, regulatory submissions, and commercial manufacturing. Competencies Plan, perform, and document Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) for raw materials, intermediates, and finished drug products. Prepare and review protocols and reports related to method validation/verification/transfer in alignment with ICH guidelines. Coordinate with R&D, AR&D, QA, RA, and manufacturing units for method transfer and troubleshooting activities. Perform routine and non...

We are looking for a meticulous and experienced Technology Transfer Manager to spearhead the efficient transfer of technology for solid dosage forms at Evertogen Life Sciences . This pivotal role involves overseeing the seamless transition of OSD products from R&D or third-party development to our manufacturing plant, ensuring successful scale-up, unwavering regulatory compliance, and adherence to the highest quality standards. The ideal candidate will champion the preparation and review of critical technical documents, including technology transfer protocols, BMR/BPR, and process validation reports, while actively coordinating with cross-functional teams such as QA, QC, RA, and Production. ...