8 Cgmp Compliance Jobs

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 laboratory. Verification of Specifications/standard test Procedures/Worksheets/Analytical Reports before Approval. Verification and review of the audit trails for Standalone, Empower and LIMS. Ensure cGMP / cGLP compliance. To follow Safety, Health and Environmental procedures and practices. Review and approval of excel sheet validations. Review results acceptance for API and Excipients and Packing material. Review of compiled of Stability Data and its verification/ Exhibit batch sampling protocols. Handling of Robotic Process Automation of Chromatography Data review (RPACD) To carry any other activities assigned by upward reporting staff. Qualifications Educational qualification: A Bachelor's/Master's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field Minimum work experience : 3 to 7 years of experience in pharmaceutical manufacturing or a similar role

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 in compression. Qualifications Diploma/ B.Sc./M.Sc.

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 additional materials as per approved requests. In the warehouse, you will be involved in tasks such as preparing goods receipt notes, generating material detail labels through SAP, and conducting stock transfers to other plants. You will also be responsible for periodic stock verification, reviewing daily balance verification, and maintaining proper storage and segregation of materials. Furthermore, you will need to handle tasks related to damaged or expired materials, coordinate with quality control and assurance departments, and ensure the cleanliness and housekeeping of the warehouse. You will also be involved in dispatching finished goods, reconciling stock with SAP, monitoring daily temperatures, and initiating change controls or deviations when necessary. Training subordinate staff, interacting with auditors, preparing SOPs, and handling various documentation tasks will also be part of your responsibilities. You may be assigned additional duties by the department head as needed and will need to maintain accurate records, perform SAP transactions, and ensure compliance with all relevant procedures. If you have any queries or need further clarification, please feel free to reach out to dipak.panchasara@zyduslife.com.,

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 managerial skills, a solid understanding of compliance requirements, and experience in warehouse management. You should be capable of handling legal aspects related to warehouse operations and have a background in manufacturing. This position offers the opportunity to take on a challenging role in a dynamic environment where you will play a crucial part in ensuring operational efficiency and regulatory compliance.,

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 Senior Engineer. In this role, you will be accountable for executing shift maintenance activities, including managing available resources to achieve maintenance targets, analyzing breakdowns, diagnosing faults, and supervising equipment repairs. You will also be involved in executing a comprehensive maintenance plan, preventive maintenance, calibration, and condition monitoring activities, ensuring adherence to standards and documenting all related activities. Handling breakdown maintenance to prevent recurrence, operating equipment efficiently as per SOP, implementing new technologies to improve machine performance, managing spares, adhering to EHS compliance, and ensuring cGMP compliance are also key aspects of the role. Moreover, you will be required to provide suggestions for process optimization, continuous improvements, and self-development in mechanical engineering and leadership aspects. Major challenges include adherence to budget constraints, cost vs. performance trade-offs, aging assets leading to escalating costs, and ensuring personnel and service providers" capability and competence. You will interact internally with Central Engineering, EHS, Site and Unit heads, and externally with OEMs, maintenance contractors, industry bodies, and statutory bodies. The role requires a BE/BTech in Mechanical Engineering with 2-5 years of experience in manufacturing, maintenance, and projects. You should have a deep understanding of manufacturing processes, organizational skills, technical knowledge of Pharma/API machinery, experience in project execution, knowledge of GMP and regulatory requirements, and leadership skills in mechanical engineering activities.,

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, Instrumentation & Microbiology. Analyze quality control test results and provide feedback and interpretation to production management or staff. Conduct regular inspections and tests on incoming raw materials, in-process production, and finished products. Monitor and analyze quality performance, identifying trends and areas for improvement. Investigate and resolve customer complaints related to product quality. Be responsible for defining operational strategy and road map for Quality Assurance management at the site. Execute site Quality Assurance goals and strategy in line with Sun Pharma compliance, product quality management objectives, and regulatory requirements. Effectively manage the site Quality Assurance activities and resources necessary to smoothly run the QA operation at the site. Be responsible for batch disposition of the products. Provide strong leadership and expertise to ensure the achievement of all Quality Assurance goals - business and functional at the site. Identify and implement solutions for improving existing site Quality Assurance systems and processes. Coach and develop both direct and, as appropriate, indirect reports through ongoing, example-based performance feedback, annual performance reviews, and the provision of training and development opportunities. This is a full-time job with a day shift schedule and requires in-person work location.,

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-routine analysis using HPLC, UPLC, GC, UV, IR, dissolution apparatus, and other analytical instruments. Ensure timely qualification/calibration of instruments used in AMV lab. Review analytical documents like raw data, chromatograms, validation reports, SOPs, etc. Support regulatory inspections (USFDA, EU, ANVISA, WHO, etc.) and respond to queries related to AMV/AMT. Investigate OOS/OOT/Deviation/Incident related to AMV activities and provide effective CAPA. Maintain GLP and cGMP compliance across AMV operations. Experience: 4 -5 years in QC-AMV in a regulated pharmaceutical environment Qualifications M.Sc. (Chemistry/Analytical Chemistry) / M.Pharm

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. This role demands a proactive individual adept at troubleshooting technical challenges, participating in scale-up batches, and driving continuous improvement initiatives. If you are passionate about optimizing pharmaceutical manufacturing processes, possess a strong understanding of QbD principles, and thrive in a collaborative environment, we encourage you to bring your expertise to Evertogen and contribute to our mission of delivering high-quality, affordable medications to the global market. Your contributions will directly impact our ability to meet client needs and maintain a diverse product portfolio. Job Details: Industry : OSD Formulation (Pharmaceuticals) Department : Technical Transfer Role : Assistant Manager Tech Transfer Location : Jadcherla Compensation : Up to 15 LPA Experience : 8+ years Employment Type : Full-time Qualification : M.Pharm / B.Pharm / M.Sc. in Pharma or related field Responsibilities: Technology Transfer Execution & Documentation: Lead technology transfer projects for solid dosage forms, ensuring adherence to timelines and quality standards. Develop technology transfer protocols covering critical process parameters and quality attributes. Oversee preparation and review of essential documentation (Technology Transfer Plans, Gap Analysis Reports, Process Flow Diagrams, BMR, BPR, Process Validation Reports). Coordinate cross-functional activities (R&D, Manufacturing, QA, RA) for seamless transfer and scale-up. Monitor process performance, addressing deviations or challenges. Maintain detailed records of technology transfer activities, ensuring compliance and data integrity. Ensure documentation adheres to cGMP, regulatory requirements (US FDA, EU EMA), and internal standards. Manage document archival and retrieval. Process Validation & Scale-Up: Participate in process validation activities for robust manufacturing processes of OSD Formulations. Analyze process data to identify CPPs and CQAs for process control strategies. Troubleshoot technical issues during scale-up and validation, implementing corrective actions. Evaluate the impact of process changes on product quality. Collaborate with engineering and production to optimize manufacturing processes. Ensure compliance with validation lifecycle management. Quality & Regulatory Compliance: Ensure compliance with cGMP, regulatory requirements (US FDA, EU EMA), and internal standards. Conduct risk assessments and implement mitigation strategies. Participate in audits, addressing findings and implementing corrective actions. Maintain understanding of regulatory requirements and best practices in OSD Formulation. Oversee CAPA implementation. Promote a culture of quality and compliance. Technical Troubleshooting & Continuous Improvement: Lead troubleshooting during initial commercial batches, identifying root causes and solutions. Apply problem-solving methodologies to address technical challenges in OSD Formulation. Identify process improvement opportunities. Utilize SPC tools to monitor process performance. Implement Lean Six Sigma principles. Champion continuous improvement. Cross-Functional Collaboration & Stakeholder Management: Coordinate with QA, QC, RA, and Production teams. Facilitate communication and collaboration among teams. Manage stakeholder expectations. Build relationships with internal and external partners. Generate progress reports, highlighting milestones, challenges, and risks. Present technical data to teams and management. Lead meetings to discuss project status and make decisions. Act as a liaison between R&D, Manufacturing, and stakeholders. General Expectations and Past Experiences: Possess 8+ years of hands-on experience in technology transfer within OSD manufacturing, demonstrating a strong understanding of the entire process lifecycle. Demonstrate proficiency in preparing and reviewing critical technical documents such as technology transfer protocols, BMR/BPR, and process validation reports. Exhibit a thorough understanding of Quality by Design (QbD) principles and their application in pharmaceutical manufacturing. Showcase strong technical troubleshooting skills with the ability to identify and resolve issues during scale-up and commercial manufacturing. Proven ability to coordinate and collaborate effectively with cross-functional teams, including QA, QC, RA, and Production. Demonstrate a solid understanding of regulatory guidelines (US FDA, EU EMA) and CGMP compliance requirements for pharmaceutical manufacturing. Experience risk assessment methodologies and CAPA management systems in a pharmaceutical setting.