19 Cgmp Guidelines Jobs

As a Sr. Executive in the Upstream Manufacturing Department located in BENGALURU, INDIA, your role involves overseeing various key responsibilities in Mammalian Cell Culture Upstream Processing within the Manufacturing Department. Your qualifications should include a BTech/MTech/MSc degree along with 6-8 years of relevant experience. Role Overview: - Manage vial thaw, cell counting, and seed expansion activities. - Oversee media preparation, wave bioreactor, and SS bioreactor operations. - Maintain documentation such as Batch Manufacturing Records/Special Process Requirements. - Ensure compliance with Quality Management Systems by handling deviations, change controls, risk assessment documen...

Job Responsibilities: Supervise and coordinate the activities of the filling line team, including operators, technicians, and other personnel. Ensure the efficient and compliant operation of vial washing, depyrogenation tunnel, and filling machines (Groninger and BOSCH). Enforce adherence to cGMP guidelines, national regulations (Schedule M), and international standards (WHO) across all filling operations. Oversee the training and development of filling line personnel on aseptic techniques, equipment operation, and documentation practices. Monitor and evaluate the performance of team members, providing regular feedback and conducting performance reviews. Create and maintain staff schedules t...

As a Biopharmaceutical Manufacturing Specialist, you will be responsible for hands-on execution of manufacturing processes in both upstream and downstream operations. This includes working with single-use bioreactors, media preparation systems, AKTA systems, chromatography columns, UF/DF systems, buffer preparation units, virus filtration, and other single-use technologies. Your main focus will be to ensure batch operations are conducted in compliance with cGMP guidelines, maintaining strict adherence to quality standards and regulatory requirements. Key Responsibilities: - Conduct batch operations in compliance with cGMP guidelines - Maintain and support Quality Management Systems activitie...

Job Description: As an Operator - Packaging at Dishman Carbogen Amcis Limited in Bavla, Gujarat, your main role will involve operating and troubleshooting bottle filling, capping, retorque, and checkweigher machines. You will also be responsible for maintaining online documentation entries including daily logs, Batch Production Records (BPR), and weighing balance calibration records. It is crucial to have knowledge of Good Documentation Practice in accordance with current Good Manufacturing Practice (cGMP) guidelines. Collaboration with various teams such as manufacturing, warehouse, engineering, quality control (QC), and quality assurance (QA) to meet daily packing targets is essential. Fur...

As a Senior Principal Engineer (Civil) located in Gurgaon, your responsibilities will include: - **Design & Engineering Leadership**: - Lead civil and structural engineering design for pharma/biotech projects such as R&D labs, cleanrooms, manufacturing plants, utility buildings, and warehouses. - Ensure that designs comply with cGMP, FDA, EMA, and local building codes. - Supervise the preparation and review of civil/structural drawings, calculations, and specifications. - **Project Management**: - Oversee multiple projects from concept to detailed design, construction, and handover. - Coordinate with various teams like Architectural, MEP, Process, Safety, and Validation. - Monitor project sc...

Role Overview: You will be responsible for performing the microbial analysis of various water samples, raw materials, packaging materials, and finished products. This includes carrying out analysis of microbiology stability samples and market complaint samples. Additionally, you will participate in Analytical method transfers, equipment cleaning validation, and process validations to ensure quality control. Key Responsibilities: - Following QC SOPs and procedures in strict adherence to cGMP - Adhering to systems and procedures (SOPs) for conducting QC functions as per requirements - Ensuring that all equipment and instruments are in a validated and calibrated state - Maintaining media/cultur...

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world's most complex challenges and deliver more impact together. Role description: This role plays a vital role within Arcadis's Global Excellence Centre (GEC), a cohesive and diverse project delivery group consisting of over 3,000 skilled professionals stationed across offices in India, Romania, and the Philippines. Operating in conjunction with our global bu...

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world's most complex challenges and deliver more impact together. Role description: This role plays a vital role within Arcadis's Global Excellence Centre (GEC), a cohesive and diverse project delivery group consisting of over 3,000 skilled professionals stationed across offices in India, Romania, and the Philippines. Operating in conjunction with our global bu...

As a Plant Engineer, you will be responsible for overseeing plant engineering activities related to both process and utilities. Your primary focus will be to ensure that the plant always remains cGMP compliant in terms of engineering aspects and safety standards. You should have hands-on experience in operational excellence to streamline plant operations efficiently. Key Responsibilities: - Manage a team of 80 people to effectively carry out engineering tasks - Preferably have experience in facing regulatory audits from USFDA and EU - Worked in injectable manufacturing sites to understand the specific requirements and challenges in this sector Qualifications Required: - Bachelor's degree in ...

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world's most complex challenges and deliver more impact together. Role description: This role plays a vital role within Arcadis's Global Excellence Centre (GEC), a cohesive and diverse project delivery group consisting of over 3,000 skilled professionals stationed across offices in India, Romania, and the Philippines. Operating in conjunction with our global bu...

Job Description: As a Maintenance Technician, you will be responsible for undertaking preventive maintenance of all utility equipment and efficiently diagnosing and rectifying breakdowns to minimize downtime and support operations. You will also ensure compliance with safety standards, GMP norms, and statutory electrical regulations. In addition, you will coordinate with cross-functional teams for the timely execution of maintenance schedules and shutdowns. Keeping accurate records of maintenance logs, calibration data, and electrical inventory will be a crucial part of your role. Moreover, you will support energy optimization initiatives and contribute to continuous improvement in utility p...

Role - API Project Management Role (for R&D / Peptide - Pharma Business) Job Location - Based at Bangalore Should be in Pharma industry preferably in API project/program mgmt. Responsibilit ies:- Ensure project/program GOALs/targets are achieved in desired time. Should be able to complete the project within the constraints of project triangle. Should be able to interact and get all the cross functional team members together and come to common consensus as per the project requirements to achieve the project deliverables. To ensure project timelines in line with the business objectives (Cost, Time, Quality). Collaborate with various stakeholders like R&D/Regulatory/ Clinical/IPR/Analytical R&D...

Role Overview: As an IPQA Executive at Syngene International Limited in Bengaluru, you will play a crucial role in the GMP IPQA team. Your primary responsibility will be to provide independent assurance to the quality of various stages of the process, ensuring the integrity of the process by overseeing equipment cleaning before and after processes and providing line clearance for different process steps. Your role will focus on ensuring process quality and the final product's manufacturing without any quality concerns post-process completion. Key Responsibilities: - Prepare, revise, and review procedures such as SOPs, protocols, reports, calibration schedules, and other related documents. - ...

Role - API Project Management Role (for R&D / Peptide - Pharma Business) Job Location - Based at Bangalore Should be in Pharma industry preferably in API project/program mgmt. Responsibilit ies:- Ensure project/program GOALs/targets are achieved in desired time. Should be able to complete the project within the constraints of project triangle. Should be able to interact and get all the cross functional team members together and come to common consensus as per the project requirements to achieve the project deliverables. To ensure project timelines in line with the business objectives (Cost, Time, Quality). Collaborate with various stakeholders like R&D/Regulatory/ Clinical/IPR/Analytical R&D...

The role in Pharma Solution's Quality Control department based in Lexington requires you to perform complex testing of raw materials, in-process and finished products while ensuring the calibration and maintenance of analytical instruments in compliance with cGMP standards. This night shift position directly reports to the AQC Group Lead. Your key responsibilities will include conducting routine/non-routine testing using wet chemistry and instrumental analysis methods, testing various samples such as raw materials, APIs, finished products, stability samples, and cleaning verification samples. Proficiency in HPLC/GC analysis is essential along with documenting laboratory work following GDP, c...

As a Senior Executive in the Upstream Manufacturing Department located in Bengaluru, India, you will be responsible for various tasks related to Mammalian Cell Culture Upstream Processing. With a required educational qualification of BTech/MTech/MSc and 6-8 years of relevant experience, you will play a crucial role in the manufacturing operations. Your primary responsibilities will include managing vial thaw, cell counting, and seed expansion activities. Additionally, you will oversee media preparation, wave bioreactor, and SS bioreactor operations. It will be your duty to ensure proper documentation practices are followed, including maintaining Batch Manufacturing Records and Special Proces...

As a Quality Control Manager in the pharmaceutical industry, your primary responsibility will be to plan and execute Quality Control (QC) activities in a timely manner. You will need to ensure adherence to quality and safety norms, assess and organize required resources, and demonstrate good communication skills. Your role will be crucial in upholding cGMP guidelines and FDA standards. To excel in this position, you should possess excellent organization, time management, and leadership skills. A deep understanding of Bulk drugs and intermediates quality control processes and systems will be essential. You must also have comprehensive knowledge of quality control management, risk management, ...

Company Description GLOBELA PHARMA PVT LTD, located in Bharuch district, is an ISO 9001:2015, WHO cGMP accredited pharmaceutical manufacturing company. We specialize in producing high-quality pharmaceutical formulations in various forms such as tablets, capsules, and dry powder ORS. Our products are registered in multiple overseas countries, including Bolivia, Costa Rica, Panama, Venezuela, and Kenya, among others. We have dedicated facilities for contract manufacturing, party-to-party manufacturing, and loan license manufacturing. Role Description This is a full-time on-site role as a Production Manager at GLOBELA PHARMA PVT LTD in Bharuch district. The Production Manager will be responsibl...

Role & responsibilities Job Responsibilities/Descriptions 1.0 Knowledge on Guidelines (ISPE, PDA, ICH) regulation (FDA & EMA). 2.0 Participate in Equipment, Area, Utilities and Facility qualifications. 3.0 Preparation and Review of URS, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Commissioning Studies, and SOPs related to Equipment/systems. 4.0 To monitor the Performance Qualification of various equipment and systems at site. 5.0 Review of Performance Verification protocols and reports. 6.0 To be part of process validations studies like Washing Validations, Mixing Validations, CIP and SIP validations, Filling Validations, Capping Va...