27 Cgmp Guidelines Jobs

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Cytiva, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological re...

As a Senior Principal Engineer (Civil) located in Gurgaon, your role will involve the following responsibilities: 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 pro...

As a Quality Assurance Officer at our company, you will play a crucial role in ensuring the quality and compliance of our API manufacturing activities with cGMP guidelines and regulatory standards. Your responsibilities will include: - Overseeing documentation, audits, and compliance processes to ensure all API manufacturing activities meet cGMP, regulatory, and quality standards. - Familiarity with cGMP guidelines and proficiency in using Word and Excel. - Monitoring and maintaining quality assurance systems to ensure product quality and compliance. You should have 1-2 years of experience in Bulk Drugs in the Quality Assurance department. The ideal candidate will hold a degree in M.Sc./B. S...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Cytiva, one of 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research ...

As a Manager at Sun Pharma Laboratories Ltd in Guwahati - Operations OSD, your role will involve the following responsibilities: Role Overview: You will be responsible for monitoring and maintaining documentation related to QMS activities, including SOPs, change controls, deviations, and CAPAs. Additionally, you will handle market complaints by conducting root cause analysis and implementing corrective actions. Your role will also require ensuring implementation and compliance with Quality Management System (QMS) guidelines and facilitating training programs for personnel on QMS procedures, regulatory requirements, and best practices. Compliance with Good Manufacturing Practices (GMP) and co...

As a holder of the position, your key responsibilities will include: - Initiating Change Control and performing impact assessments. - Conducting manufacturing investigations related to deviations, OOS, OOT, and market complaints to identify root causes and implement appropriate CAPAs. - Ensuring compliance with quality notifications such as deviations and investigations for proper closure. Reviewing non-conformances, deviations, change controls, internal audits, annual product quality reviews, and assessing other impacting documents and related activities. - Handling Track-wise software, SAP, and Document compliance software. - Performing and participating in Quality risk management exercise...

As an API Regulatory Affairs Manager, your role involves ensuring that API regulatory activities are carried out according to the specified time schedule and ensuring timely readiness of API regulatory documents/DMFs for new submissions/updates. You will be required to provide necessary regulatory support, advice, and guidance to the concerned API manufacturing sites and R&T Unit. Additionally, you will need to assure the quality of DMF submissions and maintenance, taking into consideration the company's Intermediates business. Your responsibilities also include providing technical inputs to Section Heads for APIs and Key for regulatory adequacy. Key Responsibilities: - Co-ordinate and colla...

You should have experience working in a Managerial capacity in Pharmaceutical API Intermediate/CDMO manufacturing set ups. Your responsibilities will include: - Managing daily production activities according to the monthly plan - Improving and monitoring yield and quality - Ensuring raw material planning in coordination with the Stores Department - Monitoring and reducing production cycle time - Preparing monthly reconciliation reports - Effectively managing available resources and manpower - Ensuring all processes are carried out in accordance with cGMP guidelines in coordination with the Quality Assurance Department - Reviewing filled Batch Production Records (BPR) after batch completion -...

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, ...