9 Cgmp Guidelines Jobs

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...