4 Cgmp Guidelines Jobs

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 Process Requirements. Furthermore, you will be accountable for the documentation of Quality Management Systems, such as deviations, change controls, and risk assessment documents. Your role will also involve managing facility maintenance in compliance with cGMP guidelines to ensure operational efficiency and adherence to quality standards. Overall, as a Senior Executive in the Upstream Manufacturing Department, you will play a critical role in ensuring the smooth functioning of manufacturing processes and maintaining high-quality standards in all operations.,

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, and safety regulations, along with a strong grasp of GMP principles and OH&S requirements. Your proficiency in documentation and audit requirements will be key to maintaining quality standards. Effective communication skills and the ability to build strong working relationships across the organization are essential. You should be confident, possess good decision-making abilities with attention to detail, and be well-versed in computer applications such as Word, Excel, PowerPoint, and Thunderbird. As a team player, you are expected to be proactive, focused, disciplined, and well-mannered. Being open to taking on additional responsibilities and demonstrating enthusiasm to work in a dynamic environment will be beneficial. Clear and concise communication is crucial for success in this role. Compliance with FDA approval and having prior experience in Quality Control as a Manager, Deputy Manager, or Assistant Manager are mandatory requirements for this position. The role is based in Solapur, Maharashtra, and requires a minimum of 10 years of total work experience. If you meet the specified criteria and are interested in this full-time, permanent position, kindly send your CV to vivekr@devichemscience.com.,

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 responsible for overseeing day-to-day manufacturing operations, ensuring compliance with quality standards, managing production schedules, coordinating with various departments, and optimizing production processes to meet production targets and deadlines. Qualifications Experience in pharmaceutical manufacturing or a related industry Knowledge of cGMP guidelines and quality management systems Strong leadership and team management skills Excellent problem-solving and decision-making abilities Good communication and interpersonal skills Attention to detail and ability to work under pressure Bachelor's degree in Pharmacy, Chemical Engineering, or a related field Prior experience as a Production Manager is a plus,

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 Validations, Autoclave, DHS Validations and providing support for preparation and review of summary report. 7.0 Review and verification of Calibration, Preventive Maintenance and Annual Maintenance records of equipments related to GMP Area. 8.0 Handling of Qualification related change controls, Deviation and CAPA initiation and closure. 9.0 Handling and knowledge on breakdowns, Notifications, and clearance request. 10.0 Basic knowledge on 21 CFT part 11 requirements. 11.0 Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. Identify and mitigate risks related to computerized systems at the site level. 12.0 Preparation and review of the SOPs related Qualification, validation (Including CSV) and review of Engineering SOP. 13.0 To ensure the Audit trails and data integrity compliance for GxP computerized systems. 14.0 Reviewing and approving (or rejecting) validation or qualification protocols and or reports. 15.0 Providing Quality oversight on engineering activities. Knowledge on Preventive maintenance and Calibration. Preferred candidate profile