9 Gmp Guidelines Jobs

As a Production Chemist at our WHO-GMP Pharma Factory, you will play a crucial role in overseeing the production processes of tablet medicines to ensure quality and efficiency in manufacturing. Your responsibilities will include managing manufacturing operations, maintaining quality control standards, optimizing processes, documenting production activities, ensuring equipment maintenance, adhering to safety protocols, and collaborating with the quality assurance and production teams for seamless operations. To qualify for this role, you should hold a Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related field, along with a minimum of 2 years of experience in a production chemist role within the pharmaceutical industry. You should have a strong understanding of GMP guidelines and quality assurance principles, proficiency in using production equipment, problem-solving skills, and excellent communication and teamwork abilities. Proficiency in Microsoft Office tools is also required. The ideal candidate for this position should be detail-oriented, organized, able to work under pressure, and meet deadlines consistently. You should be self-motivated, proactive in identifying improvements, and possess a collaborative spirit to work effectively with cross-functional teams. In return, we offer a competitive salary based on experience, opportunities for career growth and professional development within the company, ongoing training programs, health insurance coverage for you and your family, a friendly and supportive work environment, and the chance to work at our modern, WHO-GMP certified manufacturing plant. Additionally, you will enjoy perks such as flexible working hours, employee wellness programs, and rewards and recognition for outstanding performance. Join our team and be part of a dynamic environment where your contributions make a meaningful impact on the healthcare industry.,

As a Supply Chain Specialist for the Active Product Ingredient (API), Excipients, consumables, and component sourcing in the fast-growing clinical division, your main role involves identifying and agreeing upon the supply chain. You will be responsible for sourcing new products and suppliers, ensuring compliance with regulatory requirements and staying informed about market trends. Negotiating competitive prices is essential to support the business in achieving its targets and margins efficiently. Your responsibilities also include processing orders from other departments, managing the supply chain effectively, and maintaining a supplier base aligned with the company's commercial objectives. It is crucial to procure products at competitive prices with all necessary regulatory documentation and to source analytical and manufacturing equipment meeting specific requirements. Additionally, you will be involved in designing and distributing marketing materials, collaborating with the Business Development and Supply Chain teams for material requirements, and closely coordinating with the Project Management team across technical departments. Assisting in artwork design, branding, reviewing supplier or manufacturer contracts, and conducting cost price negotiations are part of your duties. Furthermore, you will support other buyers in their categories, train and assess new staff members, liaise with the finance department on pending invoice matters, and ensure adherence to Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP) guidelines. Accuracy in calculations and measurements, as well as the maintenance and updating of standard operating procedures, are integral to your role.,

Key Responsibilities : Technical Skills Candidate should have good understanding of Chemistry and biology pharma R&D lab. Candidate should have exposure of lab computing support in handling lab instruments needs. Candidate should have implementation experience of Electronic Lab notebooks (ELN) preferably Biovia or Perkin Elmer Candidate should be familiar with GMP guidelines. Experience in demonstrating a track record of delivering scientific solutions in the pharmaceutical and CRO industry. Experience in the implementation of Informatic applications like (Electronic Laboratory Notebooks(elNB), Laboratory Information Management System, Chromatography Data system (CDS) and other scientific applications. Experience in working with Data acquisition layer /Comprehensive Data Management /Data Lake/ Data Mart (Data Warehouse) and Scientific Data Management System (SDMS). Roles and Responsibilities Understand the informatics (ELN , CDS) needs of Labs and provide support of informatics Applications. Coordinate between scientists and vendor for any solution development. Implement new solutions/applications and provide support for existing scientific applications running at Sai. Facilitates computer system validation and ensures that scientific applications are always in validated state. Experience/Qualification: Demonstrated track record in delivering scientific solutions preferably in a pharmaceutical and biotechnology industry. Industry experience 4-5 years desired. Key Competencies (Technical, Functional & Behavioural): Strong analytical and communication skills (written and oral) required. Ability to work within an interdisciplinary research team. Candidate should have good understanding of project management. Show more Show less

As a Quality Assurance Officer at our organization, your primary responsibility will be to review and ensure compliance of Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and protocols across all our sites. You will also be required to conduct internal audits and provide support during external regulatory audits from bodies such as USFDA, WHO, MHRA, and others. Monitoring Corrective and Preventive Actions (CAPA) implementation and change controls will be part of your duties to ensure data integrity and Good Manufacturing Practice (GMP) compliance across our manufacturing units. You will also be responsible for evaluating product quality trends and preparing quality reports based on your findings. Collaborating with cross-functional teams to drive Quality Assurance (QA) improvements throughout the organization will be essential. Therefore, proficiency in GMP guidelines, documentation, audit handling, Quality Management Systems (QMS), and excellent communication skills are crucial for success in this role. The working location for this position is Rabale. The ideal candidate should hold a B.Pharm, M.Pharm, or M.Sc degree. This is a full-time role with benefits including paid sick time, paid time off, and Provident Fund contributions. We prefer candidates with a Bachelor's degree and at least 2 years of experience in a similar role. The work location will be in person, requiring your physical presence at our facilities. If you are passionate about ensuring quality compliance, driving continuous improvement, and working in a dynamic cross-functional environment, we encourage you to apply for this exciting opportunity.,

As a Sr. Executive / Asst Manager (Shift Incharge) in the Production Fermentation (Upstream) department at Natural Biogenex Pvt. Ltd., you will play a crucial role in overseeing and leading shift-wise operations effectively. With 6 to 10 years of experience and a background in M.Sc. / B.Tech. / B.Sc. in Biotechnology, Microbiology, or Industrial Microbiology, you will be responsible for ensuring the smooth functioning of fermentation processes in compliance with SOPs and production schedules. Your key responsibilities will include supervising and monitoring shift activities, ensuring operational efficiency, timely escalation of issues, maintaining documentation as per GMP standards, managing shift planning and manpower allocation, promoting a culture of safety-first practices, and assisting in data analysis for process improvement. Your strong technical knowledge of fermentation processes, effective team leadership skills, and sound decision-making abilities will be essential in driving optimal plant efficiency and adherence to regulatory standards. At Natural Biogenex Pvt. Ltd., you will have the opportunity to work in a modern biotech production environment, with structured career growth plans, exposure to advanced fermentation technologies, and a professional and inclusive work culture. Joining our team will allow you to be a part of a leading API manufacturing company with cutting-edge technology, global regulatory standards, and opportunities for professional development and competitive compensation.,

You are urgently required to join Lavanya Healthcare Limited as a Sachet Packing Machine Operator. Your responsibilities will include operating, cleaning, and performing minor maintenance on sachet packaging machines. It is essential that you have 1 to 2 years of experience in sachet packing or similar machine operation and possess a 10th or 12th pass education qualification. Your role will be in the Production / Packaging department, and you should be well-versed with GMP guidelines. The work schedule is Monday to Saturday from 9:00 AM to 6:00 PM. The job type is full-time, and the work location is in person at Near Phillanto Company, Behra Road, Dera Bassi, Punjab. In addition to a competitive salary, you will receive benefits such as health insurance, paid sick time, paid time off, and Provident Fund. Limited openings are available, so contact the HR at 90567 69033 to apply for an interview. Don't miss this opportunity! Apply Now before the application deadline on 20/08/2025.,

The Form-Fill-Seal (FFS) Operator position entails operating and maintaining Form-Fill-Seal machines utilized in the production of IV Fluids. Your primary responsibility will be to ensure the smooth and efficient operation of these machines, along with monitoring the production process to uphold high standards of quality and safety. You will be tasked with operating and monitoring the Form-Fill-Seal machines, making necessary adjustments, and conducting routine maintenance procedures as required. It is crucial to ensure the proper functioning of the machines, troubleshoot and address any issues that may arise during production, and maintain compliance with standard operating procedures (SOPs) and quality standards. Regular quality checks and inspections of finished products will be part of your responsibilities to guarantee they meet the specified requirements. Adherence to Good Manufacturing Practices (GMP) and safety guidelines is essential to uphold a clean and safe production environment. Accurate recording of production data, collaboration with team members and departments, and coordination of production activities are also key aspects of this role. The ideal candidate for this position should possess an ITI, diploma, or equivalent qualification, with technical training or certification in machine operation being preferred. A minimum of 2 years of experience operating FFS machines in an IV Fluids manufacturing environment is required. Knowledge of FFS machine operation, setup, and maintenance, along with an understanding of GMP guidelines and quality control standards, will be beneficial. Attention to detail, strong problem-solving skills, and the ability to perform quality checks and inspections accurately are essential qualities for this role. You should be capable of working independently as well as part of a team in a fast-paced production environment. Good communication skills, the ability to follow instructions and SOPs, and flexibility to work different shifts and overtime if needed are also necessary. The physical requirements of this role include the ability to stand for extended periods and perform repetitive tasks effectively.,

Trending Job Description Key responsibilities. Responsible for working with Technology Transfer, Production, and the Client to generate, revise, and approve master production records (MPRs) and any other documents associated with the commercial products in the manufacturing, e.g., SOPs, material specifications, technical reports, etc. Preparing unplanned and planned deviations for responsible processes and forming the investigation team. Collaborates with Process Development (PD), Technology Transfer (TT), Operations, Quality Control (QC), and Quality Assurance (QA) in problem-solving activities, including deviation writing and CAPA closure. Work with project and engineering teams to replace existing/modify or buy equipments for continuous improvement or capacity enhancement Functions as the technical interface between PPS-Riverview and the Client, focusing on providing technical advice and support, engineering solutions, overseeing GMP runs in the plant equipment, analyzing production data to evaluate process performance, and writing production summaries. Will require solid understanding of manufacturing processes, GMP guidelines, site and corporate policies and procedures, hands-on experience, and complete understanding of production processes in the GMP environment as laid out at PPS-Riverview. Willingness to work flexible hours and shifts when there is a need. Responsible for providing independent production support during off-hours as needed. Ability to travel as needed. Ensures process data is being updated on a monthly basis and analysis manufacturing KPI performance for improvement and discussion with the client. Takes part in Operational Excellence activities for the plant. KEY INTERACTIONS. Production Technology Transfer External Clients Project Management Education/Experience. Bachelors Degree in Chemistry or Engineering or a similar discipline is required with at least 0-3 years of relevant experience. Additional Masters or Ph.D. is preferred in lieu of some experience. Demonstrated project management and technical leadership capabilities. Confident management of internal and external stakeholder relationships. Good written and oral communication skills. Demonstrated teamwork skill and professionalism in all interactions. Proven track record of successful technology transfer. Working knowledge of process and desktop computers. COMPLIANCE. Compliance with 21 CFR - Parts 210/211, EU Directives 91/356/EEC and ICH Q7. Compliance with SOPs, batch records, forms, logs of use and Quality Agreements. Recognizes common sources of failure and improves documentation to reduce deviations and errors. Works with Operations Personnel to improve compliance. Ensures work is in compliance with all state and federal regulations, including but not limited to OSHA, GMP, DEA, FDA, etc. Assists in the formulation of corrective procedures when needed. Uses appropriate PPE while inside a manufacturing area. Assumes responsibility for safety and knows appropriate emergency procedures in case of emergency. Knows the location of SDS binders and understand how the guidelines pertain to employees. JOB CONDITIONS The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If any accommodations are needed, requests should be made to our Human Resources department. Physical Demands: Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected. Long periods of standing and walking can be expected in this position. This position may require long periods of sitting, typing, computer entry or looking at a computer. Work Environment: Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes. Potential limited exposure to hazardous chemicals. Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position. Job Info Job Identification 8173 Job Category Operations Posting Date 03/30/2025, 12:47 PM Job Schedule Full time Locations Ash Stevens LLC, Riverview, MI, 48193, US,

As a Project Manager in the pharmaceutical industry with a PhD (Doctor of Philosophy), your role involves overseeing and managing projects related to drug development, clinical trials, regulatory compliance, or other pharmaceutical initiatives Your advanced academic background in pharmaceutical sciences provides you with a deep understanding of the industry and scientific principles You develop project plans, timelines, and budgets, considering the specific objectives, deliverables, and resource requirements of pharmaceutical projects You coordinate with cross-functional teams and stakeholders to ensure effective project execution Risk Assessment and Management: You identify potential risks and challenges associated with the project and develop risk management strategies to mitigate them This includes monitoring and evaluating risks throughout the project lifecycle and implementing contingency plans when necessary Regulatory Compliance: You ensure that projects comply with relevant pharmaceutical regulations, guidelines, and quality standards This may involve coordinating with regulatory affairs teams to obtain necessary approvals, managing documentation for regulatory submissions, and ensuring adherence to Good Clinical Practice (GCP) or Good Manufacturing Practice (GMP) guidelines