15 Gmp Documentation Jobs

As the Packing and Visual Inspection Supervisor in the fill-finish area, your role involves overseeing the packing and visual inspection operations. Your key responsibilities will include: - Supervising overall packing and visual inspection operations in the fill-finish area. - Preparing and maintaining GMP documentation such as SOPs, BPRs, protocols, reports, and equipment qualification documents. - Ensuring all fill-finish packing equipment is installed, qualified, and maintained in operational condition. - Managing material inventory to ensure timely availability for packing operations. - Planning and executing batch packing activities according to production schedules. - Performing opera...

Key Responsibilities: Perform preventive and corrective maintenance of formulation equipment such as blenders, granulators, compression machines, coating machines, FBD, RMG, auto-capsule filling, packing machines, etc. Monitor equipment performance and ensure minimum downtime with quick troubleshooting. Maintain SOPs, maintenance logs, calibration reports, and other GMP documentation. Coordinate with production and quality teams to ensure timely breakdown resolution. Assist in installation, validation, and qualification (IQ/OQ/PQ) of equipment. Ensure compliance with safety, regulatory, and audit requirements. Work with vendors and service engineers for spare parts procurement and AMC manage...

Supervise overall packing and visual inspection operations in the fill-finish area. Prepare and maintain GMP documentation , including but not limited to SOPs, BPRs, protocols, reports, and equipment qualification documents . Ensure all fill-finish packing equipment are installed, qualified, and maintained in operational condition. Manage material inventory and ensure timely availability for packing operations. Plan and execute batch packing activities in line with production schedules. Perform operation, verification, calibration, and cleaning of weighing balances (1.5 kg). Oversee labelling, packaging, and visual inspection activities , ensuring accuracy and compliance with GMP. Conduct vi...

1. Role Title: Specialist - Facility & Operations 2. Department/Function: Facilities & Operations - Technical Operations & Inventory 3. Reporting Structure: Reports to: Technical Operations and Inventory Direct Reports: Individual contributor 4. Role Summary: This position must implement and execute the operating guidelines for the cleanroom facility. It should also be able to manage technical operations by anticipating demand and arranging the supply of all cleanroom requirements. Implement the strategy to keep the clean rooms operationally sound and maintain the standards for smooth operations. The person should act as a SPOC for all operational activities related to all labs and activitie...

Urgent Hiring For Manager - Admin & HR (manufacturing Industry ) Location Bangalore Sriramanahalli, Near Rajankunte,/ Bashettyhalli Industrial Area Salary UPTO 6 LPA Experience Minimum 3 years of HR experience in a manufacturing environment Note Immediate joiners will be highly preferred Job Summary: We are seeking an HR professional with an MBA in HR and a minimum of 3 years of experience in a Manufacturing setup. The role includes managing HR operations, payroll, statutory compliances, labour Contract management, GMP documentation, manufacturing unit compliances, and safety management. Key Responsibilities: ? Manage end-to-end payroll and statutory compliance (PF, ESIC, Bonus, etc.) ? Hand...

As an experienced Regulatory Affairs Consultant with specialized knowledge in lipid-based pharmaceutical products, particularly Fish Oil Triglycerides such as EPA/DHA omega-3 fatty acids, your role will involve providing regulatory support and strategic guidance for drug, dietary supplement, or nutraceutical products containing fish oil derivatives to ensure compliance with global regulatory standards including FDA (CDER & CFSAN). You will be a crucial resource within the organization, offering technical expertise and regulatory guidance for the development, manufacturing, and commercialization of lipid-based pharmaceutical products. Your role will require strong cross-functional collaborati...

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Unique Opportunity Thermo Fisher Scientific Inc. seeks a Sr Packaging/Labeling Technician to support premier packaging and labeling. Job Responsibilities Handle and perform floor level activities of secondary packaging to complete the packaging jobs within defined timelines and with the desired quality standards. Ensure that all team members technically adh...

You will be responsible for implementing and executing the operating guidelines for the cleanroom facility and managing technical operations by anticipating demand and arranging the supply of all cleanroom requirements. Your role will involve acting as a Single Point of Contact (SPOC) for all operational activities related to labs and activities, ensuring the smooth functioning of all labs, improving existing systems and processes, and maintaining operational standards. Key Responsibilities: - Managing day-to-day site operations for all the labs - Supervising and directing on-site instrument and equipment Calibration and qualification - Generating and reviewing GMP documentation such as Stan...

Machine Operation Visual inspection Good Manufacturing Practices Documentation

Responsible for any packaging related activities in development lab or GMP area. Preparation of Master Packaging Card (MPC), batch packaging record (BPR) along with other GMP & Non GMP packaging documents (protocols, reports etc). Development of New change parts for blister packing. Review of executed and master batch packaging records. Taking care of GMP documentation including change control, SOP, deviation, market complain etc. Innovator pack analysis and report preparation. Preparations of departmental SOP. Initiation of Change control, Deviation and CAPA in Track Wise for Packaging related activities. Coordination with supplier for development of new/existing Packaging Materials or chan...

You will be responsible for supervising and guiding the IPQA team to conduct real-time monitoring during manufacturing and packing processes. Your role will involve ensuring compliance with BMR/BPR review and approvals at each stage, as well as overseeing line clearance before manufacturing and packaging activities. It will be essential to monitor critical process parameters, in-process checks, and control sampling activities including IPC, stability, validation, etc. You will be expected to ensure timely review and approval of executed batch records and logbooks, review and ensure compliance of standard operating procedures (SOPs), and maintain and control GMP documentation related to IPQA ...

This role requires you to be highly skilled in technology transfer of Injectable products to manufacturing plants, including scale-up activities and demonstrating technical capabilities. You will play a key role in ensuring accessibility to both current portfolio and pipeline products. Additionally, you will share responsibility for achieving targeted product execution goals within the department/organization. Your duties will involve documentation, evaluation, and monitoring of batches at the manufacturing site. Your responsibilities will include performing product transfer activities for sterile products as assigned by the Manager/Senior Manager/Designee. You will be involved in the execut...

The Engineering Department at Zydus Biotech Park in Changodar, Ahmedabad is looking for a qualified candidate for the position of Executive/Senior Executive - Instrumentation. The ideal candidate should hold a B.E. degree in Instrumentation and Control with 3 to 5 years of relevant experience. As an Executive/Senior Executive - Instrumentation, your primary responsibilities will include conducting preventive maintenance of plant/process equipment, performing calibrations, and ensuring the qualification of equipment and SCADA systems in compliance with 21 CFR guidelines. You will also be responsible for troubleshooting SCADA, PLC, and instruments as needed. Additionally, you will be in charge...

Should have experience into sterile cleaning. Must have hands-on experience in logbook maintenance and GMP documentation. Mandatory to have ideal communication skills and good writing skills.

Location: Gurgaon Department: Research &Development (API) Key Responsibilities: Observe process in the laboratory and generate data for scale up working with chemistry teams in kilo lab and pilot plant. Design experiments using DoE (Design of Experiments) and perform reaction engineering studies for critical unit operations. Evaluate process scalability, safety, and sustainability for seamless technology transfer to the manufacturing plant. Carry out necessary process engineering calculations for scale up of unit operations. Prepare mapping, material and energy balance for the process. Develop and maintain process documentation: PFDs, P&IDs, risk assessments, scale-up reports, and technology...