1019 Cgmp Jobs - Page 6

Issuance of Analytical Data Sheets and Formats. Preparation and Review of specification and standard test procedure. Review of QC Analytical Data. To ensure online documentation in laboratory as Good Documentation Practices. To attend training as per refresher training schedule. To ensure all time audit readiness in the work area. To perform any other work as and when assigned by Head of department.

1. Line clearance in dispensing, manufacturing and packing area 2. In -Process Quality Assurance activities, sampling, analysis and AQL during production. 3. To ensure stage wise completeness of BMR during production. 4. Monitoring of environmental conditions in production area. 5. Coordination with other departments for smooth running of the plant. 6. Calibration, verification and maintenance of IPQA instruments. 7. To monitor process as per technical directions. 8. To fill all IPQA sampling logs in time. 9. To ensure deviations are properly documented and CAPA implemented. 10. To withdraw samples at different stages of In-Process and finished product as well as validation samples as per TD...

As an Officer to Executive in the Production QMS Department at our company located in Bavla, Ahmedabad, your role will involve the following key responsibilities: - Injectable Production Activities: - Execute and oversee the daily manufacturing of injectable products, whether aseptic or terminal sterilized. - Adhere to batch manufacturing records (BMRs) and standard operating procedures (SOPs) throughout the production process. - Collaborate with QA, QC, and Maintenance teams to ensure seamless operations. - Quality System Support: - Manage QMS tasks including handling deviations, CAPA, change control, and updating documentation. - Participate in investigating and resolving quality events re...

Role Overview: You will be responsible for operating machines related to manufacturing and packing activities of Semi-Solid Dosage (Ointment), External Preparations & Liquid oral. It will be your duty to adhere with cGMP & SOP Compliance in the department and ensure safety & quality of the product during manufacturing & packing operations. Your main goal will be to achieve desired production targets, control wastage, and improve yield during process operations. Additionally, you will need to perform online in-process checks and make necessary entries in BPR at regular intervals, update all process records, and revise BMR/BPR, SOP, and other related documents. Key Responsibilities: - Operate ...

Experienced professional for API manufacturing operations. 1. Responsible for Handling reactor ,dryers, centrifuge 2. expected to ensure cGMP compliance and BPR review. Reach us at, +91 - 9030508200 (drop your resume) info@pharmacareerhub.net

Role Summary Data analysis, statistical modelling, and data visualization of stability studies. Applying statistical methods to identify trends, interpret data, and support organizational objectives. Key Responsibilities: Data analysis Conducting analytical similarity assessments for the products utilizing various statistical approaches, including Equivalence tests, Quality Range approaches. To extrapolate the available stability data till the shelf life of the established product and to find out the shelf life of the new products. Further, to perform the Shelf-life analysis for legacy products. To establish provisional trend limits based on the finished product data. To find out the root ca...

As a pharmaceutical water system operator, your role involves monitoring, operating, and maintaining water generation and distribution systems such as Purified Water (PW) and Water for Injection (WFI). Your key responsibilities will include: - Conducting daily parameter monitoring of the water systems - Performing regular system checks to ensure proper functioning - Ensuring compliance with strict quality and regulatory standards such as cGMP, FDA, etc. - Maintaining accurate records of system operations - Troubleshooting any issues that may arise - Supporting audits to demonstrate compliance with regulations Qualifications required for this position: - Prior experience in operating and main...

As a Quality Assurance Officer, you will be responsible for the following key responsibilities: - Issuing documents related to the shop floor. - Conducting line clearance activities. - Performing in-process checks for Tablets, Capsules, Pellets, DC granules, Dry syrups, and Packing. - Calibration of IPQA instruments. - Online documentation and review. - Monthly log book review. - Sampling and cross-checking of semi-finished, finished, reference, and stability samples. - Reviewing master documents like BMR, BPR of Tablets, Capsules, Pellets, DC granules, and Dry syrups, as well as Validation Protocols. - Batch closing and entering QQF in the ERP system. - Verifying rubber stereo indent, impre...

As an Assistant Manager in the Production department at Bavla, Ahmedabad, your role involves various key responsibilities and qualifications required: **Role Overview:** You will be responsible for following the growing procedure during and exit in clean room, manufacturing, and in the autoclave area. It is crucial to adhere to personal hygienic practices and clean room behavior in the production area. Your duties will include overseeing all activities in the dispensing and manufacturing areas, ensuring the dispensing of API and Excipients align with respective BMR and related SOPs, and performing verification processes before manufacturing operations. **Key Responsibilities:** - Reverify th...

As a Skilled Operator for Machine Operation in a pharmaceutical manufacturing company, your role involves the following key responsibilities: - Attend training sessions as per schedule and ensure training compliance with Training Needs Identification (TNI). - Perform and monitor all activities within general and controlled areas. - Fill logs, Batch Manufacturing Records (BMRs), and area documents according to Standard Operating Procedures (SOP) and work guidelines. - Clean and sanitize the area and prepare equipment following SOPs. - Follow preventive maintenance schedules for machines, instruments, and equipment in the area. - Conduct line clearance activities before starting operations in ...

Lab-scale synthesis, process optimization, reaction monitoring, experiments. Support scale-up & technology transfer, documentation: lab notebooks, experiment reports,& process records. Perform basic analytical tests , compliance: GMP, GLP, & EHS.

As a Microbiology Fresher joining our pharmaceutical quality control team, you will be responsible for performing routine microbiological testing on raw materials, finished products, and manufacturing environments to ensure compliance with regulatory and company standards. Key Responsibilities: - Perform microbiological analysis of raw materials, in-process samples, and finished products - Conduct environmental monitoring (EM) of cleanrooms and controlled areas - Carry out water testing (PW, WFI), air sampling, surface and personnel monitoring - Execute microbial limit tests (MLT), sterility tests, and endotoxin tests under supervision - Perform culture media preparation, sterilization, and ...

As a QA/QC Manager at our company, you will be responsible for liaising between various departments such as Planning, Production, Technical Services, Marketing, and Exports. Your role will involve the following key responsibilities: - Preparation, review, and implementation of SOPs and STPs. - Checking of all QC related records like analytical reports and logbooks. - Planning and distribution of samples for analysis of Raw Materials, Intermediates, and finished products. - Designing and conducting Stability studies as per ICH Guidelines. - Developing and validating analytical testing methodology used to control raw materials, production intermediates, and final products. - Preparation and ma...

Role Overview: As a Quality Assurance Officer in the manufacturing area (API), your primary responsibility will be to monitor in-process quality checks to ensure compliance with cGMP, SOPs, and regulatory requirements. Your role will involve real-time verification of manufacturing activities, documentation review, and effective communication with production and QA teams. Key Responsibilities: - Ensure adherence to cGMP and GDP practices during all in-process activities. - Perform line clearance checks before starting production and packaging operations. - Monitor and verify critical manufacturing and packaging parameters as per approved BMR/BPR. - Review and ensure compliance with SOPs, prot...

You will be responsible for preparing customer files, reviewing batch records, and releasing batch records. You will act as a liaison to our customer's quality assurance groups for batch record review and release. You will manage communication between operations/production, project management, and other quality groups. Additionally, you will approve all batch records prior to production to ensure they conform to cGMP requirements. - Timely analysis of under test samples and providing timely results - Coordinating with production for quality-related issues and clarification - Sampling and analysis for RM/Intermediate/Finished Goods - Ensuring compliance of ATR - Assisting the team in ISO impl...

You will be responsible for handling market complaint investigations and closures, coordinating with cross-functional teams for data collection and assessment, and performing thorough investigations to identify root causes of complaints. You will evaluate batch manufacturing and testing records, deviations, OOS/OOT results, change controls, and other relevant documents. It will be your duty to prepare comprehensive investigation reports within defined timelines, ensuring scientific justification for conclusions. You will also recommend and track the implementation of effective CAPA to prevent recurrence of similar issues and communicate investigation outcomes to relevant stakeholders and reg...

As a QC Chemist/Analyst, your role involves performing a variety of tasks related to quality control and analysis. Your key responsibilities will include: - Sampling of raw materials, packaging materials, intermediates, and finished products as per Standard Operating Procedures (SOPs). - Conducting chemical, physical, and instrumental analysis using methods such as UV, IR, and KF as per pharmacopeia or in-house validated methods. - Analyzing water, stability, and environmental monitoring samples. - Maintaining Good Laboratory Practices (GLP) and ensuring compliance with cGMP guidelines. - Preparing, reviewing, and maintaining accurate test records, logbooks, Certificate of Analysis (COAs), a...

As an experienced Maintenance Department professional, your role will involve: - Ensuring optimum machine availability, workforce, and shift schedules in the maintenance department, including the creation and execution of a Preventive Maintenance Plan (PPM). - Adhering to CGMP instructions, resolving technical issues, performing machine maintenance, and prioritizing safety and environmental considerations to minimize pollution and hazards, while also addressing breakdown maintenance promptly. - Taking charge of all engineering-related activities within the production plant, overseeing the preparation, verification, and review of GMP documents. - Managing the installation and commissioning of...

As an Executive/ Sr. Executive in Quality Management System (Analytical Assurance), your role will involve leading the Out of Specification investigations and managing core QMS activities related to QC. Your responsibilities will include: - Triggering out of specification investigations when test results fall outside predefined specifications. You will be required to design and conduct tests to confirm or eliminate suspected root causes. - Handling QMS documents such as Incidents & Deviations. - Evaluating change control & CAPA processes. - Reviewing analytical documents like worksheets, specifications, methods of analysis, stability protocols & summary reports, and logbooks from the Quality...

To raise and get approval of UPD / PD / Change control and get approval from authorities. Handle LMS related activities and their timely completion. To do and arrange CFT meeting of related to QMS. To receive the market complaints and get closer timely after discussion with CFT team. To review and arrangement of all GMP format requirement like formats / log etc. Prepare yearly calibration schedule and their completion timely. To implement and monitor the CAPA. To complete the schedule training / on job training . To maintain / follow the cGMP / GQS guideline requirements.. To handle change control, deviation and other GMP compliance related documents and ensure that all compliance related do...

Job Description Execution of reaction on day to day basis and support to seniors and plant Responsible of handling / maintenance of lab equipment's Strict adherence to cGMP norms and safety rules of the company Responsible for complete documentation of reaction and reaction associated therewith. To ensure calibration of lab equipment's Intellectual contribution towards new ideas pertaining to the reaction and project To be a part of the team and work towards successful and timely execution of projects. Adherence to GLP practices. To collaborate with cross functional teams wherever required To prepare weekly update and final reports Qualifications M.Sc Chemistry About Us In the three decades ...

Job Description Summary Primary focus of this position is to support optimizing, implementing, and validating components/elements of a medical device. The candidate will assist in conducting design and process qualification and validation; assist/write technical documents, validation protocols and reports; perform/coordinate hands-on testing of a device; assist in failure investigations; and support other activities from R&D, Quality, Operations, and Regulatory Affairs. Job Description Essential / Key Job Responsibilities (including supervisory and/or fiscal): Design: serve as subject matter expert of components of a medical device, including design evaluation for proposed changes to materia...

Role & responsibilities Should be able to take responsibilities assigned. Maintain proper documentation of batch records, raw material usage, and production logs. Oversee production activities as per cGMP standards. Preferred candidate profile Willing to work in shifts. Ready to learn and grow Time management and ability to work under deadlines Candidates from Ahmedabad / near by preferred.

The Opportunity The person will be responsible in preparing customer files, review batch records, and release batch records. Liaison to our customer's quality assurance groups for batch record review and release. Manage the communication between the operations/production, project management, and other quality groups. Approve all batch records prior to production to ensure that they conform to requirements of cGMP. What We Are Looking For Responsible for Timely analysis of under test samples giving timely results Coordination with production for quality related issues and clarification Sampling and analysis for RM/Intermediate/Finished Goods. Ensure compliance of ATR. Assisting team in ISO im...

Job Title: Engineering Documentation Specialist Sterile Injectable Facility (Remote India) Department: Engineering / Technical Operations Reports To: Associate Director of Engineering / Director of Engineering (U.S.) Location: Remote (India) Supporting U.S.-based pharmaceutical injectable manufacturing facilities Position Overview: The Engineering Documentation Specialist will be responsible for creating, maintaining, and managing all engineering-related documentation for sterile injectable manufacturing facilities operating under FDA 503B or cGMP environments. This position plays a critical role in ensuring technical accuracy, regulatory compliance, and timely documentation of engineering a...