1027 Cgmp Jobs - Page 19

Ensure GLP,GDP, STPs, SOPs & SOIs. Calibrate & maintain HPLC, Rheometer, Viscometer, balances. Perform analytical methods and Q3/PEQ characterization studies. Protocols,reports,reagents,routine analysis, PSD, rheology, viscosity, and related studies.

About the Role We are looking for a meticulous Web Application Reviewer to ensure the accuracy, quality, and usability of data and content within our web applications. The role involves reviewing images, validating extracted data, comparing records, and making acceptance or rejection decisions with clear reasoning. The ideal candidate should be comfortable navigating web applications, understanding their functionalities, and leveraging related technologies to efficiently complete tasks. Key Responsibilities Review images and data uploaded into the web application with attention to detail. Validate extracted information against source images or documents. Accept or reject records within the a...

Qualification :- B. Pharm / M.Pharm Experience :- 4 to 6 years in Pharmaceutical manufacturing , R&D or Tech Transfer Salary :- up to 7 LPA Location :- Changodar GIDC (Ahmedabad) Solid understanding of formulation scaleup and tech transfer

Responsibilities: Ensure compliance with regulatory requirements through CSV processes. Implement LIMS, Labware Lims & DMS systems. Conduct CSV activities for equipment validation. Health insurance Annual bonus Provident fund Flexi working

You will be joining Biocon Biologics, a subsidiary of Biocon Ltd, a global biopharmaceuticals company focused on developing high quality and affordable biosimilars to provide cutting-edge therapies to patients worldwide. As a fully integrated pure play biosimilars organization, Biocon Biologics aims to improve patient lives through innovative and inclusive healthcare solutions. With a large portfolio of biosimilars in global clinical development and commercialized products in developed markets like EU, U.S., and Japan, Biocon Biologics is committed to transforming healthcare and impacting millions of lives. Your role at Biocon Biologics will involve the following key responsibilities: - Adhe...

As a candidate for the position, you should possess the following qualifications: - Diploma in Pharmaceutical Science Discipline/Engineering - Knowledge on manufacturing of pharmaceutical dosage forms - Preferably experiences in good understanding of manufacturing and quality systems - Familiarity with cGMP and application of quality management systems - Proficiency in good documentation practices - Technical writing and document review skills - Ability to write and revise standard operation procedures (SOP) and related manufacturing documents - Strong interpersonal skills - Analytical thinking to grasp complex technical issues and provide feasible solutions by discussing with superiors - De...

Job Description: Site Project Engineer (HVAC & Cleanroom Projects) Company: Syntec Airflow Systems Location: Project Sites in and around Gurugram, Haryana Job Type: Full-Time About Syntec Airflow Systems: Syntec Airflow Systems is a leading provider of advanced HVAC and turnkey cleanroom solutions. We specialize in designing, manufacturing, and installing precision-engineered environments for critical industries, including pharmaceuticals, biotechnology, microelectronics, and healthcare. Our commitment to innovation, quality, and client satisfaction has made us a trusted partner in delivering state-of-the-art controlled environments. Job Summary: We are seeking a dynamic, detail-oriented, an...

As a Process Engineer, you will be responsible for supporting basic and detailed engineering design in process industries. Your role will involve preparing heat/mass balances, equipment sizing/selection, PFDs, P&IDs, BOMs, and datasheets. Additionally, you will coordinate with vendors, control costs, and provide on-site support. You will engage in technical discussions with stakeholders, clients, and consultants, offering technical input throughout the project lifecycle. Key Responsibilities: - Perform process calculations including line sizing, pump hydraulics, heat exchangers, and selection of control valves/PRVs/PSVs. - Develop and review PFDs, P&IDs, datasheets, and technical specificati...

Planning and execution of preventive maintenance of Process equipment- Vial filling, vial washing, Tunnel, isolators. Online entering check list for carrying a preventive maintenance as per SOPs. Attending breakdown maintenance in compliance with cGMP of process equipment's. Following the cGMP, GDP and safety while carrying out all activities. Maintaining good co-ordination with other department to sort out plant maintenance issues. Spares Management for all process equipment's. Operation and maintenance of HVAC system. Ensure maintaining of clean room parameters and trouble shooting. Operation of HVAC Requalification. To communicate relevant EHS issues to concerned person. Plan and preparat...

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including...

Oversee and manage daily production activities Ensure adherence to cGMP and EHS guidelines Coordinate with cross-functional teams for smooth operations Optimize processes for efficiency and quality

Followings will be the Core Job Responsibilities of the position holder: Compliance of current Good Manufacturing Practices in the Hormone Facility & to follow GDP with data-integrity compliance. Responsible for achieving monthly and yearly target of production department. Alarm Identification and management as per SOP. To ensure all in-process checks and monitoring of all intermediate processes, to check set process parameters in PLC/SCADA as per BPR. Responsible to operate the Packaging machine as per respective equipment operation SOP. To identify the problems with the machine and undertake trouble shooting activity where required, to ensure work is carried on in the Packing section accor...

We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job you will find purpose and pride. To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and all To enumerate and report the tubes and plates and to supervise the discarding method of the same. To perform periodic microbiological tests, as per Standard Operating Procedure (SOP). To perform the Bacterial Endotoxin Test. To test the material for their pre-sterile bio-burden and to test Raw Material (RM)/ Packing Material (PM) for bio-burden test. To co-ordinate with Technical department for...

To ensure and carry out the analysis of stability sample and all other activities as per Standard Operating Procedure (SOP). To get involve and support in investigation of failure of any material or product in case of any out of specification (OOS) or Out of trend (OOT) or laboratory incident or non-conformity and take corrective and preventive actions. To raise and implement change control or document change request wherever necessary. To follow and ensure Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) inside Stability lab. To ensure availability of the working & impurities standards as per various pharmacopoeia. To assist Supervis...

Post - API Pharma Production Engineer Location - SUPA Ahmed Nagar Experience - 02-04 yrs Email - punemechanical@gmail.com Contact - 9356395439 Skills - API , Pharma Production , PPC Education - BSC / MSC Chemistry / Bio technology

Role & responsibilities Operate aerosol filling and packaging machinery including spray dryers, capsule filling, blister packing, and secondary packaging equipment Perform weighing, blending, dispensing, mixing, granulating, drying, and coating processes as per batch production records Conduct machine changeovers and setup for different product batches. Monitor equipment parameters and ensure operations are within defined specifications. Ensure compliance with SOPs, cGMP, and regulatory requirements. Participate in audits and inspections as required. Perform routine equipment cleaning and maintenance. Assist in troubleshooting and resolving equipment issues.

Job Title: AQA Quality Assurance (LCMS, GCMS, ICPMS) Company: Energon Labs Location: Hyderabad Experience Required: 2 - 6 years Employment Type: Full Time, Permanent Role Overview We are seeking experienced professionals in Analytical Quality Assurance (AQA) to review and ensure compliance in analytical data generated through LCMS, GCMS, and ICPMS techniques. The role requires a keen eye for detail, strong knowledge of analytical methods, and the ability to uphold the highest quality standards. Key Responsibilities Review analytical data for LCMS, GCMS, and ICPMS techniques. Conduct electronic audit trail reviews for analytical instruments and ensure compliance. Review Analytical Method Vali...

QA role in API manufacturing. Responsibilities: Documentation, internal/vendor/regulatory audits (USFDA, WHO, EU), deviation handling, validation, CAPA, QMS compliance, and conducting training to promote quality culture. Office cab/shuttle Provident fund

Role Overview: You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. In addition, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your duties. Key Responsibilities: - Review and approve all documents including SOPs, Spec & STPs, Forms, protocols, and reports to ensure compliance. - Review annual product quality review reports and provide training on cGMP topics to employees at the site. - Support customer audits/visits and regulatory a...

Role Overview: You will be responsible for leading end-to-end execution of greenfield/brownfield injectable facility projects. This includes covering design, budgeting, procurement, construction, commissioning, and qualification. Your main focus will be on ensuring uninterrupted and compliant operation of critical utilities such as WFI, Pure Steam, RODI, HVAC, Compressed Air, Nitrogen, and chilled water systems. Key Responsibilities: - Ensure all systems and documentation meet cGMP, GEP, and regulatory standards like USFDA, EU-GMP, WHO-GMP. - Prepare for and support audits and inspections, collaborating with QA, Production, Validation, and EHS teams. - Manage third-party vendors, consultants...

Role Overview: The Shift Chemist at Pharma Manufacturing department is responsible for achieving the desired production yield of pharmaceutical APIs by ensuring all production activities in the shift comply with cGMP, cGLP, EHS requirements, and specified operating procedures. You will be required to properly take over shift operations as per defined procedures. This includes following the Gowning Procedure before entering the pharma area, indenting raw materials from stores, updating balance in Material Reconciliation Record, collecting Intermediate material, ensuring availability of Utilities before charging the batch, verifying and charging raw material quantities, executing production pr...

As a Manufacturing Supervisor, your role involves ensuring efficient line clearance activities, preventive maintenance of machines, cleaning and sanitizing visual inspection and packing areas, operating machines, and maintaining logs as per SOPs. You are also expected to uphold cGMP, GDP standards, and enforce discipline within the department to ensure uniform compliance among all employees. Key Responsibilities: - Perform line clearance activities before commencing operations - Follow the preventive maintenance schedule of machines - Clean and sanitize visual inspection and packing areas - Operate machines and maintain logs according to SOP - Ensure adherence to cGMP, GDP, and discipline st...

As a qualified candidate, you will be leading the Quality Assurance, QC Chemistry, and Microbiology Laboratories for the site. Your role will involve developing Standard Operating Procedures (SOPs), ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory guidelines, and monitoring day-to-day department activities. Responsibilities include reviewing and approving documents, executing in-process controls, participating in investigations, vendor qualification, stability management, and ensuring safety practices. - You will be responsible for organizing the recruitment and training of QA (Quality Assurance) and laboratory personnel for chemistry and microbiology labor...

As a machine operator at our pharmaceutical manufacturing company, you will need 1 to 2 years of experience in relevant machine operations within the industry. Your understanding of cGMP and quality control principles will be crucial in ensuring the smooth operation of our machines. Working in a fast-paced environment, you will be expected to meet production targets efficiently, requiring excellent communication and teamwork skills. Your key responsibilities will include: - Operating Blister and Alu Alu machines effectively - Following standard operating procedures for machine operation - Ensuring the quality and quantity of production meets standards - Performing regular machine maintenance...

As a Manufacturing Specialist in our company, your responsibilities will include: - Performing line clearance activities before commencing operations to ensure a clean and sanitized visual inspection and Packing area - Following the preventive maintenance schedule of machines - Operating the machines efficiently and filling the log of general areas as per SOP and work execution - Adhering to cGMP, GDP, and maintaining discipline in the department - Ensuring that all employees comply with the same standards Your role will also involve: - Ensuring that all equipment and production lines are in validated and calibrated status - Preparing daily production reports based on achieved targets - Crea...