234 Gdp Jobs

Role & responsibilities 1 Preparation of standard operating procedure. 2 Preparation of quality documents. 3 Initiate / review of change control system. 4 Initiate / review of deviation. 5 Initiate / review of CAPA. 6 To control, issue, retrieve, retention and disposal of GMP documents as per standard procedure. 7 Review of MFR/BMR/BPR/ECR. 8 Review of validation protocols and report. 9 To participate in investigation of OOS for RM/intermediate/FP. 10 To participate in market complaint handling. 11 Review of vendor qualification documents. 12 Review of executed manufacturing and analytical records. 13 Preparation of annual product quality review. 14 To take plant round and ensure compliance ...

As an Executive/Senior Executive in the R&D Quality-CMC QA department at Gurugram location, your role involves the following responsibilities: - Review various R&D documents including stability data, analytical reports, method qualification reports, method verification reports, method validation protocols & reports, working standard / impurity standard profile, analytical data of pilot bio batches, and method transfers protocol & report. - Review lab events, deviations, change controls, CAPA, and associated investigation reports before Technology Transfer. - Support and actively participate in failure investigations, identifying root causes for issues related to systems and products develope...

As an Associate R&D (DQA) at our company in Jhagadia, you will be responsible for the following key responsibilities: - Review Lab Validation Protocols/Reports (CRD) and Method Development/Validation documents (ADL). - Review specifications and STPs for raw materials, intermediates, and finished products. - Support DMF filings, stability studies, and regulatory documentation. - Prepare/review SOPs, logbooks, and ensure RA & GLP compliance. - Collaborate with R&D, QA, ARD, and Regulatory Affairs teams. - Support internal and external audits (FDA, ISO). - Handle DQ, IQ, OQ, and PQ documentation for equipment. - Maintain adherence to cGMP and regulatory standards. Qualifications required for th...

Role Overview: As the Vice President of Supply Chain at Piramal Critical Care (PCC), you will be responsible for overseeing, leading, and developing the Global Supply Chain for PCC. Your role will involve managing External Supply Operations, end-to-end Global Planning, Logistics, Procurement, revenue forecasting, and Supply Chain Operations/Management in each of the three regions. You will report to the EVP of Global Operations and work closely with key stakeholders both internally and externally. Key Responsibilities: - Lead and oversee cost-efficient, sustainable supply chain operations in all three regions, including Planning, Sourcing, Order Fulfillment, Inventory Management, Logistics, ...

In this role, you will be responsible for analyzing customer inputs and understanding requirements such as Design Specifications, P&IDs, Control Narratives, IO list, Instrument Index, Operating Philosophies, Cause & effect diagrams, FGS layouts etc. You will need to follow Emerson FSM process and maintain all SIS related documentation of the assigned activities as per safety lifecycle requirement. Your duties will also include verifying compliance to IEC61511/other as per assigned scope in the project, raising Technical Queries, developing Safety System SW Design, performing I/O to Safety Logic Solver Assignment, defining Software Concepts, defining third party interfaces (eg. Addressable FG...

As an Analytical R&D Scientist, you will be responsible for various tasks including calibration of analytical instruments, preparation and maintenance of solutions and reagents. You will analyze development batches, stability samples, and dissolution profiles. Your role will involve leading method development, validation, and preparing reports. Additionally, you will conduct drug solubility studies and comparability studies of active pharmaceutical ingredients and excipients. It will be your duty to monitor stability chamber conditions, maintain proper documentation, and adhere to GLP, GDP, safety protocols, and compliance guidelines. Key Responsibilities: - Responsible for calibration of an...

Role & responsibilities To manage and oversee all store operations in a pharmaceutical manufacturing environment while ensuring efficient inventory control, proper documentation, and seamless material flow using SAP. 1. Inventory & Material Management: Oversee receipt, storage, issuance, and dispatch of raw materials, packing materials, consumables, and engineering spares. Maintain accurate inventory records and ensure optimal stock levels to avoid shortages or overstocking. Conduct regular cycle counts and physical stock verifications. 2. Regulatory Compliance & Documentation: Ensure strict adherence to GMP, GDP, and SOPs related to material handling and documentation. Maintain proper docum...

Role Overview: As a Production Supervisor in the manufacturing area of multiple assigned manufacturing lines, your primary responsibility will be to ensure CGMP compliance and supervise overall production activities. You will also be required to review and maintain online documents. Key Responsibilities: - Prepare, review, revise, control, and implement standard operating procedures. - Review and prepare master documents of production. - Prepare and review protocols and reports according to requirements. - Manage documents like BMRs, BPRs, Master SOPs, etc. - Handle Change Control, Deviations, CAPA, Investigations, etc. - Conduct line clearance activities before manufacturing, filling, cappi...

DEAR CANDIDATE , WE ARE HIRING! LET'S JOIN OUR TEAM NOW! Department: R&D Position: Research Trainee / Research Associate Preferred Qualification: M.Sc. Biotechnology / M.Sc. Biochemistry Preferred candidate: Male Preferred Experience: 2 to 3 years of experience Should have good documentation skills and knowledge of GDP, GMP, GLP. Should have basic knowledge about proteins and protein purification. Should be a good team player with good interpersonal skills. Job description: Perform R&D related documentation like SOP preparation, data management and data analysis. Perform routine laboratory procedures, including buffer preparation, gel electrophoresis, western blot. Operation and maintenance ...

Role & responsibilities Implementation of Related SOPs, STP of the department Analysis of samples allotted by HOD/Seniors and recording the results Maintenance of Reference standards and preparation of working standard Storage of control sample and records Preparation and maintenance of reagents required for the laboratory Maintenance of testing documents Maintenance of Good Laboratory Practices [GLP] in QC Lab Calibration of laboratory instruments as per the schedule Handling of wet lab instruments like Fluoride meter, pH meter, Polari meter, IR and UV etc. Participate in investigation of Deviations/OOS/Complaints & CAPA if any Supervision of Cleaning glass wares Product analysis and docume...

Role & responsibilities : *Able to handle team planning and execution of shift schedule *Good knowledge on all QC related techniques like HPLC,Electro phoresis,Physiochemical, Biochemical, Immunochemical and cell based techniques *Good knowledge on QC equipment and related software *Need to ensure GLP&GDP Compliance *Good knowledge on sample management, Training Activities and QMS Elements

Role & responsibilities : *Candidate must have good hands on experience in HPLC,Electrophoretic test methods *Candidate must have good hands on experience in cell based test methods. Colorimetric, Spectrophotometer technique's. *Should be able to handle Spectrophotometer, Microplate reader microscope, basic QC instruments and relevant Software's. *Should be systematic in approach and have an idea on GLP & GDP compliance requirements. *Knowledge on QMS elements( OOS, incident Deviation, Change control etc.)

1. Operate and maintain HPLC, weighing balances, pH meters, densitometers, tube heating blocks, and other QC equipment. 2. Perform CRM-197 protein testing using HPLC and SDS-PAGE. 3. Conduct free carrier protein testing on HiBTT, HiBTi conjugate, and Pneumo conjugate using HPLC. 4. Perform molecular size testing by HPLC on HiBTT, HiBTi conjugate, and Pneumo conjugate. 5. Ensure online documentation as per Good Documentation Practices (GDP). 6. Execute method validation for various products. Demonstrate proficiency in analytical procedures and method validation. 7. Evaluate LOD/LOQ for rinse samples. 8. Verify packing materials and consumables for the Production Department. Test and release r...

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...

Ensure current versions of all GMP documents are in use. Prepare, revise, and control SOPs . Implement and enforce (GDP). Conduct internal audits, maintain summaries and CAPA tracking Support in process validation, equipment qualification etc Required Candidate profile Ensure all QA activities comply with cGMP, regulatory requirements & internal quality standards for API & Specialty manufacturing. Contact Mr Deep at 9867038868, Email Id: ops@empowerrecruitments.com

As a Laboratory Analyst, your role involves following the gowning procedure before entering the laboratory and ensuring the laboratory is always audit-ready. You will be responsible for conducting standardized and routine chemical examinations, both wet chemicals analysis and instrumental analysis for various types of samples. Your duties also include operating and maintaining lab equipment, as well as keeping detailed activity logs. It is crucial for you to maintain reference solutions and volumetric solutions in accordance with SOPs. Key Responsibilities: - Perform standardized and routine chemical examinations - Conduct quantitative and qualitative chemical analysis - Operate and maintain...

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 ...

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...

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.

Job Description JOB DESCRIPTION This role involves monitoring in-process quality checks in the manufacturing area (API) to ensure compliance with cGMP, SOPs, and regulatory requirements. The role involves 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, protocols, and regulatory guidelines . Verify sampl...

Monitor and ensure compliance with Good Distribution Practices. Handle product recalls, deviations, and complaints.Maintain quality documentation and SOPs. Ensure proper storage and handling of pharmaceutical products.

Job Title: Global Study Supply Support (GSSS) Role Overview Provide operational support to Clinical Supply Chain Study Leaders for multiple studies across all phases (set-up, follow-up, closure). Work independently and collaborate with multiple leaders and cross-functional teams. Key tasks include: Preparing and tracking transfer orders. Managing stock reconciliation. Performing quality checks. Preparing documentation for labeling and shipments. Monitoring needs for destruction. Archiving documents in the electronic Trial Master File. Key Responsibilities Support clinical supply chain operations for global studies. Ensure compliance with regulatory standards and protocols. Maintain accurate ...

The In-Process Quality Assurance (IPQA) Executive will be responsible for ensuring product quality during various stages of the manufacturing process. This role plays a critical part in maintaining compliance with cGMP, SOPs, and regulatory standards. The candidate will work closely with manufacturing, quality control, and cross-functional teams to ensure the delivery of high-quality and compliant products. Responsibilities: Monitor in-process activities to ensure adherence to defined quality standards and SOPs. Perform line clearance, online sampling, and verification during manufacturing and packing processes. Record deviations and non-conformities observed during operations and support in...

Handling of Change control, Handling of Deviation and CAPA management system, Handling of Internal and external audits, Sound knowledge about Equipment and Utilty qualifcation, Should have thorough understanding about regulatory guidelines, cGMP norms, GLP, GDP, Data integrity requirements etc. Should have experience of regulatory audits.

You will be responsible for following standard practices cGLP during lab experiments, cleaning verification method development, API method evaluation and verification, API solubility study assessment, working standard qualification, method development and verification of drug product formulation, ARF release of raw material and packaging material, preparation of test procedures for routine development analysis, column management, TOC sample analysis, ensuring in-house compliance system, maintaining hygienic conditions in the respective department, and following GxP (GMP, GDP, GLP) for all processes. Key Responsibilities: - Follow cGLP during lab experiments - Develop and verify cleaning veri...