316 Gmp Compliance Jobs - Page 10

QA Executive For Agro chemical Industry In Saykha,Bharuch, Gujarat Bharuch, Ahmedabad, Vadodara Job description Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications and Analytical Standards Required Candidate profile Work to create an environment of open communication, participation &information-sharing within & between teams within QA &throughout facility

Compliance of GMP & GMP Documents, GRN Preparation, Receipt, Handling and Issuance of Material. Manpower Utilization Skills, Compliance with Internal as well as External Audits, Dispensing of Materials. ERP System, Follow and Implementation Required Candidate profile B. Com / B. Sc / Diploma Material management

Responsibilities: Lead factory ops, ensure GMP compliance & ISO doc prep. Collaborate with R&D on new product launches & scale-up plans. Oversee API manufacturing processes & quality control measures.

Responsibilities: chromatographic techniques. TFF system. Filtration. Document processes accurately. maintain GMP standards Prepare buffers according to specifications

JOB DUTIES AND RESPONSIBILITIES (Please Mention In Below Table) 1 Manage release of product batches, including owning the QA product release workflow in SAP. 2 Lead and supervise a team of QA professionals to perform operations as described above. 3 Review and approve Deviation and Laboratory Investigations 4 Review and approve Purchase Specifications and Analytical Standards 5 Review and approve Issue Reviews and CAPA 6 Assist with Non-Conformance Investigations and provide guidance in identifying potential product impact and determination of final product disposition 7 Review and update Standard Operating Procedures (SOPs) for GMP compliance 8 Follow all regulatory guidelines, cGMP guideli...

Job Duties and Responsibilities (Please Mention In Below Table) 1 Manage release of product batches, including owning the QA product release workflow in SAP. 2 Lead and supervise a team of QA professionals to perform operations as described above. 3 Review and approve Deviation and Laboratory Investigations 4 Review and approve Purchase Specifications and Analytical Standards 5 Review and approve Issue Reviews and CAPA 6 Assist with Non-Conformance Investigations and provide guidance in identifying potential product impact and determination of final product disposition 7 Review and update Standard Operating Procedures (SOPs) for GMP compliance 8 Follow all regulatory guidelines, cGMP guideli...

Responsibilities: * Ensure GMP compliance through documentation & filter integrity checks. * Prepare buffers according to SOPs using chromatography techniques.

Oversee the daily operations of the packaging department, ensuring the timely and efficient packing of pharmaceutical products. Supervise and guide the packing team to ensure adherence to production schedules. Ensure the packing area is organized, clean, and compliant with GMP (Good Manufacturing Practice) guidelines. Coordinate with other departments like Quality Control, Supply Chain, and Production to align on daily targets and deliveries. Ensure that the packaging process adheres to all GMP, GLP (Good Laboratory Practice), and regulatory requirements (FDA, WHO, etc.). Monitor and ensure that proper documentation is maintained for each batch (batch records, labeling, and packaging). Condu...

Operate and monitor compression machines (e.g., Cadmach - ACC). Ensure smooth execution of batch production as per BMR/BPR and SOPs. Carry out in-process checks (IPC) like weight variation, hardness, thickness, friability, etc. Perform machine changeovers, cleaning, and line clearance. Maintain and update Batch Manufacturing Records (BMRs), logbooks, equipment usage logs. Adhere strictly to cGMP, GDP, and safety norms. Participate in audits (internal/external) and handle compliance requirements. Collaborate with QA, maintenance, and validation teams. Report deviations, breakdowns, and implement corrective/preventive actions (CAPA). Suggest and implement process improvements for yield and pro...

Supervise and coordinate QA lab personnel and activities related to sampling, testing, and reporting of raw materials, in-process samples, and finished products. Ensure compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and regulatory guidelines (e.g., FDA, ISO, ICH, etc.). Review and approve analytical test results, COAs (Certificates of Analysis), and related documentation. Manage calibration, maintenance, and validation of laboratory instruments (e.g., HPLC, GC, UV-Vis, FTIR). Investigate out-of-specification (OOS), out-of-trend (OOT), and non-conformances; participate in root cause analysis and CAPA implementation. Ensure timely completion of stability s...

DESIGNATION: Assistant Manager-R&D FUNCTION: Research & Development REPORTING TO: Chief R&D Officer LOCATION: Manesar EMPLOYMENT TYPE: Permanent Roles and Responsibility: . Responsible for developing new products. Process developing, verifying, implementing and maintaining which leads to a safe, hygienic and quality product conforming to standards and company requirements. Carry out Shelf life studies. Ability to manage a team in order to undertake trials in manufacturing facility. Ensure all raw materials and finished good recipes created are FSSAI compliant. Manage Supervision and monitoring of cleaning and sanitation procedures of lab equipment, cleanliness of the laboratory. Responsible ...

JD: Inventory Management FTE The employee is responsible for performing activities in compliance with current established procedures of Safety and Quality. Main and additional duties are mentioned below: Responsible for Inventory management for Lab chemicals/Solvent, Reference standard including procurement, receipt, issuance. Responsible for Inventory management for Glasswares, including procurement. Responsible for Inventory management for Lab stationary items, including procurement, receipt, distribution. Responsible for executing activities in EDMS as per assigned roles and as per applicable procedures. Responsible for Inventory management for chromatography columns, including Procuremen...

Purpose of the position Programming of Siemens S7 control software Testing of systems before delivery Supporting commissioning at the customers site Handling support cases and troubleshooting system-related issues Creation of Control Documents (P&ID,I/O, cable list, termination details). Role & responsibilities Advanced knowledge of Siemens S7/TIA control and WinCC Advanced/Unified/7.5 Knowledge of measurement, control and regulation technology Independent, structured, and systematic approach to work Good problem solving and analytical skills Knowledge of EPLAN and PC technology Extensive knowledge of the WAB product range Experience with GMP (Good Manufacturing Practice) Knowledge of machin...

Responsibilities: * Oversee supply chain management & communication with stakeholders * Ensure GMP compliance throughout outsourced operations * Manage supplier relationships & performance monitoring

Role & responsibilities Job Responsibilities/Descriptions Primary Responsibilities: 1. To ensure shop floor compliance of Visual Inspection, Packaging, warehouse and Dispatch operations as per cGMP and cGWP requirements (IPQA activities). To prepare and review SOPs, study protocols, SPRs, TPRs pertaining to Fill finish, warehouse and quality assurance as required. 3. To Support in visual inspection qualification kits and visual inspection operator qualifications. 4. To review the trends of visual inspection results. 5. To support the Validation Team during the qualification activities at the area. 6. To provide Line Clearance for Visual Inspection, Packaging, Dispensing and Dispatch operatio...

Roles and Responsibilities 1. Responsible for production machinery operation and maintenance activity 2. Checking the day logbooks and maintain all data in control. 3. Train the new operators for the filling machine and sterilizers. 4. co ordinate with supplier for spares development and final design. 5. Responsible for Mould change over in FFS (Form Fill Seal) and ISBM (injection stretch blow Mould) machine as per product size. 6. Responsible for product targets,rejection control and yield maintenance at filling stage for each filling lines. 7. Responsible for production sterilizer maintenance and assist in operational problems. 8. Responsible for maintenance of production vessel and autocl...

Key Deliverables: Develop and execute validation protocols (IQ/OQ) for GxP-compliant systems Design automated test suites for APIs, data pipelines, and custom software Collaborate with cross-functional teams to ensure validation and documentation compliance Maintain validation documentation aligned with Amgen SOPs and regulatory standards Role Responsibilities: Participate in Agile test planning, estimation, and execution Analyze test results and drive root cause analysis with development teams Ensure system validation aligns with 21 CFR Part 11 and GMP guidelines Lead validation improvement initiatives and contribute to QA automation framework

Role & Responsibilities: Physically verify raw materials and packaging per COA and MRN documentation Conduct routine checks on FG and SFG for pH, moisture, content, density Supervise personnel hygiene and ensure compliance with safety protocols Maintain calibration records for lab instruments Conduct pest inspections and ensure hygienic conditions Support R&D trials for quality improvements in FMCG products Perform shelf-life tracking and stock audits Ensure FoSTaC certification and food handler medical checks Follow up on market complaints and escalate quality issues Verify new packaging designs for compliance and legibility Maintain BOMs with Accounting for alignment with production and fi...

Role & responsibilities Sr.Executive : QMS & engineering documentation Primary Responsibilities: 1. Responsible for GMP compliance, as per procedures define and implementations of GxP practices. 2. To ensure the GDP and data integrity in routine/daily activities/operations. 3. Responsible for QMS documents related to engineering. 4. Audits & compliance 5. Preparation of SOPs, review & periodic revisions 6. To attend /or supervise all jobs related to Electrical/ Instrumentation Engineering activities at site. 7. Timely execution of equipments/instruments as per schedule coordination with user. 8. To attend emergency breakdowns of all plant wide machines round the clock as and when required. 9...

Role & responsibilities 1. Take responsibilities as Study Director for conduct of studies as per GLP principles/ GMP guidelines. 2. Prepare/revise SOPs, formats, logbooks, and ensure test facility implementation 3. Draft study plans, record raw data, study reports, and maintain forms B/D and MSS updates 4. Handle requisition of chemicals, reagents, study related materials. 5. Oversee dosing, observations, necropsy, organ collection, weighing or any other study related activities. 6. Analyze study data with computerized tools ensuring their validation status. 7. Ensure qualification/calibration/AMCs of lab instruments. 8. Organize and complete internal and external SOP/regulatory trainings an...

Profile Overview: The Shift Engineer Production, will be responsible for supervising and executing endto-end production activities during the assigned shift at a rigid plastic packaging manufacturing unit. This role ensures timely job setups, smooth machine operation, manpower coordination, and strict adherence to quality and safety protocols. The ideal candidate will have hands-on experience in plastic molding processes and be proactive in resolving production challenges to meet daily output and quality targets. Plant Location: Silvassa, Gujarat. Department: Production Industry: Rigid Plastic Packaging Manufacturing Reporting To: Production Manager / Plant Head Note: 1. Open to Fresher Eng...

Role & responsibilities :- Perform and approve Sterility Testing using direct inoculation or membrane filtration methods as per pharmacopeial standards (USP, EP, IP, JP). Supervise aseptic testing procedures in ISO Class 5 (Grade A) environments within validated sterility testing isolators or LAFs . Ensure environmental monitoring , personnel monitoring , and media fill (ASEPTIC Process Simulation) activities are conducted and reviewed as per schedule. Approve microbiological testing results, including bioburden , endotoxin , water testing , and identification of microorganisms . Conduct investigations of microbiological OOS/OOT results and deviations , and support implementation of correcti...

Job Title: Sr. Executive HR Department: Human Resources Location: Dahej Company: Cadila Pharmaceuticals Ltd. Job Purpose: To efficiently manage HR operations and administrative functions including employee data management, onboarding, training coordination, facility oversight, and compliance with SOPs and GMP/GDP training requirements. Key Responsibilities: Maintain employee records, attendance, and leave data using HRMS or manual systems. Support onboarding, induction, and documentation of new employees through DigiCad and other internal processes. Coordinate training programs, maintain training records, and monitor GMP/GDP training and refresher compliance. Track and report contract/outsou...

Support the R&D Team on various Projects in terms of Package System Design / Implementation support. The development of complete package concept and specifications, and improvements to existing packaging configurations. Application of new technologies, materials and cost reduction projects where appropriate. The role includes the opportunity to lead and participate in cross-functional projects involving packaging Design and all other aspects of medical device technology. Ensure quality of packaging design aspects of product as defined in appropriate SOPs and Material Specifications. Ensure GMPs and process safety guidelines are adhered to. Training of support staff and manufacturing team mem...

Role Responsibilities: Operate and maintain chromatography columns (BPG/Chromoflow) and TFF systems Perform centrifugation, filtration, buffer preparation, and CIP/SIP Follow GMP guidelines and document procedures under QMS Support buffer and media preparation for downstream biologics production Key Deliverables: Execute downstream biologics processes as per batch protocols Maintain equipment logs and ensure process hygiene Support audit readiness through accurate documentation Ensure timely completion of downstream operations