123 Gmp Compliance Jobs - Page 3

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 guidelines, Environmental Health and Safety regulations as required by the job function Review validation protocols and completed documents, including process qualification protocols for validations of commercial processes. 9 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility

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 guidelines, Environmental Health and Safety regulations as required by the job function Review validation protocols and completed documents, including process qualification protocols for validations of commercial processe 9 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility 10 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility 11 Assist with complaint investigations for internally produced commercial product 12 Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable). 13 Ensure all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules

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). Conduct in-process checks to ensure that the packing is done in accordance with the standard operating procedures (SOPs). Oversee the operation and maintenance of packing equipment and machinery. Ensure that packing machines are calibrated and maintained properly. Coordinate with maintenance staff for the timely servicing and repair of equipment. Monitor and maintain the efficiency of packing lines and troubleshoot any issues that may arise during production. Identify areas of improvement in the packing process to enhance productivity. Assist in implementing continuous improvement projects to optimize packing operations. Maintain adequate inventory levels of packing materials (bottles, cartons, labels, etc.). Work with the supply chain department to ensure smooth availability of materials and resolve any shortages or delays.

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 productivity.

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 studies and trending of data.

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 for adequate storage and proper disposal of materials as per company requirements Ensure the calibration of lab equipment as per company requirements. Maintaining personal hygiene of self and lab staff to maintain GMP and GHP score. Ability to find the root cause analysis & corrective action plan WHAT YOU WILL NEED: Effective Team player Adhere to company's administrative policies and procedures. Ability to understand and manage the objective and targets of the departments. Work in environment friendly manner by using resources intelligently and reducing wastages. Ability to participate in cross-functional teams to achieve specific goals and objectives. Basic Computer knowledge (MS office, Internet surfing) B.Tech. in Food Technology Minimum 3 years experience in Food Industry either in R&D or Product Application. What We Expect: Our culture is built on mutual trust, integrity, and ethical conduct. We prioritize transparency, accountability, and respect to foster collaboration. Employees are encouraged to take ownership, act responsibly, and build strong professional relationships. Together, we create a workplace rooted in trust and shared commitment. WHAT WE PROMISE At Hector Beverages, we promise an environment built on trust, fairness, and integrity, where every individual feels valued and empowered. We believe in open communication, ethical leadership, and a workplace that nurtures transparency and inclusivity. Our commitment to innovation means that employees will always have the support, tools, and freedom to experiment, take risks, and bring bold ideas to life.

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 Procurement. Responsible for creation of GRN for Lab related items. Responsible for maintaining various databases in the lab. To execute the task according to the cGMP guidelines. Responsible for filing of ELIMS worksheets and other documents. Responsible for all the activities assigned in the Lab responsibility list. knowledge of excel/ pivot table. Ability to extract technical information, such as given on SDS, COA, test method for a specified reagent and then place the order GMP Responsibility •To execute the tasks according to the cGMP guidelines and established laboratory procedures. •To document execution details contemporaneously and verify completeness of execution record as per established laboratory procedure. •To always comply with procedure and ensure lab is in state of audit readiness. Quality & Compliance Responsibilities •To ensure that respective guidelines on data integrity and laboratory control processes are followed as per established SOPs. •To ensure immediate escalation of issues/observations not in conformity with applicable procedures /policies etc.

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 machinery safety regulations Understanding of ATEX regulations for hazardous environments Knowledge of DQ, IQ, OQ Knowledge of SCADA will be an advantage Supporting the company electrician Preferred candidate profile Understanding process sequences and creating PLC programmers Creating visualizations with WinCC - Advanced/Unified/7.5 Parameterizing of VFDs Optimizing existing controls and processes Solving application-specific electrical customer problems Performing quality assurance tasks in accordance with the quality manual and connected documentation

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 operations, verification of In-Process checks as defined in the batch records / SOPs. 7. To perform AQL Visual Inspection of filled units as per SOP / instructions. 8. To perform Pre-Dispatch Inspection (PDI checks). 9. To verify and ensure routine compliance of Visual Inspection and Packaging activities as per the batch records/SOPs and verification of the online documentation against each process stage, including logbooks 10. To Suppott Artwork development and management. 11. To Support in Transport Validation of Finished Products. 12. To Support and facilitate timely closure of Change Controls, Events / Deviations, CAPA pertaining to Visual Inspection and Packaging areas, support investigations. 13. To co-ordinate with all cross functional departments for operations related to Quality Assurance. 14. To ensure the readiness of shop floor for audits by Regulatory Authorities / customers. 15. To support market compliant investigations. 16. Ensure to perform daily random checks on material reconciliation at warehouse and report the discrepancy. 17. Ensure the warehouse documents verification and its compliance. 18. To Support and facilitate timely closure of Change Controls, Events / Deviations, CAPA pertaining to warehouse and Dispatch areas; support investigations. Secondary Responsibilities: 19. Follow the safety precautions at packing and warehouse areas. 20. Support the internal audits. 21. Any other responsibilities assigned by supervisor / head of the department.

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 autoclave. 9. Maintain the online training records. 10. Maintain the production filling and sterilizers history and its data. 11. To fill QMS activities like CAPA, Change control and deviation.

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 finance Lead GMP, HACCP, and FSSAI audit readiness efforts Coordinate fire safety drills, hygiene inspections, and corrective action Preferred Candidate Profile: 5 -10 years in FMCG, food production, or confectionery Proficient in HACCP, FSSAI guidelines, and FoSTaC Strong recordkeeping and documentation mindset Proficient in Telugu, Hindi. Experience in managing audits and lab instruments

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. Maintain the Spare parts of all critical Instruments in site. 10. Timely execution and completion of Validation/ Qualification activities at site. 11. Execution of all In-house Projects in Electrical/ instrumentation in site. 12. Maintain the calibration logs, area /equipment logbooks, preventive maintenance schedule of all the activities. Preferred candidate profile

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 and implement the procedures in test facility. 9. Oversee preclinical toxicity and PK/PD studies under GLP/GMP guidance

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 Engineers from CIPET, they can apply. 2. Immediate Joiners Preferred. Roles & Responsibilities: 1. Ensure smooth shift changeovers and provide proper handover. 2. Prepare and maintain daily production reports. 3. Manage shift manpower efficiently and ensure proper utilization. 4. Train workers on production procedures and safety protocols. 5. Monitor and reduce production rejections through corrective actions. 6. Implement and maintain 5S practices across the production floor. 7. Ensure plant housekeeping and machine cleanliness is up to standard. 8. Oversee mold loading and unloading activities as per the production plan. 9. Set up machines and initiate jobs as per the defined process parameters. 10.Troubleshoot process and machine-related issues to minimize downtime. 11.Update shift-wise reports and ensure correct labeling of products on each machine. 12.Monitor product weight consistency and act immediately in case of deviations. 13.Verify material availability and correct usage at machines. 14.Ensure all machine checklists are updated daily. 15.Report machine issues promptly to the maintenance team. 16.Monitor that machines are operating as per the shift production plan. 17.Review production output every two hours and highlight any shortfall or delay to the supervisor. 18.Maintain and update process parameter sheets. 19.Issue finished goods (FG) transfer notes to the store team. 20.Maintain production records and documentation as per ISO, BRC-IOP, GMP, and audit requirements Required Skills: 1. Diploma / B.E. / B.Tech in Mechanical, Plastics, or relevant engineering stream. 2. Having 2 to 5 years of experience in production operations within rigid plastic manufacturing. 3. Strong knowledge of molding machines (Injection, Blow, Stretch Blow, etc.). 4. Good understanding of production planning, process setting, and troubleshooting. 5. Familiarity with ISO, GMP, and BRC-IOP standards.

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 corrective and preventive actions (CAPA). Maintain and review sterility testing records , SOPs, protocols, and reports for accuracy and regulatory compliance. Participate in regulatory inspections and internal audits. Provide training to QC microbiology staff on aseptic techniques, gowning, sterility testing, and contamination control. Ensure microbiological methods are validated and kept up to date per pharmacopeial updates. Maintain inventory and calibration status of microbiology lab equipment used in sterility testing. Review and approve environmental monitoring data related to aseptic processing areas. Preferred candidate profile :- Attention to detail and high level of documentation accuracy. Strong aseptic technique and contamination control awareness. Analytical thinking and sound decision-making in compliance-driven environments. Ability to work independently and in a team. Good communication skills (written and verbal).

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/outsourced workforce attendance and performance. Generate and manage all HR and admin-related MIS reports. Supervise facility management services such as housekeeping, canteen, transport, and security operations. Handle administrative documentation, AMC renewals, gate pass issuance, and visitor management. Ensure proper documentation and implementation of all SOPs, and assist QA during internal and external audits. Ensure that all HR processes (onboarding, training, exit formalities, etc.) are documented in controlled SOPs.

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 members. Qualifications Knowledge Skills

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

Bombay Ortho Industries Private Limited (A wholly owned subsidiary of Alkem MedTech Private Limited) Job Description Overall responsible for conducting all EHS related activities at site and allied business facilities including Ensuring effective implementation of sites Occupational Health, Safety and Environment Policy Ensuring implementation and documentation of Occupational, Health & Safety Management System and elements thereof Ensuring implementation and documentation of Environmental Management System and elements thereof Ensuring compliance with EHS related statutory provisions including Act, Rules, Notifications, Directives etc. including liaison work, renewal of Consents and EHS related permissions, timely filling / submission of annual reports / returns etc. Ensuring compliances w.r.t. Extended Producers Responsibility and ESG related EHS compliances Ensuring operation, maintenance, overall healthiness of Occupational Health, Safety and Fire related systems / facilities and allied documentation Ensuring operation, maintenance, overall healthiness of Environmental Management and Pollution Control related systems / facilities and allied documentation Ensuring necessary actions including facility rounds, conducting assessment / reviews / inspections / audits to address, reduce and control EHSS related risks. Ensuring effective implementation of Incident Management system including incident reduction programs and investigations Conducting EHS related trainings, communication and awareness programs including trainings, drills, interviews, demos, meetings, briefings etc. Ensuring Contractors related EHS Management including Permit to Work system Ensuring 24X7 readiness of facility and documentation (including forms, logs, records, analysis, procedures, reports etc.) w.r.t. EHSS in adherence with statutory norms, standards, applicable policies, cGMP, GDP, GLP and GEP

Should have Knowledge of Documents. Should able to handle skilled/unskilled Labour. Should have knowledge of GMP/GDP Practice & aseptic behaviour. We are looking for pharma background candidate only. Perks and benefits PF Bonus Food

Key Responsibilities: (Quality Executives) Monitor and maintain quality standards across production stages Conduct routine lab tests and ensure product compliance Supervise hygiene, sanitation, and food safety protocols Handle customer complaints and implement corrective actions Maintain all QA documentation and regulatory records Train production staff on quality systems and SOPs Coordinate with production, maintenance, and procurement teams Participate in internal and external audits Key Responsibilities: (Packing & Processing Operator) Operate and monitor dairy processing and packing machinery Ensure correct packaging of milk and milk products as per standards Maintain hygiene and cleanliness of packing area Perform CIP (Clean-in-Place) and COP (Clean-out-of-Place) activities Check packaging material quality and report discrepancies Record batch details, downtime, and production logs Follow SOPs and safety protocols during operations Minimize wastage and optimize packing efficiency Coordinate with quality and maintenance teams for smooth operations Report any machine faults or deviations to supervisors immediately