1019 Cgmp Jobs - Page 2

Skills Required: Graduate / PG in management With a minimum of 4 7 years of experience in managing the Admin function. Must have hands on experience into Advance Excel Key Responsibilities Making MIS Reports of collated data Meticulously working on the data collated from various sources of department and preparing comprehensive reports Ensuring the precision of the reports Preparing Delivery Files Extensive work on Excel Preparing necessary dashboards for day to day operations Monitor & analyses data for business trends & prepare monthly revenue & collection report Provide cross functional quality oversight from a compliance perspective fo testing and disposition, quality investigations, val...

Responsibilities: * Conduct research on organic compounds following ICH guidelines. * Develop new products through organic synthesis under CGMP principles. * Collaborate with cross-functional teams to optimize processes. Office cab/shuttle Provident fund

experience in Vaccine or Biosimilar manufacturing Strong exposure to In-Process Quality Assurance & Quality Management Systems and review system Knowledge of GMP guidelines and documentation practices fast-paced, regulated environment Perks and benefits 5- days working, Pf , health insurance

Responsibilities: Schedule daily production and Manufacturing work centres based on sales priorities and material availability. Resource Management To assist production head to qualify manufacturing work stations and resources. Establish and maintain quality standards for all products. strickly adhere the product and in process quality standards on shop floor Ensure compliance with cGMP guidelines to maintain production and quality standards. Documentation ( all statutory and internals) are upto date on day to day basis Supervise. Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and plant housekeeping on a daily basis while ensuring proper record maintenance. Required Ski...

Job Title: Senior Officer – Process Engineering Business Unit: Sun Global Operation Job Grade G12B Location : Gangtok At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: Execution of Breakdown ma...

Responsible for executing and involving in plant activities. Update the documents likes Batch Manufacturing record, equipment cleaning record, daily checklist in online. Follow the standard operating procedure while performing the activities. Follow the In-charge instructions and execute the batches as per production plan. Before starting the batch, ensure the raw materials quantity availability and the packing intactness. Before the process ensure the equipment conditions to inline the operating procedure and process requirements. Any discrepancies observed in the process, procedure or safety should be reported immediately to the relevant reporting authority. Coordination with service depar...

Responsibilities: Monitor and verify all shift activities including machine checking, IPQC (dimensional and attribute), FT change, DB change, greaser change, colour change, daily machine performance reports, and process parameters. Implement quality corrections (dimension, moisture, process parameters) to minimize defects and achieve target DAFOE. Ensure process parameters for colour change are adhered to (viscosity, temperature, dip length, dip bath centrality and parallelity, gelatin level). Maintain viscosity norms during variations in weight and viscosity. Perform SCADA monitoring of process parameters and take corrective actions for deviations. Generate and communicate daily shift repor...

Job Responsibilities To ensure Sit Ready for anytime Regulatory Inspection in Compliance to cGMP Norms of Various Regulatory Bodies. To train personnel on cGMP, regulatory expectations, and quality systems to enhance compliance and awareness. To ensure Vendor Qualification activities are conducted as per SOPs, and maintain an up-to-date Approved Vendor List and requalification of Vendor Schedule. To ensure Quality Assurance, Quality Control, Microbiology, Production, Warehouse, Engineering activities are performed in compliance as per current GMP requirement and their effective implementation. Responsible for ensuring QMS elements (Change Control, Deviations, CAPA, OOS, OOT, etc.) are implem...

JOB DETAILS 1.Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling and weighing materials and supplies. 2.Prepares equipment by performing sterile cleaning-in-place (CIP), servicing-in-place (SIP), and cleaning out-of-place (COP); conducting operator inspections; performing preventive maintenance checks 3.Produces requirements by operating and monitoring equipment; observing varying conditions; adjusting equipment controls; calculating concentrations, dilutions, and yields; adhering to aseptic filtering and filing procedures. 4.Maintains safe and clean work environment by following current good manufacturing pr...

Job description: To carry out the manufacturing operations of API/ intermediate processes in the plant as per the standard operating procedure. To monitor the production activities in the plant as per cGMP and applicable Departmental SOPs. Reporting the status of the production batches to the production manager / Shift Incharge. Should be experienced in unit operations like distillation, layer extraction, crystallization, filtration, etc. Train and encourage the Worker and explain and Take out Highest Quality Production, upkeep GMP environment. Perform regular/periodic activities of GMP procedures established in the plant with means of self-audit, self-inspections. Should be able to prepare ...

Job description: To carry out the manufacturing operations of API/ intermediate processes in the plant as per the standard operating procedure. To monitor the production activities in the plant as per cGMP and applicable Departmental SOPs. Reporting the status of the production batches to the production manager / Shift Incharge. Should be experienced in unit operations like distillation, layer extraction, crystallization, filtration, etc. Train and encourage the Worker and explain and Take out Highest Quality Production, upkeep GMP environment. Perform regular/periodic activities of GMP procedures established in the plant with means of self-audit, self-inspections. Should be able to prepare ...

Project Engineer (PEB) - High Voltage Products Breakers/disconnectors and switches Manufacturing Plant projects Summary This role is responsible for coordination all on-site PEB construction works activities in alignment with project delivery schedule/activities to assure cost-effective execution of project deliverables in accordance with contract specifications, quality standards, schedule, and safety requirements. Job Description About the Role: Review and verify PEB designs including general arrangement drawings, structural calculations, connection details, and fabrication drawings. Coordinate with PEB vendors and consultants to align structural design with pharmaceutical layout, HVAC sys...

Responsibilities: Operate and monitor vial filling, sealing, and washing machines in the injectable section. Ensure aseptic conditions are maintained during all operations in the cleanroom. Perform routine cleaning and sterilization (SIP/CIP) of equipment. Handle line setup, changeover, and minor troubleshooting of filling machines. Record batch manufacturing and equipment log sheets as per GMP guidelines. Follow safety and quality standards as per regulatory requirements (cGMP, WHO, etc.). Coordinate with maintenance and QA for smooth production activities. Required Skills: Logical thinking. Organizing. Good in communication. Required Qualification: - ITI/D.Pharm/B.Pharm

Responsible for Overall site QA compliance activities and drive the organization towards quality improvements Handling of Deviation, Change controls, OOS, OOT and CAPA including investigations and impact assessments

Position: Analyst Quality Control LCMS (Liquid ChromatographyMass Spectrometry) Qualification: M.Sc. in Analytical Chemistry or related field Experience: 1 to 2 years Key Responsibilities: Perform LCMS analysis for routine, stability, and validation samples. Support method development and transfer activities. Maintain instrument calibration logs and documentation. Ensure cGMP, data integrity, and safety compliance. Work in shifts as per laboratory requirements. Skills Required: Hands-on experience in LCMS operation. Attention to detail and accuracy in documentation. Basic understanding of analytical method validation.

Position: Manager Quality Control -LCMS (Liquid ChromatographyMass Spectrometry) Qualification: M.Sc. in Analytical Chemistry or related field Experience: 10-15 years Key Responsibilities: Lead installation and qualification of LCMS instruments. Manage method development, validation, and transfer activities. Supervise routine and non-routine sample analysis using LCMS. Ensure data integrity, cGMP compliance, and documentation accuracy. Review analytical reports, protocols, and SOPs. Coordinate with QA, R&D, and Production for analytical support. Train and guide the team; manage activities across shifts. Participate in internal and external audits and ensure timely closure of observations. Sk...

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 a Senior Manager Production at this company, your role involves overseeing all manufacturing operations to ensure smooth and efficient production processes that meet quality standards. Your responsibilities include: - Planning and coordinating production and packing activities to achieve monthly targets - Reviewing daily production activities for various processes like Granulation, Compression, Coating, Capsule filling, Inspection, Packing, and Nutra section - Ensuring Good Documentation Practices (GDP) at the shop floor and packing area - Coordinating with various departments for smooth functioning of production and packing activities - Handling SAP related work in production - Implement...

As the Special - Quality Operations at Novartis, your role involves overseeing the quality aspects of contract manufacturers for drug product/drug substance/intermediate product/raw material of ADACAP. You will be responsible for ensuring compliance with applicable ADACAP and Novartis standards, quality management systems, and relevant guidelines. Your key responsibilities include: - Developing and maintaining Quality Assurance Agreements with external partners - Qualifying and onboarding contract manufacturers, conducting regular quality risk assessments - Managing activities related to quality processes such as deviations, complaints, recalls, and stability failures - Reviewing third party...

As a Lead Structural Engineer based in Navi Mumbai, you will be responsible for the following key responsibilities: - Hands-on experience in Structural Design activities in Industrial, Pharmaceutical CGMP & FMCG Projects & Semiconductor Projects preferred. - Designing Large Industrial RCC Buildings, Utility Building Shed, Compressor Shelters. - Designing Warehouse and Workshops. - Steel Connection Design including Moment / Shear, Anchor Bolts, Base Plate etc. - Designing FAB shelters for Microelectronics Projects preferred. - Knowledge of Pre Engineered Building (PEB) Structures. - Designing RCC & Steel Pipe Racks and Pipe Bridges, Special Pipe Supports, Steel Platforms. - Designing Tank Fou...

To execute engineering projects related to facility upgrades, equipment installation, and compliance enhancements in alignment with cGMP and USFDA standards. Key Responsibilities Project Execution & Management: Assist in planning, scheduling, and executing engineering projects including new installations, modifications, and expansions. Coordinate with cross-functional teams (Production, QA, QC, EHS) for smooth execution. Ensure timely completion of projects within budget and quality parameters. Compliance & Documentation: Ensure all engineering activities comply with USFDA, cGMP, and other regulatory requirements. Prepare and maintain project documentation including URS, DQ, IQ, OQ, PQ, and ...

Key Responsibilities Responsible for review of stability protocol & report. Responsible for Preparation of Annual Product Quality Review. Responsible for review of Master Packing Card & Master Formula Card. Responsible for preparation and review of Process validation Protocols and reports. Responsible for review of Batch Manufacturing and Batch Packing records Responsible for preparation of batch release certificate and ensuring batch release process performed as per the SOP. Responsible for issuance of Formats, Logbooks, Register, protocol, reports, BMRs and BPRs as per respective procedure. Responsible for review of QC documents such as Specifications and Standard Testing Procedure (RM, bu...

Responsibilities: Supervise daily manufacturing operations for sterile injectable products (vials, ampoules, lyophilized, or PFS). Ensure compliance with cGMP , GDP , and regulatory standards (USFDA, WHO, MHRA). Oversee aseptic operations like compounding, filtration, aseptic filling , and lyophilization . Lead and train production staff in cleanroom behavior and SOP adherence . Maintain accurate batch records , logbooks, and documentation. Handle deviations, CAPA, and support audits and regulatory inspections. Coordinate with QA, QC, and Engineering for smooth production flow. Ensure equipment readiness and proper cleaning/sterilization processes. Required Skills Experience with oncology in...

Responsibilities: Experience in Method Validation. Experience in Stability Study. Experience of review Electronic data review and backup systems. Expert in Qualification of analytical instruments like HPLC, GC, AAS, FTIR, UV etc. Expert in Calibration of analytical instruments like HPLC, GC, AAS, FTIR, UV etc. Must have minimum 3+ years of experience as a Reviewer. Must have an experience of reviewing all types of QC software. Must be familiar with cGMP/GLP practices and ICH and FDA Guidelines. Required Skills Must be excellent in written and spoken English; net savvy and adept at computer skills. Logical thinking. Organizing. Good in communication. Required Qualification: - B.Sc/M.Sc - Chem...

Procurement Operations: Source and procure raw materials (APIs, excipients), packaging materials, and other pharma-related items. Evaluate purchase requisitions and coordinate with internal departments (production, QA/QC, R&D) to ensure timely procurement. Issue purchase orders (POs) and track their status until delivery and GRN. Vendor Management: Identify, evaluate, and develop new suppliers and maintain strong supplier relationships. Negotiate prices, payment terms, delivery schedules, and contracts. Monitor vendor performance based on quality, cost, delivery, and service. Inventory & Cost Control: Coordinate with the inventory team to maintain optimum stock levels. Analyze and control pr...