532 Cgmp Jobs - Page 16

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support a...

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support a...

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support a...

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. ...

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. ...

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support a...

Spica Labs Pvt. Ltd. is hiring QC & QA male candidates with experience in HPLC, UV, IR, GMP, BMR review, SOPs, validation, deviations & regulatory knowledge. Send resumes to: spicalabspvtltd@gmail.com.

Job Overview Head of Engineering & Maintenance- will lead all engineering and maintenance operations for a large-scale API pharmaceutical plant. This role is responsible for ensuring the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. The position requires extensive experience in API manufacturing, including expertise in CGMP, FDA regulations, and managing regulatory audits. Develop and execute maintenance strategies, drive continuous improvement, manage OPEX budgets, and lead a high-performing team to ensure safe, efficient, and compliant plant operations. Key Stakeholders: Internal Production , Supply Chain, Finance, Warehouse, operation excell...

Role & responsibilities The position is responsible for Moisture and Thiomersal estimation and ensuring GMP practices Physical observation of vaccines and diluents Formulation Verification Record maintenance Maintenance of Live and Inactivated FG samples and register Maintenance of Pullet ND samples at R&D in coordination with production Moisture estimation of Live vaccines, stability & record keeping and R&D testing To Fill records & BTR Regarding Moisture Determination RM - pH, viscosity, density, specific gravity, refractive index, LOD, water Egg sampling and record maintenance Maintenance of retain samples of RM Preferred candidate profile Should have technical knowledge in GMP, GLP, ISO...

Role & responsibilities Ensure the compliance of cGMP & EHS. Follow the cGMP requirement with appropriate housekeeping and documentation in manufacturing area. Co-ordination with other department for safe, successful and timely batch execution. Achieving plant production target w.r.t quality and yield. Active involvement in facing quality audits by vendor audit & regulatory audits. Lead from front to ensure safe behaviour / GMP culture on the shop floor. Comply with online documentation with complete data integrity. Undergo safety, quality and operational training & comply with requirement. Maintain housekeeping standard to ensure a clean and safe workplace. Follow the SOP practices. Prepara...

Key Responsibilities: Perform analytical testing and analysis of raw materials, intermediates, and finished pharmaceutical products. Conduct instrumental and wet chemistry techniques, including HPLC, GC, UV-Vis, FTIR, and titrations. Develop and validate analytical methods for new and existing pharmaceutical formulations. Conduct stability studies and ensure proper documentation of results. Maintain and calibrate laboratory instruments and equipment. Prepare and review standard operating procedures (SOPs) for analytical testing and instrument operation. Ensure compliance with cGMP (current Good Manufacturing Practices), ICH guidelines, and other relevant regulatory standards. Support analyti...

Job Title: CSV Analyst (Computer system validation) Location: Hyderabad Exp level: 7-10 Years Work mode : Work from Office Shift Timings: UK Shift Primary Skill: CSV (Computer system validation) Secondary Skill: Pharma IT Quality

Location- Novo Nordisk Global Business Services (GBS), Ahmedabad, India Department- GCM Operations Drug Product Are you ready to take charge and make a difference in the pharmaceutical industryIf you’re a dynamic person with a passion for quality and operational efficiency, you might be our new Operations Manager. The position is based in Ahmedabad in India and will report directly to GCM organization based in Denmark. Apply today and get life changing career! Apply now! The position As an Operations Manager, you will be responsible for ensuring Novo Nordisk’s interests with regards to short to midterm capacity, compliance, quality, manufacturing readiness and activities at the CMO. You will...

Role & responsibilities Routine activities of Production department Batch processing CGMP GDP SOP Preferred candidate profile Relevant experience from Pharmaceutical and Chemical industry. Must have cGMP experience.

Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, an...

Strong knowledge of cGMP regulations, quality management systems, and industry best practices. Exposure to international regulatory inspections like USFDA, EDQM. Exposure to international regulatory inspections like USFDA, EDQM Required Candidate profile Bachelor’s degree in pharmacy or master’s degree in chemistry from a recognized university.6-9 years of experience in quality assurance roles within the pharmaceutical or API manufacturing industry.

Experience in pharma regulatory & QMS function, primarily in RLD / comparator sourcing, clinical trial supply chain management, and clinical packaging for USA and EU markets. The role includes supporting the end QMS function and regulatory affairs. Health insurance Provident fund Annual bonus

Role & responsibilities JD- Designation: Deputy manager Department: QA Role: vendor qualification Experience:6-10 years of relevant experience. 1)Preparation and Review of procedures related to Vendor management as per regulatory requirements. 2. Review of QMS elements like Change management (Change control), Deviation, CAPA, related to external testing laboratories, service providers. 4. Management of vendor qualification (Related to Contract services/ contract Labs /CMO) documentation i.e. initiation of vendor assessment, tracking of their audit and periodic monitoring. 5. Responsible for vendor Audit Schedule, Execution of site audit for Contract Testing Laboratories, Contract Service Pro...

Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. : Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with intern...

Review DCS alarms. Ensure that batch charging and other manufacturing operations are strictly in accordance with the BMR/SOP and align with current GMP practices. Maintain manufacturing records online, ensuring compliance with data integrity practices. Collect samples of intermediate/in-process materials and send them to the IPQC/QC lab. Enter and verify production-related inputs in the SAP system. Review and ensure the generation of PISCADA reports. Transfer finished goods using the "Finished Goods Transfer Note." Monitor and ensure minimum stock levels of consumables, logbooks, and status labels. Ensure preventive maintenance of all equipment according to the schedule. Coordinate with serv...

To handle DCS as operator. Ensure batch charging & other manufacturing operations should be strictly as per BMR/SOP & in line with current GMP practices. To maintain manufacturing records online & should comply data integrity practices. To take out sample of intermediate/in-process material and send to IPQC/QC lab. To ensure the production related inputs in SAP system. To be check and ensure the PISCADA reports generation & review of DCS alarms. Transfer finished goods through Finished Goods Transfer Note. To Check and ensure minimum stock of consumables, Logbooks & status labels. Ensuring preventive maintenance of all equipment as per schedule. Co-ordinate with service departments (QA, QC, ...

Lead research and development of APIs, excipients, and formulations. Optimize existing formulations and explore new product ideas. Conduct laboratory research, testing, and documentation. Collaborate with QC, production, and regulatory teams. Required Candidate profile Min 10 years of R&D experience in the pharmaceutical sector. Strong knowledge of formulation science, GMP, and regulatory norms. Skilled in analytical techniques, lab procedures, and instrumentation.

Roles and Responsibilities Prepare and review batch manufacturing records (BMR) and batch processing documents to ensure compliance with regulatory requirements. Monitor production processes to identify areas for improvement and implement changes to optimize efficiency and productivity. Collaborate with cross-functional teams to resolve issues related to product quality, process optimization, and equipment maintenance. Ensure adherence to cGMP guidelines throughout the production cycle.

Responsible to monitor operations in granulation, blending area, compression, coating and tablet inspection area. Responsible to manufacture and ensure quality of the product at respective processing area. Responsible to follow all regulatory/cGMP/Statutory/Company policies are followed in manufacturing area. Responsible for online documentation with real time data. Responsible to participate in equipment qualification and process validation activities Preferred skills : Granulation, Compression, coating and packing of & Exposure in OSDs

Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : LIMS, GMP, cGMP, Starlims, Labware Lims, Labvantage. The opportunity Were looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. Gather and analyse business requirements related to LIMS functionality and enhancements. Analy...