1027 Cgmp Jobs - Page 21

Effective operation and maintenance of equipment like autoclave, Garment cubicle, sealing machine, vessels CIP and SIP SKIDS To practice the c GMP activities and to follow the clean room discipline Cleaning and sterilization of the vessels and transfer lines using CIP & SIP equipment Preparation and filtration of disinfectant and cleaning of the area Monitoring of LAFU, AHU, Dynamic pass box, Garment cubicles and cold rooms Maintaining of all cGMP activities and housekeeping activities in the critical operations Maintenance and updating of equipment log books and GCRs Manual recording of the temperature and positive pressures Cleaning of equipment Blending of vaccines Preparation, Sanitizati...

We are seeking a highly skilled Executive / Sr. Executive Quality Assurance with 8 to 10 years of experience in API / Bulk Drug Manufacturing . The role involves overseeing laboratory incidents, OOS/OOT investigations, analytical method validations, data integrity compliance , and ensuring adherence to GMP and regulatory standards . Key Responsibilities: Handle and review laboratory incidents, OOS (Out of Specification), OOT (Out of Trend), deviations, and root cause investigations . Review and monitor calibration schedules and records for critical analytical instruments (HPLC, GC, UV, IR, AAS, ICP-MS). Oversee analytical method validation, method transfers, and specification reviews in alig...

The Production Chemist will be responsible for executing and monitoring API manufacturing processes, ensuring compliance with cGMP, SOPs, and regulatory guidelines . The role involves operating chemical process equipment, documentation, troubleshooting, and process optimization to achieve efficiency, safety, and quality standards. Key Responsibilities & Duties: Process Execution: Perform batch manufacturing activities in line with Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and cGMP requirements. Equipment Operation: Operate and monitor reactors, centrifuges, multi-mill, shifter, tray dryer, filtration systems, GLR, and SSR equipment . Quality Assurance & Complianc...

Job Title: Sr. Executive Location: Bavla - Plant Department: QA Reporting To: Head of QA Employment Type: Full-Time Key Responsibilities: Prepare and review Cleaning Validation Protocols and Reports , including product matrix and MACO (Maximum Allowable Carry Over) calculations. Develop and execute protocols and reports for Clean Equipment Hold Time and Dirty Equipment Hold Time . Prepare, review, and finalize Process Validation Protocols and summary reports, utilizing analytical results and batch documentation data. Prepare and review Product Hold Time Protocols and Reports to ensure product quality throughout storage. Conduct thorough review of manufacturing documentation, including Master...

Post- Manager - Supply Chain Location Pune Hadapsar , Magarpatta Experience - 08-10 yrs Skills - pharmaceutical supply chain management. Strong understanding of GMP, GDP Education - Bachelor's/Master's degree in Supply Chain Management, Business Administration Job Overview : The Supply Chain Manager oversees and manages the end-to-end supply chain operations, ensuring the timely delivery of pharmaceutical products while maintaining quality, compliance, cost efficiency, and customer satisfaction. JD Develop and implement supply chain strategies Manage warehousing, inventory management, and distribution activities. Ensure compliance with industry regulations and quality standards. Collaborate ...

Maintaining good housekeeping and cGMP in shop floor Preparation of New documents like BPCR and SOP Deviation , change control, OOS, activity and is compliance Plant keeps ready for audit Overall responsibility of cGMP Production should be achieved as per target. Equipment cleaning Log book and Solvent log Book to be maintained. BPCR arrangements for running batches. Review and completion of all documents like BPCR, Equipment logbook, and format as per SOP

Role Overview: As a Research Associate in the API R&D-DBH department, your primary responsibility will be to ensure the smooth and efficient operation of various research activities in the manufacturing blocks. Your role will involve following strict guidelines and procedures to maintain safety, quality, and compliance with cGMP requirements. Key Responsibilities: - Acquire training for each activity/equipment before execution - Follow entry and exit procedures of manufacturing blocks, including chemical and Pharma areas - Perform all process operations as per Batch Manufacturing Records (BMR) - Clean all equipment as per cleaning Standard Operating Procedures (SOP), Procedure, and Process C...

Officer Quality Control - API & Intermediates Education - M.SC - Analytical / Organic Experience 1 to 3 years experience in Quality Control from pharmaceutical industry. (This is a Fixed Term Contract role - On Company's Contract) Job Description - Sampling of raw, packing material, intermediate & finished product. Analysis of raw, packing material, intermediate, stability samples & finished product. Analysis of process & cleaning validation samples. Preparation of standard volumetric solution, reagent & standardization of volumetric solution and check for stability. Inventory of Instruments Spares, Chemicals & Glassware. To maintain cleanliness, personal and environmental safety & follow Go...

To operate and monitor granulation equipment and processes in compliance with cGMP, SOPs, and safety standards, ensuring consistent production of high-quality pharmaceutical granules for tablet or capsule formulation. Key Responsibilities: Operate granulation equipment such as high-shear mixers, fluid bed dryers, oscillating mills, and blenders. Weigh, dispense, and mix raw materials as per batch manufacturing records (BMR). Monitor granulation parameters and adjust settings to maintain product quality. Perform in-process checks (e.g., moisture content, granule size) and document results accurately. Clean and maintain equipment and work areas as per SOPs. Execute machine changeovers and line...

We're Hiring! Location: Bengaluru Role: Medical Domain Labeling & Packaging Document Control Specialist Are you passionate about quality systems and documentation in the medical device industry? Join our team and play a key role in managing labeling databases, regulatory documentation, and packaging specifications. Key Responsibilities: Manage documents in compliance with ISO, cGMP, and FDA guidelines Handle change control via Documentum/IFS/Livelink/MasterControl Complete Engineering Change Requests for Global Labeling & Packaging Track documentation lifecycle and maintain revision control Coordinate stakeholder reviews and approvals Drive continuous improvement initiatives Organize and mai...

Role & responsibilities Position Overview: We are seeking a highly skilled and experienced Senior Engineer in Quality Assurance to join our dynamic team at BiOZEEN. The successful candidate will play a key role in ensuring the highest standards of quality, compliance, and efficiency in our biopharmaceutical equipment qualification used for vaccine manufacturing processes. Job Description: 1) We are looking for an efficient, skilled, creative and experienced Senior Engineer - Quality Assurance to join BiOZEEN. 2) The successful candidate will work closely with the Dy. Manager Quality Assurance to ensure that our products meet quality and regulatory requirements. This includes overseeing and r...

Job Title: Packing Supervisor OSD (USFDA Approved Plant) Job Location: Dadra Job Summary The Packing Supervisor will oversee and manage the packaging operations of oral solid dosage pharmaceutical products in compliance with USFDA, cGMP, and company standards This role ensures timely execution of packing activities, adherence to quality and safety norms, and coordination with cross-functional teams to meet production targets, Key Responsibilities Supervision & Operations Oversee day-to-day packaging operations for OSD products, Ensure compliance with USFDA, cGMP, and SOPs during all packing activities, Monitor and maintain the integrity of batch records and documentation, Quality & Complianc...

Operate and maintain WTP RO UV and softener systems Ensure purified and process water as per pharma standards Perform routine maintenance of pumps valves filters membranes Monitor pH TDS conductivity hardness and microbial load Required Candidate profile Diploma BE in Mechanical Electrical Chemical 2 to 5 yrs exp in WTP RO Softener Pharma Utilities Knowledge of cGMP WHO norms Maintain logs and support GMP WHO

Post Production Operator - Capsules Organization Context Position Title: Line Operator - Capsules Employee Name: Grade : DET Department: Manufacturing-Post Production Location: Aurangabad Reports to: Team lead/Hall In-charge Reported by: Job Objective Maintain line continuity, productivity, quality of product, reduce wastages and adherence to cGMP, GDP and safety in-shift for the allocated line(s). Primary responsibilities Strategic Planning Activities: Core: Check the allocated post production (ATS/Printing /camera)- line(s) in each shift as per the CTQ (critical to Quality) /CTP (Critical to Productivity) checklist Follow plan as per colour change note by ensuring minimal change over time ...

Conduct regular inspections and audits of products, processes, and systems.Identify quality issues and implement corrective actions.Develop and maintain quality documentation, including SOPs and checklists.

B.Sc/M.Sc Chemistry, 1–8 yrs exp in API/Pharma QC. Must handle HPLC/GC/UV/IR, cGMP, stability, and docs. Local preferred Dahej. Only male candidates are required. Only pharma experience required.

Division Department Sub Department 1 Job Purpose Execute the production operations in line with safety and GMP requirements to meet the manufacturing targets in shift. Key Accountabilities (1/6) Operate the equipment efficiently without error and deviation as per SOP to meet shift targets Perform unit operations as per SOP and unit processes as per batch manufacturing record Optimize the utilization of available resources for achieving production in shift Maintain equipment, facility and block premises as per SOP for audit readiness Key Accountabilities (2/6) Provide suggestions for optimization of processes to manufacture quality product Identify the deficiency in area and errors in documen...

As an experienced candidate with 17-20 years of experience, your role as Engineering Department Manager will involve the following responsibilities: - Manage and lead the engineering department at the site, ensuring smooth operations. - Oversee operation and maintenance of HVAC systems and utilities. - Develop, implement, and monitor monthly planners and maintenance schedules. - Ensure readiness of the department for customer and regulatory audits; represent the department during audits. - Implement corrective and preventive actions (CAPA) and monitor their effectiveness. - Monitor and ensure compliance with process equipment and facility maintenance activities in line with cGMP requirements...

Job Responsibilities: Handling and monitoring the process in shifts. Following cGMP and Records updating (BPR, Data record, Machine running hours, Cleaning records) Manpower handling in shifts. Planning of shift activities & monitoring of shift activities. Supporting Pl ant- in-charges to achieve targets as per production plan. To follow ALCOA++ and data integrity procedures as per guidelines. Immediately reporting to plant in charge if any, abnormality noticed during the process and plant in the shift. To adhere cGMP (Q7 guidelines). Coordinating with QA, QC, Services department like electrical and mechanical, stores departments. To ensure good housekeeping and safety of men, material and m...

Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical a...

ensure compliance with cGMP, cGLP, SOPs & regulatory norms. Prepare/review QMS docs (SOPs, CAPA, Deviation, OOS, Complaints). Oversee production, resource planning, validations, in-process checks & documentation (BMR/BPR). Coordinate with QA/QC/

You should have a minimum of 10 to 15 years of experience in the QA department of Pharmaceutical formulation. Your responsibilities will include having knowledge of regulatory requirements and documentation such as water validation, process validation, incident management, change control, CAPA, etc. It is essential for you to be capable of providing training to junior staff. Familiarity with WHO GMP/cGMP is a requirement. The ideal candidate will hold an M.Pharm/B.Pharm/M.Sc. degree.,

As a seasoned professional in the field of pharmaceutical sciences, you will be responsible for providing technical expertise, strategic leadership, project management, regulatory compliance, and team development in the realm of liposomal drug products. Your primary focus will be on guiding formulation design, optimizing processes, and ensuring adherence to global regulatory requirements for liposomal generics. Utilizing a science-driven approach, you will tackle complex challenges in formulation and manufacturing to drive project success. Leading and managing R&D projects centered on liposomal formulations will be a key aspect of your role, aligning these initiatives with organizational goa...

As a QA Manager at Systacare, a trusted name in the pharmaceutical industry, your primary responsibility will be to ensure adherence to regulatory requirements and maintain the highest standards of compliance in injectable manufacturing. With a strong focus on innovation, compliance, and patient safety, Systacare is expanding its team and is seeking passionate professionals to join the organization. You will lead and manage the QA team to ensure compliance with cGMP, regulatory standards, and company SOPs. Your role will involve overseeing quality systems, including deviation management, change control, CAPA, OOS, and OOT investigations. It will be crucial for you to ensure quality assurance...

As a member of the Group Company's Capsules team, your primary responsibilities will include checking the allocated post production (ATS/Printing/camera) line(s) in each shift according to the CTQ (critical to Quality) / CTP (Critical to Productivity) checklist. You will be required to follow the plan for color change noted, ensuring minimal change over time at each subsection. It is essential to follow instructions from the shift lead to facilitate timely changeover by ensuring the availability of rollers/ink, etc. You will execute IPQC after every roller cleaning, checking rejections of cameras every hour to achieve zero defects. Operating cameras as per SOP to meet productivity and qualit...