Dahej, Gujarat, India · On-site
Take complete responsibility for API manufacturing operations during the assigned shift. Execute production batches as per approved BMRs, SOPs, and validated process parameters. Monitor and control critical process param…
Skills: API Manufacturing, cGMP Compliance, BMR Review, SOP Adherence, Process Parameter Monitoring
Udaipur, Rajasthan, India · On-site
To maintain proper hygienic condition before entering to parenteral manufacturing area. To follow manufacturing area entry exit procedure properly. To take part in training whenever necessary. To perform the cleaning act…
Skills: Parenteral manufacturing, GMP compliance, Equipment operation, Vial washing, Lyophilization
Udaipur, Rajasthan, India · On-site
Major purpose of the job : • Perform EHS functions pertaining to development and implementation of safe working atmosphere to avoid any injury/occupational illness, Environment management system with fulfilling legal req…
Skills: EHS Management, Effluent Treatment Plant, Sewage Treatment Plant, Hazardous Waste Management, Environmental Compliance
Dahej, Gujarat, India · On-site
Execute API manufacturing processes as per approved Batch Manufacturing Records (BMRs), SOPs, and standard procedures. Monitor and control manufacturing operations such as charging, reaction, heating/cooling, distillatio…
Skills: API Manufacturing, Batch Manufacturing Records, GMP, SOP Compliance, Process Monitoring
Udaipur, Rajasthan, India · On-site
Major Purpose of the Job : Management of stores activities for Raw Materials, Packing Materials and Finished goods storage, Dispensing & Dispatch of Raw materials and Finished goods. Training of the staff / workmen at th…
Skills: Inventory Management, SAP, cGMP Compliance, Warehouse Operations, Supply Chain Coordination
Dahej, Gujarat, India · On-site
Support monthly, quarterly, and annual sales and revenue planning for the API portfolio. Track sales targets, actual sales, order bookings, dispatches, and outstanding orders. Coordinate with customers regarding enquirie…
Skills: Sales Planning, Revenue Planning, API Portfolio Management, Business Development, Market Analysis
Dahej, Gujarat, India · On-site
Take complete responsibility for API manufacturing operations during the assigned shift. Execute production batches as per approved BMRs, SOPs, and validated process parameters. Monitor and control critical process param…
Skills: API Manufacturing, Production Management, cGMP Compliance, SOP Adherence, Batch Manufacturing Records
Dahej, Gujarat, India · On-site
Install electrical wiring, outlets, switches, lighting, and electrical panels. Inspect electrical systems to identify faults or safety hazards. Repair and replace defective wiring, fixtures, and electrical equipment. Rea…
Skills: Electrical wiring, Circuit testing, Troubleshooting, Blueprint reading, Preventive maintenance
Dahej, Gujarat, India · On-site
Perform preventive, predictive, and breakdown maintenance of process and utility equipment. Ensure minimum equipment downtime and maximum plant availability. Diagnose equipment failures and implement corrective and preve…
Skills: Preventive maintenance, Predictive maintenance, Equipment troubleshooting, Process equipment maintenance, Utility equipment maintenance
Udaipur, Rajasthan, India · On-site
To maintain proper hygienic condition before entering to manufacturing area. To follow manufacturing area entry exit procedure properly. To take part in training whenever necessary. To perform area cleaning as per SOP an…
Skills: cGMP Compliance, SOP Adherence, Equipment Operation, Filter Integrity Testing, Particle Monitoring
Udaipur, Rajasthan, India · On-site
To maintain proper hygienic condition before entering to manufacturing area. To follow manufacturing area entry exit procedure properly. To take part in training whenever necessary. Preparation of Disinfectant solution a…
Skills: Aseptic Processing, cGMP Compliance, Equipment Operation, In-process Checks, Documentation Practice
Udaipur, Rajasthan, India · On-site
To ensure proper hygienic condition of workmen before entering to packing area. To ensure packing area entry exit procedure is properly followed by workmen. To ensure packing area equipment are operated as per SOP To ens…
Skills: cGMP Compliance, SOP Development, Quality Assurance, Equipment Qualification, Documentation Practices
Dahej, Gujarat, India · On-site
Perform routine QA oversight during API manufacturing operations. Conduct line clearance before batch initiation and product changeovers. Ensure adherence to cGMP, GDP, SOPs, BMR/BPR, and regulatory guidelines. Verify co…
Skills: QA Oversight, API Manufacturing, Line Clearance, cGMP, GDP
Dahej, Gujarat, India · On-site
Execute batch manufacturing activities as per Batch Manufacturing Record (BMR), SOPs, and approved process parameters. Operate and monitor reactors, centrifuges, ANFD, dryers, filters, and associated equipment. Perform r…
Skills: Batch Manufacturing, SOP Compliance, Reactor Operation, Centrifuge Operation, ANFD Operation
Dahej, Gujarat, India · On-site
Timely validation of all instruments in laboratory. All documents required for Regulatory compliance are maintained properly. To report any OOS/incidents/deviation discrepancy in laboratory analyst to section in charge/Q…
Skills: Instrument Validation, Regulatory Compliance, OOS Reporting, STP Preparation, SOP Implementation
Mississauga, Ontario, Canada · On-site
$40k–$50k/yr
Job Type: Current Vacancy WHO WE ARE: At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and semi-solid pharmaceu…
Skills: Laboratory support, Inventory management, Glassware maintenance, GDP documentation, GMP compliance
Gujarat, India · On-site
Principal Tasks &Responsibilities Safety : • Ensure and follow all the safety system and procedure in place and all the people trained to achieve zero incident and accident. Quality : • Ensure and follow all the current …
Skills: Production Planning, cGMP Compliance, People Management, Regulatory Audit Readiness, Supply Chain Coordination
Dahej, Gujarat, India · On-site
Execute preventive maintenance schedules as per annual maintenance plans. Coordinate planned shutdowns and maintenance activities with Production and Utilities. Ensure timely closure of maintenance work orders through SA…
Skills: Preventive Maintenance, SAP PM, CMMS, Equipment Troubleshooting, Mechanical Alignment
Dahej, Gujarat, India · On-site
Job Summary The Quality Control Officer will be responsible for performing routine and stability analysis of Active Pharmaceutical Ingredients (APIs) using analytical instruments such as HPLC and GC while ensuring compli…
Skills: HPLC, GC, Quality Control, cGMP, GLP
Dahej, Gujarat, India · On-site
Execute preventive, predictive, and breakdown maintenance of process and utility instruments. Ensure maximum uptime of instrumentation systems to support uninterrupted production. Perform troubleshooting of field instrum…
Skills: Preventive Maintenance, Predictive Maintenance, Troubleshooting, PLC, DCS
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The Assistant Manager is responsible for overseeing API manufacturing operations, ensuring all production batches comply with cGMP, SOPs, and BMR requirements. They must monitor critical process parameters, manage equipment performance, and lead investigations into deviations or batch failures.
The role requires extensive experience in API manufacturing and a deep understanding of regulatory compliance and quality standards. Candidates must be proficient in supervising complex chemical processing equipment and managing production documentation.
Take complete responsibility for API manufacturing operations during the assigned shift.
Execute production batches as per approved BMRs, SOPs, and validated process parameters.
Monitor and control critical process parameters such as:
Temperature
Pressure
Vacuum
pH
Agitation
Addition rate
Reaction time
Drying parameters
Supervise operations including charging, reaction, heating/cooling, extraction, filtration, centrifugation, distillation, solvent recovery, drying, milling, and packing, as applicable.
Ensure batches are completed within the approved cycle time and production schedule.
Ensure all manufacturing activities are performed in compliance with cGMP, SOPs, BMRs, GDP, and data-integrity requirements.
Review and ensure proper completion of BMRs, equipment logbooks, cleaning records, and shift records.
Ensure proper line clearance, equipment status labeling, area clearance, and cleaning verification.
Deviations
Process abnormalities
Yield variations
Equipment failures
Batch failures
Support OOS/OOT, deviation, CAPA, change-control, and investigation activities wherever applicable.
Ensure production records are complete, accurate, and available for QA review.
Supervise operation of API manufacturing equipment such as:
Reactors
Centrifuges
Nutsche filters / Filter dryers
Vacuum/agitated dryers
Distillation systems
Solvent recovery systems
Milling and sieving equipment
Identify equipment abnormalities and coordinate with Engineering for timely resolution.
Monitor equipment utilization and minimize production downtime.
Ensure equipment is properly cleaned, labeled, and released before use.
Support equipment qualification and process-validation activities as required.
Dedicated To Making It Better
CPL is a leading contract development and manufacturing organization (CDMO) that provides development, manufacturing, packaging, and testing of non-sterile liquid and semi-solid pharmaceutical and regulated OTC products. We have two facilities located in Mississauga, Ontario, Canada including our manufacturing & development site and our QC/office site. Our site segregation and controls allow for the handling and processing of many specialized materials including flammable materials, light or oxygen sensitivity, and hormones. Our facilities are registered with the FDA and Health Canada and are routinely audited by regulatory agencies as well as our customers. By offering a full-spectrum partnership – from development to commercial production – CPL creates strategic relationships with our customers that creates mutual benefits.
Offices: 7600 Danbro Crescent, Mississauga, Ontario L5N 6L6, CA
Dedicated To Making It Better
CPL is a leading contract development and manufacturing organization (CDMO) that provides development, manufacturing, packaging, and testing of non-sterile liquid and semi-solid pharmaceutical and regulated OTC products. We have two facilities located in Mississauga, Ontario, Canada including our manufacturing & development site and our QC/office site. Our site segregation and controls allow for the handling and processing of many specialized materials including flammable materials, light or oxygen sensitivity, and hormones. Our facilities are registered with the FDA and Health Canada and are routinely audited by regulatory agencies as well as our customers. By offering a full-spectrum partnership – from development to commercial production – CPL creates strategic relationships with our customers that creates mutual benefits.
Offices: 7600 Danbro Crescent, Mississauga, Ontario L5N 6L6, CA
