449 Process Validation Jobs - Page 8

* Opening Position * Sales and Application Engineer Requirements : * BE/ B.Tech/ Dip (Mechanical/ EEE) * 3+ years of relevant industrial product sales experience. * Key skills: Hydraulics, Pneumatics, Electrical actuators, Process Valves * Basic Requirement : Two-wheeler and Laptop * Location: Bangalore, Mumbai, Gujarat, Delhi, Coimbatore, Hyderabad, Chennai. Considerable Profile/ Department: 1. Sales profile with technical knowledge in hydraulics, pneumatics, process valves are highly preferrable. 2. Maintenance profile interested for sales and know basic industrial regions are preferrable. Mandatory Requirement: *Two wheeler, Driving License, Laptop *Key skills Field sales , Pneumatics, Hy...

As a Qualified Person within the Quality department at Piramal Critical Care (PCC) in Haarlem, Netherlands, your primary responsibility will be to certify batches of Medicinal Products before release for sale. This includes ensuring compliance with EU-GMP regulations, relevant EU-directives such as 2001/83/EC and 2011/62/EU, Dutch National Legislations, and overseeing that public service obligations are met. Collaborating with key personnel like heads of production, quality control, quality assurance, and supply chain, you will be responsible for supervising the company's activities to ensure continuous compliance with legal requirements. It is essential for the Qualified Person to be regula...

The ideal candidate for this role will be responsible for updating self-hygiene practices and ensuring adherence to standard operating procedures within the sterile manufacturing department. You will be in charge of preparing, reviewing, revising, controlling, and implementing SOPs, master documents of production, protocols, and reports. Additionally, you will manage documentations like BMRs, BPRs, and master SOPs, as well as handle change control, deviations, CAPA, investigations, and various manufacturing operations such as filling, sealing, labeling, and packing. Furthermore, you will be required to create production planning on a monthly and daily basis, prepare daily production reports,...

You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and clea...

Execution of technology transfer to Sun/CMO Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries. Documentation work like new production introduction form, Scale-up reports, review of Sun/CMO BMR, sampling plan, PV protocol, URS preparation, and Dashboard preparation. To ensure that product is produced and stored according to the appropriate documentation in order to obtain the desired quality. Responsible for Review comments of MF, FMEA, RA protocol (Sampling plan, Process validation protocol) and compliance. 5. Handling Support of Trouble shooting batches for data comparison and route cause Investigation...

Responsible for following activities in purification area of BM/BU based on campaign basis 1. Following GMP, safety practices in production facilities and work place. 2. Responsible for production activities: Execution of area, line clearance before execution of activities. Execution of product changeover activities. Responsible for column cleaning, packing, unpacking, evaluation and maintenance. Responsible for drug substance (FDS) transfer/dispensing. Execution of production activities. Monitoring and review of batch parameters/performance. Ensuring material are arranged properly before activities. Verification of samples for analysis. Responsible for shift Monitoring. Handling of online r...

1.To involve in plasma products manufacturing. 2.Follow shift and production schedules. 3.To complete the assigned trainings timely. 4.To Monitor the differential pressure, temperature and humidity of the classified area. 5.To Ensure the area, equipments cleaning and readiness of equipments for batch activity. 6.Preparation of buffers and other solutions for downstream process. 7.Handling of process related instruments and equipments in downstream process (DSP). 8.Perform all the assigned manufacturing activities as per the defined procedures (SOP, BMR, Protocols) and record the details in respective document. 9.Checking the availability of stock of chemicals, solvents, raw material etc. 10....

1. Follow shift schedule and production schedule as per process requirement. 2.Handling of plasma collection, sanitization, washing, cutting, pooling and thawing. 3.Handling of plasma fractionation process steps. 4.Compliance to all approved procedure, documents and GMP activities. 5.Performing all the assigned manufacturing activities in confirmation to BMR, protocols and recording the details in record sheets and logbooks. 6.In process samples sending to QC for analysis. 7.Performing COP, CIP, PHT and SIP of all the process vessels and equipment. 8.Performing calibration of pH, conductivity meters, turbidity meter, weighing balances and other equipment. 9.Preparation of buffers and other s...

1. Responsible for review of specifications, STPs, GTPs and analytical test data sheets. 2. Review of analytical reports of raw material, packing materials, water samples, product samples, OOT, water trends and ensuring compliance. 3. Responsible to attend the training programs. 4. Responsible for monitoring of quality control Lab (Daily calibration, PMP, Instruments back up data, Excel work sheets lock, user log books). 6. Responsible for handling technology transfer documents. 7. Responsible for review of stability protocols, stability analytical data and summary reports. 8. Responsible for handling of change controls, OOS, OOT, Incidents and investigations. 9. Responsible for compliance o...

1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for operation and handling of Dataloggers, HVAC related equipments. 5. Responsible for compilation and review of validation raw data and test certificates. 6. Responsible for preparation of Installation qualification (IQ), Operational qualification (OQ) and Performance qualification (PQ), revalidation protocols and reports. 7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments. 8. Res...

1. To perform Equipment operation and cleaning. 2. To supervise the Visual inspection and batch packing execution as per plan. 3. To perform the documentation as per Batch record and SOP. 4. To perform the equipment qualification as per protocols and SOP. 5. Responsible to maintain documents as per cGMP norms. 6. Co-ordinate to cross functional team as per day-to-day activities. 7. Responsible for SOP, MPR and BPR preparation and revision. 8. Co-ordination with team to execute daily packing and visual inspection plan. 9. Ensure the training completion before doing activity. 10. To raise batch record request as per plan. 11. Responsible for QMS related activity(Change control, Deviations, Bat...

1. Follow SOPs, GMP and safety practices. 2. Facility Area cleaning, Equipment cleaning, drains cleaning sanitization. 70 % IPA arrangement. Discarding general waste, rejects and biowaste. Log books updation. Spillage management. Updating of BMRs and annexures online. 3. Material Arrangement of plastic / glassware. Material packing for sterilization. Arrangement of garments. Arrangement of materials. 4. Process Arrangement of drums and installation of bags. Collection of WFI. Movement of prepared media/buffer to process rooms. Assisting in cleaning of equipments. Movement of samples. Execution of production activities. Monitoring of batch parameters. Arrangement of HDPE Drums, Vessels and in...

Responsible for production activities Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. Responsible for operation of foll...

Responsible for production activities 1. Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. 2. Chromatography column and resin monitoring. 3. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attachin...

1. Following GMP, safety practices in production facilities and work place. 2. Responsible for production activities: Monitoring of area drains cleaning and documents updation. Updation of area / equipment status labels. Samples handling (Sampling and labelling). Arrangement of material required for activities. Assisting in Execution of production activities. Updation of BMR's. Receiving material (RM miscellaneous). Returning miscellaneous materials to warehouse. Planning and Execution of FDS thawing and dispensing activities. Assisting in product changeover activities before batch execution. Assisting column packing and execution of equipment specific protocols. Assisting in Equipment (Puri...

* Opening Position * Sales and Application Engineer Requirements : * BE/ B.Tech/ Dip (Mechanical/ EEE) * 3+ years of relevant industrial product sales experience. * Key skills: Hydraulics, Pneumatics, Electrical actuators, Process Valves * Basic Requirement : Two-wheeler and Laptop * Location: Bangalore, Mumbai, Gujarat, Delhi, Coimbatore, Hyderabad, Chennai. Considerable Profile/ Department: 1. Sales profile with technical knowledge in hydraulics, pneumatics, process valves are highly preferrable. 2. Maintenance profile interested for sales and know basic industrial regions are preferrable. Mandatory Requirement: *Two wheeler, Driving License, Laptop *Key skills Field sales , Pneumatics, Hy...

Responsibilities: * Ensure compliance with GMP, GLP & BPR review. * Conduct process validation, cleaning verification & change control. * Collaborate on batch manufacturing & release processes. * Prepare SOPs, BMRs & BPRs.

RoleKMIL - Monitoring Requirement2 Gender- Male/ Female both are preferred Education Background- CA / MBA (preference would be MBA- Finance) Experience level - 3 to 5 years (relevant experience not required) Preferred profile- Risk team of retail or wholesale division of any Bank / NBFC. The Key profile of Monitoring & Policy Risk Analyst is to carry out Risk Assessments for Pan India CRE Lending Portfolio is laid down below for your reference . Key responsibilities include Implement effective risk management processes for the Construction Finance business verticals to identify potential risk in the underwritten portfolio and ensure portfolio health Carry out background research and gain a t...

Validation Master Plan (VMP, PVMP, CVMP, QMP) Qualification and Validation Documents and execution BMR, BPR, log book, Protocol, Report and SOP Required Candidate profile Preparation and review of PPQ and cleaning validation protocol monitoring of PPQ and cleaning validation activities To prepare and review (SOP's) and procedures related to validation

Role & responsibilities : Should handle and lead project individually(with help of CFT) through APQP Proficiency in quality core tools like control plan, FMEA problem analysis Expert in MS office well known handling Japanese OEM customers do product validation process validation Homologation testing Preferred candidate profile Immediate joiner

Role & responsibilities To review that all relevant quality management systems of Hosur manufacturing site are implemented and well maintained. To review, monitor and improve Quality performance of Hosur manufacturing site. To promote quality attitude, awareness, and mindset of the site by all proper means including training to the cross functional team members. Implement, audit, and develop quality management system, in line with Global quality policy/ manual and procedures relevant to area. Ensure the required process controls are in place wherever they are necessary. To review that testing and inspection of all raw materials, packaging materials and finished goods are carried out as per d...

Job Title:- KMIL- Wholesale Banking- Risk Monitoring Analyst Grade:- M4/M5 Location:- Mumbai Track financial and project performance covenant: Monitoring financial and project performance against predefined convenants. Identify deviations and promptly communicate findings to relevant stakeholders. Project performance analysis: Conduct through analysis of project performance metrics. Provide insights and recommendations to mitigate risks. Track Compliances to sanctions conditions: Moniotor compliance with sanctions conditions imposed on credit facilities. Take proactive measures to address any non- compliance issue Site Visit: Conduct on site visit to assess the progress and status of project...

As an R&D Executive at VTC R&D, you are responsible for performing and overseeing all activities related to formulation and filling process development. Your duties include having a strong understanding of optimizing vaccine formulations, selecting stabilizers and excipients, as well as preparing adjuvants such as aluminium salts, Oil-In-Water emulsions, Liposome-based adjuvants with TLR agonists and saponin, and LNP formulation. You will also be involved in aseptic filling and Lyophilization cycle designing for new vaccine products and troubleshooting existing vaccines. In this role, you will execute clinical drug product manufacturing for clinical batches, plan and carry out media fill act...

You should have 16-20 years of experience in the pharmaceutical industry and be located in Pithampur. A degree in M.Sc./ M. Pharma / B. Sc. / B Pharma is required for this position. Your responsibilities will include daily planning of analytical activities, resource management, and work allocation. You will be responsible for planning and executing sampling and analysis for raw materials, packaging materials, intermediates, and finished products. You will review and/or approve the implementation of standard operating procedures, analytical protocols, and analytical reports. Additionally, you will review and/or approve the qualification and calibration of instruments. You will investigate and...

As a Pre-Silicon/Post-Silicon Validation Engineer at Mirafra Technologies, you will play a crucial role in validating embedded systems using C or Python. Your responsibilities will include computer system validation, process validation, quality control, and quality assurance. Working closely with design teams, you will ensure that all products meet the required specifications and standards. This is a full-time, on-site position based in Bangalore. To excel in this role, you should have experience in Computer System Validation and Process Validation, along with skills in Quality Control and Quality Assurance. An understanding of the validation process in embedded systems is essential. Profici...