245 Deviation Jobs - Page 5

Job Description :- Maintenance Officer / Sr. Officer Scicore Nutra Private Limited is a state-of-the-art facility, located in Sanand Gujarat, is dedicated to producing high-quality nutrition products that are safe, effective, and meet the highest standards of quality. Our team of experts is committed to ensuring that every product we manufacture is produced with the utmost care and attention to detail. At our manufacturing unit, we use only the best raw materials and employ advanced manufacturing processes to ensure that our products are of the highest quality. We also adhere to strict quality control measures to ensure that every product meets our rigorous standards. This starts with doing ...

About: Sahajanand Medical Division Medical division is approved by state and central licensing authorities and it delivers efficient performance to meet specific requirements. The SLTL brand stents embody that bold spirit, offering a unique blend of our leading-edge technologies and time-tested engineering With Technical Collaboration & Patent Design, the company started indigenous manufacturing of Coronary products, in 2009. The company has a dedicated in-house R&D department approved by DSIR (Department of Scientific and Industrial Research). We believe that every product we make should stand for something. Something more than expected. And thats why we dont manufacture products for stereo...

Greetings from HCL! Currently Hiring for "Compliance" JD: Stakeholder Management Excellent Oral and Written communication. Extensive experience in directly working with customers Periodic Review Hands on experience in conducting Application Periodic Reviews Manage Periodic review processes including scheduling, conducting and reporting of Periodic reviews Documenting process gaps and working with stakeholders to rectify them Experience in analyzing risks and working with stakeholders for mitigations Deviation Performs Deviation Creator role and maintains the Deviation lifecycle and creates identified Deviations as a Deviation record in QMS system Collaborates with multiple stakeholders in re...

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...

Handling of Document issuance, BMR / BPR issuance, Change control, deviation, Control (Retain) Sample management, SOP issuance/ Document archival and retrieval, Issuance Management of Doc Cell., Internal audit activities,

Role & responsibilities (Production): Assist in manufacturing operations of parenteral dosage forms (sterile injections) as per SOPs and GMP guidelines. Monitor and record process parameters during manufacturing and filling operations. Ensure compliance to cGMP, documentation and data integrity norms. Support continuous improvement initiatives in production efficiency and compliance. Role & responsibilities (Engineering): Assist in preventive maintenance and breakdown handling of production equipment Support engineering team in equipment qualification and calibration activities. Monitor Utility systems Maintain proper documentation as per GMP norms. Follow safety protocols and support new in...

Role & responsibilities Incharge for QMS activities, Preferred candidate profile Should have good knoledge about QMS, Validation, calibration , qualification, re-qualification, change control. CAPA, OOS, OOT & Investigation. Mainly for all Process equipments and Utility ( HVAC System, Purified System, Refrigerator System, Air Compressor System & Boiler ) Exposure with Regulatory Aduits.

Responsibilities: * Implement Change Control procedures during deviations/CAPAs. * Conduct BPR reviews, BMR analysis, GMP compliance checks. * Ensure product quality through process validation and CAPA implementation.

Responsible for the Investigation of customer complaints received from telecollections via RTS. Job Responsibility Investigation of assigned customer complaints Root cause analysis of complaints and suggest corrective actions Primary contact for all customer experience reporting and complaint handling activities This individual is responsible for independently receiving, documenting, investigating, and coordinating responses on all complaints. Ensures timely investigation of and response to all complaints. This involves initiating and participating in investigations and corrective action arising from complaints. Maintains current and complete complaint files. Performs analyses of complaints ...

Candidate should be able to achieve the organizational goal in maintaining the Quality Management system of API industry. He should be able to execute various function QMS like CAPA, Deviation, CC, Risk assessment ETC Candidate Profile: Should have minimum Two years experience. He should be able to work with the team and be willing to take initiative & challenge for completing the task timely

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The m...

-Check documents like packing sheets, Temp Records, Logger readings -Exp with CAPA documentation -Monitor & maintain the temperature systems -Provide training & prepare training records -Branch visit & perform self inspection activity for branches Required Candidate profile -Male/Female willing to travel (PAN INDIA) -Exp in food/pharma industry preferred -Exp in CAPA documentation is a MUST -Excellent verbal and written communication skills Perks and benefits PF, ESI, Mediclaim, Bonus, PL

The Deputy Manager - Quality Management System (QMS) is responsible for overseeing and ensuring the effective implementation, maintenance, and improvement of the Quality Management System within the PCC Digwal. The role involves meticulous management of documentation, adherence to regulatory requirements, and proactive involvement in quality-related processes. Key Responsibilities: Key Responsibilities: 1. Manage the ENSUR system for issuance and retrieval of SOPs, specifications, ATRA, worksheets, stability protocols, BMRs, BPRs, BFRs, etc., as per requirements. 2. Ensure adherence to document control procedures, including archival, retention, and destruction of documents as defined in the ...

The primary responsibility of this role is to conduct market research to gain insights into the requirements for new product development. You will be tasked with identifying the needs of the company and utilizing market research to define the objectives and needs of new products. Utilizing CAD software, such as AutoCAD, SolidWorks & CATIA, you will be responsible for conceptualizing new product ideas and designing prototypes. The role also involves creating 2D and 3D drawing specifications based on the specific requirements. A good understanding of Sheet Metal material manufacturing processes like CNG, Bending, Welding, Cutting & Assembly is essential for this position. You will also need to...

Roles and Responsibilities Maintain accurate records of all quality-related activities and reports. Conduct quality audits, internal audits, BMR review, capa, change control, GMP compliance, deviation management. Ensure adherence to cGMP guidelines during production runs. Identify areas for improvement through continuous monitoring of processes and implement corrective actions. Collaborate with cross-functional teams to resolve quality issues and improve overall productivity. Document issuance (i.e., Batch Manufacturing Record , Lab Note Book, Log books, analytical work sheets, SOP formats etc.,) Review of executed documents (e.g., Batch Manufacturing Record, analytical work sheets Equipment...

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...

Long Description 1 Exposure of execution of planning of Inprocess, Finished product, stability and cleaning validation samples of MDI / DPI formulation. 2 Exposure of compliance to all cGMP, GxP or any other regulatory requirements, including EHS requirements. 3 Maintenance of GLP in the Laboratory. 4 Having knowledge of Analytical Instruments like HPLC, GC, GCMS, LCMS, UV, IR, KF, ACI, NGI, DUSA, Spray Pattern etc. 5 Exposure of Laboratory investigation like OOS, OOT, Incidence, Deviation, CAPA, Change control etc. 6 Exposure of Stability sample management & Regulatory Audits. 7 Exposure of Analytical method transfer, Analytical method validation / Verification activity. 8 Exposure of Calib...

Witnessing of manufacturing processes for sterile drug products including cleaning, sanitization, environmental monitoring and personnel monitoring to ensure compliance with CGMP regulations and regulatory standards Oversight of cleanroom behavior, contamination control and aseptic techniques To report any observations to site operations and quality and ensure compliance to the observations Review of media fill protocol and reports and witnessing aseptic process simulations Review of batch documentation to ensure product quality, regulatory compliance and meeting ALCOA++ requirements Review of environmental monitoring reports Review of unplanned deviations and CAPA

Witnessing of manufacturing process (mixing, granulation, blending, compression, coating, capsule filling) & packing (primary/secondary packaging) for solid oral products to ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory expectations. Oversight of line clearance, equipment and area cleanliness, material verification, and adherence to SOPs. Ensure compliance with data integrity (ALCOA++) standards in all documentation and records related to production and QA oversight. Review of batch documentation to ensure product quality and regulatory compliance. Review of unplanned deviations and CAPA. Review of environmental monitoring data Collaborate with site operat...

Long Description Role- Shift Officer - MDI Manufacturing To Supervise compliance to all CGMP or any other regulatory requirements, including EH&S requirements. Complete self-training and monitor training of team members on relevant SOP. Report any quality concerns or suggestion for improvements SOPs. Execute and supervise all tasks and activities as per the applicable SOPs. Supervision of operations, cleaning and maintenance of MDI process equipment's / area in MDI Production area of unit-3. Planning, execution, monitoring supervision of all unit operation for batch processing and Manufacturing. Co-ordination with cross-functional teams for smooth execution of production plan at shop floor. ...

Long Description Annual maintenance contract preparation and preventive maintenance of QC instrument as per approved procedure. Breakdown handling of QC instrument as per approved procedure. Upkeep the records for preventive maintenance and breakdown in SAP. Qualification of New instruments with complete documentation. To participate in failure investigations related to instrument malfunctions. To impart training to the analysts for instrument maintenance and troubleshooting. Co-ordination with service engineer for service/ breakdown related activities To maintain good laboratory practices and discipline in respective work area. Actively taking part in cGMP, training and SOP training as and ...

Key Responsibilities Process Improvement & Automation Identify repetitive and manual processes ripe for automation across reporting, documentation, and administrative workflows Lead initiatives to streamline operational tasks and improve capacity management Collaborate with cross-functional teams to implement scalable efficiency solutions Reporting & Analytics Own monthly reporting cycles, including dashboards, benchmarking, and methodology-based tracking Proactively refine reporting methods for better transparency and time savings Document & Site Management Maintain and manage SharePoint and Sphere sites, including user permissions, file structures, and content consistency Support migration...

BMR Review, BPR Review, Line Clearance, Change Control, Deviation.

Role & responsibilities :- Hands on experience for BMR, Process validation report, Stability Protocol, Sampling Plan, Knowledge about GDP initiation and closure of Change control, deviation in GMP. Having good knowledge of guidelines SUPAC, cGMP, Compliance, ICH Q1A,Q2,Q7, Q8,Q9, A10, Q13. Knowledge about GAP assessment between sending unit and receiving unit equipment / instrument / documents. Hands on experience with Advanced Microsoft Word, Power point and excel Effective communication and Co-ordination with CFT. Sound Scale up/down knowledge Calculation, forecasting, Risk assessment etc. Plan Lab scale experiments and perform. Preferred candidate profile :- Must Have Experience in Tech T...

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.