335 Deviation Jobs - Page 12

Sr. Executive AM- Hot Refining: CMR GreenTechnologies Limited CMR Group is India's largest producer ofAluminium and zinc die-casting alloys. With 13 state-of-the-art manufacturingplants across the country, CMR has become the preferred supplier for many ofIndias largest automotive industry leaders. Since its inception in 2006, CMRhas consistently outpaced competition by focusing on delivering superior valueto its stakeholders. This value is driven by a strong commitment to technicaladvancements, quality enhancement, sustainability, and people-centric practices.We believe in an " Employee First " philosophy, ensuring that our people are at the core of our success. Our dedication tofostering an...

Bachelor's degree with over 10 years of experience in designing and developing solutions in Trackwise. Experience working in a GMP environment, 7+ years in an IT Systems Role. Expert knowledge of GMP Quality Management to include CAPA/Deviation, Lab Exception, Product Complaint, Audit, and Supplier Management. SDLC/GAMP, Business Analysis, and Enterprise Systems Management. General knowledge of GxP Quality Processes and Systems (GMP, GLP, GCP, GVP, GDP) Demonstrated experience leading teams in the implementation of Trackwise and QMS solutions, ensuring alignment with business objectives and compliance requirements. Comprehensive understanding of Quality Management processes, regulatory compl...

Raw Material Inspection. Like Boards, Kraft, Liner, Adhesive, Coating, Film, Etc (Sampling, Testing, Reporting & Recording) In-Process Checking (Printing & Post printing) COA (Certificate of Analysis) making. Lab Instruments Calibration Required Candidate profile Customer Specification Analysis & Comparison Against Actual. Job Traceability (Forward & Backward) Creating Job file like Artwork, KLD, shade card, approved Dummy and Inspected incoming raw materials. Perks and benefits Accommodation, PF, ESI, Bonus

To involve from start and investigate level 2 & 3 incidents, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To Involve in valid OOS and other cases as relevant, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To review level 1B incidents and give feedback for improvement. To periodically trend level 1A incidents and highlight/escalate key observations. To review any other referred reports associated with incidents/events in association with sites. To possess high level of integrity to have unbiased, independent and objective closure of incidents and m...

Role & responsibilities Min 5 years experience into API Pharma background Should handle the Change controls, Deviations, CAPAs of utility & HVAC systems SOP preparations, SOP revisions of utility/HVACs Should be able to handle customer & regulatory audits Having good knowledge in HVAC operations/Breakdown Should have knowledge in HVAC validations Kindly share profiles with job title on gaurangikudavkar@lupin.com

JD: 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per seniors guidance. 5) To be prepare cleaning validation protocol and report as per seniors guidance. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPC...

Retrival& Issuance of documentation GDP CGMP Control Documents Dispatch verification Batch Manufacturing

Job Title: Executive / Sr. Executive / Assistant Manager / Deputy Manager Production QMS (OSD) Work Location: Naidupeta, Tirupati District, Andhra Pradesh Experience Required: 3 15 years (must be from an OSD plant) Qualification • B.Pharm / M.Pharm Key Responsibilities • Own and update Production SOPs, BMR/BPRs, logbooks, and work instructions in line with cGMP and regulatory guidelines (US FDA, MHRA, EU, WHO, etc.) • Coordinate and investigate deviations, OOS/OOT, incidents, and execute effective CAPA & change-control activities • Perform risk assessments (FMEA/RA) for new processes, equipment, and layout changes • Conduct shop-floor audits, line clearance, and data-integrity checks; ensure...

Greetings for day. We are having opening for the role Manager - QMS & Documentation Management in Corporate Quality Department. Department : Corporate Quality Location : Mumbai - Andheri East Qualification - B. Pharm. / M. Pharm / M. Sc. Industry Preferred : Pharmaceutical. Work Experience :12 - 18 years Corporate Experience only. Job Description : Quality Management System (QMS) Oversight: Ensure robust implementation and periodic / Retrospective review of all QMS elements including Change Control, Deviation, CAPA, Risk Management, and Quality Review. Documentation Lifecycle Management: Coordinate periodic SOP revision cycles. Ensure alignment with current practices, regulations, and audit ...

Responsibilities: Review of formulation development documents like trade dress for new product, feasibility report, justification for specification, scientific study protocol and report and pharmaceutical development report. Health insurance Provident fund

Handling, storage and retrieval of all the documents pertaining to facility on operation of the functional departments. Deploying Good Documentation Practices throughout all the functions. Allotment of reference numbers, Formatting, distribution, control, revision, retrieval and storage of all master documents. Maintaining of master list of documents. Maintaining online documentation. Issuance of Formats, LNBs & Log books to all departments. Preparation of QA&RA SOPs. Monitoring of Instruments and Equipment calibrations. To involve internal quality and regulatory compliance audits across all the functions. Handling of Training Records across all the functional departments. Monitoring for com...

1. Operations Undertake co-ordination with field people from CCR for smooth operation of the plant Measure various process parameters along with Shift In-charge. Record process parameters and plant log for the respective section, inspect specific parameters on regular basis, and perform any extra duties assigned by the Shift In-Charge Monitor the quality of the products- Raw meal, Clinker and Cement- and maintain the quality within the range as defined in the QMS procedures Keep good co-ordination with the laboratory for the feedback of quality follow the non-conformity procedure in case the product is not conforming to the standards Executes, according to the safety procedures, the necessar...

Long Description 1 Exposure to perform the testing of Inprocess, Finished product, Stability and Cleaning validation samples etc. 2 Having knowledge of Analytical Instruments to perform the testing by HPLC, GC, UV, IR, KARL FISCHER etc. 3 Having Analytical testing skills to perform the MDI/DPI Products test like Assay, APSD, DDU, RS, Spray Pattern, FPM and physical testing etc. 4 Exposure of Laboratory investigation like OOS, OOT, Incidence, Deviation. 5 Exposure of Stability sample management & Regulatory Audits. 6 Exposure of Analytical method transfer, Analytical method validation / Verification activity. 7 Knowledge of GLP and Good documentation Practices. Competencies Innovation & Creat...

Laxmi Organic Industries Limited We are looking for candidates interested in Technical Associate - Electrical for Dahej. Total Experience 6-8 years with Supervisory License Job Title: Technical Associate Electrical Department: Engineering Reporting to: Sr. Manager Electrical & Instrumentation Functional Area: Electrical Location: Dahej Site IV Job Purpose : Maintaining normal & optimum operation of the plant (field and panel) Role and Responsibilities Strategic : Responsible to prepare the relevant shut down activities & Carrying out the jobs as per requirement. Operational: To check the status of the following day to day. a. Power factor reading. b. Status of all the drives parameters in th...

Long Description Annual maintenance contract preparation and preventive maintenance of QC and IPQA instrument as per approved procedure. Breakdown handling of QC and IPQA instrument as per approved procedure. Upkeep the records of preventive maintenance and breakdown in SAP. Qualification of new instruments and SOP preparation. To participate in failure investigation related to malfunctions. To impart training to the analysts for instruments maintenance and troubleshooting. Co-ordination with vendor service engineer of service /breakdown related activities. To maintain GMP in QC laboratory, Real time documentation. Computer system validation of laboratory instruments. Execution and implement...

Preferred candidate profile Qualification : B Pharma/ M Pharma Experience : Min 3 years in QMS in OSD TrackWise Change control CAPA Deviation Others : Shift : General Female candidates are also eligible. Interested candidate may share resume at hr.plant@zuventus.com

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...

Roles and Responsibilities (Hiring for AQA Role, IPQA Role, QMS Role - API Background is Must) Ensure compliance with GMP, BMR, BPR, SOPs, and quality systems. To Perform Analytical QA Role IPQA Activities QMS Activities Validation Activities Collaborate with cross-functional teams to ensure timely completion tasks Person Should be from the API Background

Roles and Responsibilities Conduct quality control activities such as BMR reviews, stability studies, process validation, and equipment qualification. Ensure compliance with cGMP guidelines and regulatory requirements through IPQA activities. Investigate deviations and CAPAs to maintain product quality and prevent recurrence of issues. Collaborate with cross-functional teams for change control processes and batch manufacturing record (BMR) review. Perform analytical testing using HPLC/GC/UV methods to ensure product purity. Desired Candidate Profile 2-7 years of experience in API manufacturing or bulk drug industry only male candidate. MS/M.Sc(Science) degree in Chemistry or related field; ....

What you will do Let's do this. Let's change the world. In this vital role you will be responsible for leading and charting the course for the Digital Quality Management System (DQMS) product team that builds and transforms technology capabilities that positively impacts business outcomes. Specifically, this individual will be responsible for planning, design, configuration, deployment, and support of Veeva Digital QMS solution. The ideal candidate will have a consistent track record of leadership in technology-driven environments for the Information Systems area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-fu...

What you will do Let's do this. Let's change the world. In this vital role you will be responsible for leading and charting the course for the Digital Quality Management System (DQMS) product team that builds and transforms technology capabilities that positively impacts business outcomes. Specifically, this individual will be responsible for planning, design, configuration, deployment, and support of Veeva Digital QMS solution. The ideal candidate will have a consistent track record of leadership in technology-driven environments for the Information Systems area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-fu...

Job description Should have sound knowledge of QMS System and Change Control, Deviation and CAPA Procedure. Review of Preventive maintenance & calibration of equipment and systems. Investigation and closure of all deviations, OOS and complaints

Establish / maintain compliance with FDA QSRs (GMP) Working with Production teams to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing. Export compliance system, Compliance of labeling, quality control and a quality system for excipients Documentation Control Process and Documentation Change Control Process Good Documentation Good Communication

1) Understand the CTQ for a process 2) Ensure complaince of process parameters and product parameters for the responsible area 3) Educate the operators and ensure adherence of GMP/quality systems in the process 4) indentify non conformances, Deviations- segeregate and quarantine the materials and reporting 5) Basic quality trouble shooting guidelines implementation to assist production to ensure Quality 6) System updation in ERP/ material clearance process completion 7) Deviation process controls 8) customer CTQ CAPA implentation points checking for effectiveness 9) maintaining of the correspoding Lab equipments and testing as per audit plan and reporting and taking actions on NC 10) Reporti...

About Us Tata Consulting Engineers Limited (TCE) is the largest Indian private sector engineering and project consultancy and an emerging global leader in integrated engineering solutions. With more than 60 years of engineering excellence, TCE has a presence in over 64 countries and over 12000 completed projects, the company operates in 3 core Industry segments -Infrastructure (Water, Environment, Urban Development, Buildings, Manufacturing Facilities, Ports and Harbours, Transportation), Power (Thermal, Hydro, Nuclear, Renewable, Transmission and Distribution) and Resources - Hydrocarbons and Chemicals (Oil, Gas and Refineries, Chemicals, Petrochemicals, Fertilizers, Speciality Chemicals, P...