245 Deviation Jobs - Page 8

"Key responsibilities: Perform analysis, report raw data, ensure data tracing, submit reports, address reviewer comments, follow GLP, report incidents/deviations, review data accuracy, provide training, and handle events as per SOP."

1. Quality Management Systems: Implementing, monitoring, and maintaining Quality Management Systems to ensure compliance with CGMP/regulatory guidelines. 2. Documentation: Reviewing and approving technical and quality documents. Required Candidate profile Should be minimum Post Graduation in Science having the work experience of about 6-7 years of experienced in FMCG company or in pharma industry.

Developing and Implementing QA Systems and Procedures: Responsible for establishing and maintaining quality assurance systems, policies, and procedures. This includes creating SOPs (Standard Operating Procedures), work instructions. Required Candidate profile Strong knowledge of cGMP and relevant regulatory requirements: This includes understanding manufacturing processes, quality control procedures, and validation requirements.

Job Description Labware 7. LIMS implementation, Master data creation, Validation. Caluculation configurations. CSV documentations, Test Script review, Instrument integrations. LIMS trouble shooting and resolutions. QAMS activities, CCP, CAPA, Deviation investigation. Work Experience 4-7 years of experience in QC and LIMS Implementation Education Post Graduation in Analytical Chemistry or Analytical Chemistry Graduation in Pharmacy or Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

Job Description Officer/Executive- Packaging & Development 1. Design, preparation, review and approval of documents - OPMLs, BPRs, Specifications for Packaging materials, In-house Labels and Pallet Matrix. Checking of Artworks and Shade Cards for labels, Primary & Secondary packing materials. 2. Execution and coordination for SAP related activities like loading of master recipes and Bill of Materials (BOMs) for Finished Goods (FGs). 3. Conducting different Trials for Packing Materials, 4. Monitoring and technical support for execution of Packing equipment qualification/ Trial / Scale up / exhibit / commercial process validation batches on packing lines and handling of investigations, if any ...

JOB DESCRIPTION (JD) Designation: Executive/Senior Executive Location: Gurugram Department Name: R&D Quality-CMC QA List of Responsibilities / Job Functions: Review of R&D documents such as stability data, Analytical reports, Method Qualification reports, Method verification reports, Method validation protocols & reports, Working Standard / Impurity Standard profile, analytical data of pilot bio batches and Method transfers protocol & report. Review of Lab event/Deviations/Change control/CAPA and associated investigation reports prior to Technology Transfer. Support and participate in f ailure investigations and resolution of root causes for issues related to systems and products developed w...

Chemveda is hiring for Quality Assurance Executive Position Experience - 2-6 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications ...

Role & responsibilities Key deliverables Supervise compliance of cGMP and any other applicable regulatory requirement, including EH&S requirements. Complete self-training and monitor training of team members on the relevant SOPs. Report any quality concern or suggestion for improvement to managers. Execute and supervise all tasks and activities as per the applicable SOPs. To lead and guide site investigation teams to investigate the reported OOS, repeat OOT, deviations and market complaints by working closely with site CFT and operating personnel, to arrive at appropriate RCA and CAPA. To personally lead major/critical/repeat investigations and ensure proper closures. To review and share wee...

Chemveda is hiring for Quality Assurance Executive Position Experience - 2-6 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications ...

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...