245 Deviation Jobs - Page 10

We are looking for a meticulous and analytical individual to join the Revenue Assurance team as an Supply Executive Quality Check (Mystery Audit Process). The role is crucial in validating the integrity and accuracy of mystery audit reports conducted across OYO hotels. You will act as the first line of defense in ensuring audit quality, SOP compliance, and actionable insights to minimize revenue leakage. Key Responsibilities Audit Quality Review: Review mystery audit observation letters submitted by field auditors. Validate correctness and objectivity of deviation findings (e.g., mismatch between physical room occupancy vs OYO Tab data). Ensure reports are detailed, evidence-backed, and erro...

Role Summary: OSD Production QMS is responsible for ensuring adherence to quality standards within the production process. The role involves monitoring production activities, implementing quality control measures, maintaining compliance with regulatory requirements, and driving continuous improvement initiatives. Roles And Responsibilities Quality Compliance: Implement and monitor compliance with QMS standards Industry-specific standards. Conduct periodic audits of production processes to identify deviations and enforce corrective actions. Ensure all production processes align with regulatory and company quality standards. Documentation & Reporting: Maintain and update standard operating pro...

Role & responsibilities To carry out investigations related to OOS, OOT, Incident and Extraneous Peaks to ensure their closure and implementation of CAPA. Responsible for execution of Regulatory Notification as per SOP. To ensure implementation of all proposed actions identified as a CAPA of investigations related to OOS, OOT, and incident. Review of investigation reports, hypothesis protocol and hypothesis reports related to OOS/OOT and Incidents. Co-ordination with R&D, Production, Central Cell, CQA and other responsible for investigations. To prepare and review Quality documents such as (but not limited to) protocols, reports, SOPs STPs Specification, Investigation. Preferred candidate pr...

Job summary We are seeking an individual to perform the Preventive Maintenance and Break Down Maintenance of Analytical Equipment's present in Quality Control . Roles & Responsibilities To perform the preventive and breakdown maintenance of analytical equipment's or Instruments like HPLC, UPLC, GC-HSS, Dissolution Test Appratus, Titrators, FTIR, UV-VIS Spectrophotometer,.... To update the preventive maintenance plan whenever addition of instruments or match the calibration schedule. To prepare the task lists for all analytical equipment's and update them in SAP. To perform the preventive maintenance as per the PM schedule. To make sure of closing the generated PM orders in SAP after performi...

Conduct preliminary review of: Batch Documentation Certificates of Analysis (CoAs) Change controls, deviations, and investigations Support preparation, review, and maintenance of: Specifications Test methods Master Manufacturing and Packaging Records Product artworks and labeling components Coordinate with contract manufacturing organizations (CMOs) for resolution of documentation queries and ensure timely turnaround. Assist in documentation for supplier qualification and product transfers. Maintain and update product master data in SAP, including: Material codes Specifications and test parameters Change control linkages Artwork version control Track and report progress on key quality action...

Job Description Preparation & Review of SOP’s of QA system and review / approval of SOP’s of other departments. Review of master BMR/BPR of commercial and exhibit batches. Review of BMR / BPR, scale-up and placebo batches. Review of executed BMR/BPR of commercial and exhibit batches for batch release. Issuance, Retrieval & Destruction of SOP’s, STP, specification, BMR/BPR, annexures & other formats. Login and review of quality system documents such as Deviation and IPOOS. In-process Quality Assurance during Production / Packing activities. Sampling at different stages of manufacturing / packing as per the requirement (In-process, BU, CU, finished, control, QP, Hold Time & stability etc.) Rev...

Role & responsibilities To plan, schedule and conduct technical training program for new recruits / existing employees by self / internal or external faculty. To work with HODs of respective units to perform training need analysis and make the training plan accordingly. To prepare training SOP (s), yearly training plan and schedule and GMP / technical training modules. To review and conduct the basic GMP training for contract workers. To work with the department training coordinators and HODs of respective units to support in designing and development of training modules / presentation, assessments and documentation and to ensure that the employees are receive suitable training, assessment, ...

Role & responsibilities To carry out Investigation of Incident, OOS (Out of specification), OOT (Out of trend) and Market complaint with the help of concerned departments. Review /generate control number of Incident/CAPA /OOS/OOT & Market complaint. To prepare and review of Quarterly and Annual trend of incident, OOS, OOT, Market complaint and CAPA. To review raw data and supporting documents for Incident, OOS, OOT, Market complaint and CAPA. Responsible for follow up and implementation of CAPA (Corrective and preventive action). Communication with production, Quality control, Warehouse, Engineering, HR and SHE for closing of OOS, OOT, Incident, Market complaint and CAPA. To prepare supporti...

Role & responsibilities RESPONSIBILITIES: - To follow the cGMP Rules and regulation. Documentation Control: maintenance, updation and issuance of documents in compliance with regulatory requirements and implementation of Good Documentation Practices. Review and approval of all Master documents like SOP, Batch Manufacturing record, Batch packing record, Calibration schedule, Preventive maintenance Schedule and other quality related documents Responsible for preparation and review of protocol and report for Process validation, Cleaning validation as per the schedule and validation master plan. Handling of documents like SOPs, formats / Annexures, Log Books, BMR / BPR & all other GMP Documents ...

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

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 10 Yrs in Chemical .

Role & responsibilities 1. To maintain the technical details of all manufacturing sites. 2. Review of received URS from site for new procurment/Equipment. 3. Global review of URS requirement,technology and software for harmonization 4. Review of proposal as & when required. 5. Co-ordination with plant & HO. 6. Knowledge of quality assurance & documentation.

Greetings from Zydus, We are looking for a Production QMS Head for our SEZ 1, Matoda plant . Key Responsibilities would be: Responsible for monitoring of all manufacturing related activity performed in GEN & ONCO OSD facilities subjected to QMS . To ensure effective implementation of organization vision, mission and goals at site to achieve the expectation. To provide leadership and direction to the QMS team. To participate in monthly Technical Review Meeting, ensure implementation of actions derived against this review and provide recommendations for continuous improvement. To support planning, scheduling and achieving production targets with optimum utilization of resources. Responsible fo...

Role & responsibilities Review of the executed manufacturing documentation at contractual partners and ensure its compliance with internal Quality Management System and applicable Regulatory Guidelines in cooperation with Quality Management at Krka. Reviewing the manufacturing documentation of pharmaceutical products and identifying potential errors or irregularities. Participates in investigation of deviations, complaints, unfavorable trends, and OOS results with contractual manufacturers. Participate in harmonization of applicable change controls. Takes part in organizing audits of our contractual partners in line with the audit plan and monitors its realization. Monitors the manufacturing...

EXPERIENCE IN API WITH QMS SECTION. INCLUDING CHANGE CONTROL, DEVIATION, OOS, PROCESS VALIDATION, CLEANING VALIDATION. ETC

Experience in QMS Section. Change Control, Deviations, CAPA, OOS, OOT, Batch Release Audit

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...

Job Description 1 Knowledge of operation & maintenance of Utility equipments like Chiller, Air Compressor, DG set, Boiler, Water pretreatment plant, UPS & ETP. 2 Should have adequate knowledge of Electrical maintenance of HT & LT Electrical Panels, Breaker and Transformer. 3 Hands on experience of qualification/validation of equipments, SOP preparation, PM, calibration of equipments, 21-CFR compliances. Should have knowledge of regulatory guidelines related to Engineering i.e. Water system, HVAC & compressed air. 4 Work Experience in USFDA / MHRA approved plants is must. 5 SAP Knowledge, Auto cad, Exposure to online documentation like SAP PM, eLog Books, QAMS. Work Experience 8-15 Years Educ...

- Document issuance tracking - Issuance of documents - Checking of stamped documents - Record keeping of issued documents - Review of documents - Coordination with QA team and all others at site - Management of excel files and dashboard Job Location: Kadi, Gujarat ( Bus transportation facility available) Note: Immediate joiner will be preferred first

Responsibilities: Initiation/Review of change control, impact assessment and management of change control records. Preparation of Annual Product Quality Review & MRM record. Review of Vendor questionnaire and related documents. Handling of deviation, market complaints, out of specification and CAPA. Review of Investigation of Deviation, OOS & Other Non-Conformities. Review Of Validation, Qualification CSV Document. interested candidates can share resume to hr3@sarthee.com or call at 9033033650