335 Deviation Jobs - Page 14

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