Quality Operations Specialist
Sandoz Grup
Kocaeli, Turkey
son 4 saat

Job Description

To ensure that GMP requirements defined by MOH, Novartis / Novartis / Sandoz Quality Manual are completely and effectively implemented.

To comply with Novartis Data Integrity policiy & rules. To comply with Novartis Privacy declaration & procedures. To inform related department in case security events&violation.

Establish Quality Culture and awareness. Keep the confidentiality and originality of all documents. Comply with local regulations related to HSE and Novartis / Sandoz policies Contribute to saving projects in order to reduce costs, improve new projects and help to complete Quality Assurance related projects.

Ensure and implement all aspects of Quality, Occupational Health, Wellbeing, Safety, Environment, Emergency Management and Business Continuity according to Novartis Policies / Guide Lines / Operational Procedures and Legal Regulations for responsible area / unit / operations, and contractor operations.

Handling of Transport Deviations. Validation and Qualification Operations,Audits. Revision of existing SOPs and / or generation of new ones based on the related QM / QD / GOP.

Support for preparation of Technical Reports (Cockpit,..etc) reported by Quality Unit. Providing active, real time periodically GMP checks and Ensures quality oversight at Engineering, External Service Provider(REFS), IT and Warehouse&SCM.

  • To Deputate QA in Quality Control. Evaluating and approving facilities, utilities and equipment qualifications. Review of the all SOPs related with engineering;
  • REFS, IT&SCM. Control and approve of the annual calibration and qualification plan. Supporting the new equipment commissioning.

    Review of the BMS trends. Monitors service provider performance on local level. Evaluate and review CSV operations. Review of cleaning validation protocols o give refreshing GMP trainings whenever required.

    To support the implementation of GMP training program. Supporting the evaluation and completion of change control actions.

    Tracking of CAPAs. Handling the transport validation system.

    Minimum requirements

    University Graduate Chemistry, Chemical Engineering, Biology or Pharmaceutical Education Fluent English Min. 3 years experience in pharmaceutical sector.

    Possession of the necessary GMP understanding, observation capacity, training and experience in order to realize Quality Assurance activities in a correct and effective manner

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