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Key responsibilities
Quality System:
1.Maintenance and implementation of the Quality System via transposition of the applicable requirements (laws, regulations and the elements of the company quality policy, standards and procedures etc.) as are described in the Commercial Quality Manual (CQM).
2.Drive continuous improvement of the Quality System & processes using quality system performance information, in conjunction with information from periodic internal audits, deviation management, CAPA management etc.
3.Drives temporary / short term workforces as are assigned by the Quality Head.
Regulatory Compliance:
4.Ensure that company Innovative Medicine marketed products, packaging components, labelling meet the local regulatory requirements.
5.Support implementation of the regulatory standards management standard and procedures.
Document, data and Change Controls:
6.Prepare, update applicable LOC procedures.
7.Responsible for assigned product change controls and ensure appropriate internal and external change control procedures are followed.
Inspection Management:
8.Preparation, execution and follow up for external inspections for responsible areas.
Escalation of Quality and Regulatory Compliance issues:
9.Notify and engage LOC Head of Commercial Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in Commercial Quality Manual (CQM).
Internal Audit management:
10.Conduct assigned (self-)inspections of GxP practices that are applicable for all regulated functions under COMPANY Innovative Medicine.
Events and Deviation Management:
11.Ensure that all events and deviations for COMPANY Innovative Medicine products and critical systems are suitably, scientifically and logically handled, documented, investigated for route cause and assessed for its impact on product quality and safety.
12.Ensure appropriate corrective actions and preventive Actions (CAPA) are taken to mitigate the effect of an event / deviation as well as to prevent recurrence in the future
Support for Quality Complaint Management
New Product Launch and Product Life-Cycle Management:
13.Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes.
Required Qualification and Core Competencies
1.Bachelor’s degree or higher in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline.
2.>3 years’ experience in the Pharmaceutical or related industry, ideally with a mix of Quality and Compliance (GxP), Distribution Warehouse management, Regulatory Affairs and some Sales & Marketing experiences. Quality and Compliance experience is essential.
3.Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes.
4.Up-to-date knowledge of relevant pharmaceutical legislation and GxP. Full competency in local language and a working knowledge of English.