Senior Quality Systems Specialist
Description:
* Implements and manages the required guidelines and cGMPs, providing LEAN based Quality Systems and Tools, controlled and aligned with the company's strategic plan.
* Promote the importance of high-quality work levels and the importance of a continuous improvement culture in all Quality and/or Regulatory Systems activities.
* Advise Team Members on complex issues which may impact cGMP and ISO standards.
* Lead initiatives with other departments, ensuring plan definition and timely execution
* Review new procedures and policies according to the requirements applicable to the company business and strategy and ensure that the best approach is taken.
* Review and approve Quality and Regulatory Systems & related documentation and training, preparing more complex documentation and tools
* Respond in audits/inspections.
* Master Quality Systems' processes and tools.
* Manage risk and uncertainty, anticipate and escalate roadblocks in order to prevent deviations to the goals
* Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
* Execute professional activities in compliance with Quality, Regulatory and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of the companies policies, systems and procedures.
Qualifications:
* University, or equivalent qualification in Chemistry, Chemical Engineering, Pharmacy or similar scientific field
* Typically requires 5-8 years of relevant overall experience in at least 2 operational and support areas (e.g., Quality Control, Quality Assurance, Manufacturing, R&D, Engineering), preferably within the Pharmaceutical Industry
* Advanced knowledge of Quality and Regulatory requirements
* Understanding of the business with a global insight on the company
* Must have the knowledge, experience and skills to conduct their tasks in accordance with the rules and procedures set down.