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.
