Job Description
JOB DESCRIPTION :
The Quality Support Center (QSC) Supervisor oversee the performance and activities (e.g., training, Computer System Validation, supplier management) within the QSC.
He / She communicates the quality policy and objectives are implemented and maintained in alignment with healthcare guidelines (e.
g., cGMP, GDP, GMP) and ISO 9001 / ISO 13485 requirements. He / She develops standard operating procedures (SOPs), reviews and approves work instructions related to their area of responsibility, trains personnel and internal clients on SOPs and regulatory topics.
This role oversees the activities with the QSC, assesses trends, and communicate recommendations to the senior Quality Leadership.
He / She maintains knowledge of healthcare quality and regulatory requirements and assesses, and addresses risks associated with the regulated activities managed by the QSC.
This position supervises specialists.
Responsibilities and Duties
- Develop and manage Quality records (e.g., validation, supplier management, and training) in alignment with the quality policy and processes for consistent change management practices.
- Manages and executes the Quality System Training Program.
- Manages validation documents, determines applicable regulations, and reviews and approves testing of changes to validated systems.
- Manages the reviews of policies, procedures, regulations, and specific work instructions.
- Develop set of criteria for trending of quality data for their area of responsibility to assist with performance trending.
- Participate in regular internal and external meetings and management reviews for area of responsibility.
- Provide training, support, and developmental opportunities to direct reports.
- Manages resources and people processes (e.g., Performance Management,
Career Development, Training, Staffing, etc.) to ensure the day-to-day administration of processes and formal procedures.
- Provides direction and coordination to his / her team and coordinates regular training(s) related to change controls and risk management.
Preferred Competencies
- Knowledge of the different (Country) regulations and ISO 9001 / ISO 13485 standards is preferred.
- Advanced English
- Strong project management skills.
- Strong analytical and people management skills.
- Good knowledge of a Quality Management System and electronic Management System (eQMS).
- Good knowledge of Microsoft Office (Excel, Word, Outlook, Access).
- Ability to create networks and collaborate with various internal and external stakeholders.
- Ability to prioritize decisions which may have a significant risk for the company.
- Identify potential gaps in the processes and make recommendations for possible improvements.
- Strong time management skill, able to work within time-limits (deadlines).
MINIMUM QUALIFICATIONS
- Bachelor's Degree (or internationally comparable degree) Preferred
- Bachelor's Degree (or internationally comparable degree) Science or related discipline Preferred
- A minimum of 3 years' experience in healthcare industry in a Quality role.
Grade : 20E
Location : Bogotá
Deadline to apply : Monday 17th June, 2024.
Employee Type : Permanent
Permanent
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