Healthcare QA Sup-Qualified Person and Responsible Person

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Job Description:

Job Summary
The Healthcare Quality Assurance (QA) Supervisor-Pozzuolo Martesana BOMI Site communicates the quality policy and objectives to help ensure the maintenance of the overall healthcare compliance for the operation/department. The successful candidate will advise on development of standard operating procedures (SOPs), reviews and approves client and facility work instructions, trains QA personnel and internal clients on SOPs and regulatory topics, and oversees the maintenance of the quality documents. This position participates in internal, client, and agency audits, and follows up on audit outcomes. The HC Quality Assurance Supervisor maintains knowledge of healthcare quality and regulatory requirements and assesses and addresses risks associated with transporting healthcare and food products. Manage GMP Quarantine Site as Qualified Person, manage as GDP responsible person what around distribution.
Responsibilities:
Monitors and instructs for compliance to UPS HC site license requirements.

Promotes Issue resolution, risk management, continuous improvements and project initiatives.
Facilitates, hosts, and respond to audits (Internal, Regulatory Agencies and Clients)
Assists with creation, revision, and approval of Controlled Documents (SOP/WI/Forms).
Provides investigation and Non-conformance reporting, including development of proactive strategies for preventing recurrence.
Changes control management.
Provides Quality and Regulatory compliance guidance to clients and internal staff.
Supports growth of new and expanded facilities, clients and services.
Participates in environmental control and CDS security emergency response action team.
Performs direct reports responsibilities (risk assessment, task delegation, performance evaluation, skills development, constructive feedback, formal performance review, formal career development)

Qualifications:
Bachelor's degree Pharmacy, CTF Required
Quality Assurance experience - Preferred
QP elegible mandatory

Location: Pozzuolo Martesana

Employee Type:
 

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