Hc Quality Assurance Associate Manager(Audit)

UPS Türkiye

We are looking for a Healthcare Quality Assurance Associate Manager (System Audit) to work at UPS Healthcare.

SUMMARY

Perform and reviews assessments of computer systems using predetermined healthcare industry standards ensuring compliance with governmental regulations and UPS quality policies.

JOB PURPOSE AND KEY RESPONSIBILITIES

·       Stays current with computer systems industry compliance and validation standards.

·       Manage internal audit schedule and necessary updates

·       Execute Internal audits to audit plan

·       Assess and approve site response and audit improvement plan

-          Ensure site audit improvement plan includes root cause analysis of findings

-          Ensure appropriate and timely action plans and effectiveness verification checks are documented in the audit improvement plan

-          Ensure response complete and accurate

·       Track and report to senior HC compliance management site audit improvement plan progress to approval

·       Notify as appropriate if audit improvement plan is not progressing

Management of Quality Documents and Procedures

·       Review and approves departmental standard operating procedures and work instructions.

·       Ensures proper procedures are followed by Information Technology (IT), Plant Engineering (PE), and any other personnel involved in the use or maintenance of healthcare computer systems.

·       Evaluates procedures across computer systems to identify overlaps and gaps in procedures and guidelines and ensure consistency in content and implementation.

·       Interfaces with Corporate Compliance as needed for changes in industry guidelines.

·       Assists in coordinating validation documents and data control (e.g., numbering, version control, controlled copies, etc.) to ensure an orderly manner is maintained and quality standards are met.

·       Controls the implementation of training programs and materials to ensure effective training for QA personnel and internal clients.

Client Audits and Regulatory Agency Inspections

·       Conducts pre -audits to ensure agenda information is in compliance with the requirements and specifications.

·       Ensures the required information is gathered to prepare for internal, external and client audits. Coordinate and participates in regulatory agency inspections, internal Corporate Compliance audits and client audits.

·       Works with business departments and upper management to determine appropriate corrective and preventative action plans.

·       Responds to audit observations with appropriate corrective and preventative action plans.

·       Track and trends audit findings.

·       Maintains proof of audits and documentation.

·       Conducts follow -up activities to ensure closure of audit findings.

Internal, Client and Regulatory Agency Support and Communications

·       Consults with internal groups (e.g., Operations, Business Development, IT, PE, etc.) to investigate and resolve healthcare issues regarding compliance and regulations

·       Monitors agency and client follow -up after inspections and discovery of internal issues to meet respective agency requirements in a timely manner.

·       Assists with regulatory agency correspondence to interpret rules and regulations.

·       Determine licensure requirements and submit required documentation.

·       Interfaces with client QA departments.

·       Attends business reviews to support the coordination of client activities.

·       Reviews policies, procedures and regulations with clients to determine specialized requirements and ensure compliance.

KNOWLEDGE AND EXPERIENCE

·       Bachelor’s Degree required

·       Previous Quality Assurance/Regulatory Affairs experience in a cGMP/ISO/healthcare/Pharmaceutical environment .

·       GAMP standards

·       Certification in auditing (ASQ CQA or equivalent)

·       Strong understanding and experience working with the various components of Quality Management Systems & cGMP requirements .

·       Proficiency in English required

·       Minimum 5 years of working experience in related position

·       Experience in managing staff

·       Superior leadership, influence and negotiation skills

·       Great personal communication skills

·       Strong verbal and written communication skills

·       Ability to manage up and down the organization

·       Strong organization, time management and planning

·       Strong attention to detail

·       Critical thinking and problem solving skills

·       Proficient in Microsoft Office (e.g.Excel, Word, PowerPoint and Access)