Quality Coordinator- Pharmaceutical Distribution

IntePros; Village of New Hyde Park (NY); Vor Ort; USD 70.000 - 110.000; Vollzeit

Zusammenfassung

World Courier seeks a Quality Representative in New York to ensure compliance with local regulatory requirements and company quality standards within the Transport division.

You will guide associates on quality matters, manage QMS, audits, supplier qualification, incident management and CAPA, and drive continuous improvement with regional QA support.

Qualifikationen

• Minimum diploma or bachelor’s degree in a relevant field such as pharmacy, chemistry, or logistics.
• Strong knowledge of quality systems and regulatory expectations.
• Experience leading audits, CAPA and document control activities is preferred.

Aufgaben

• Lead QMS development, maintenance and review; act as primary QA contact for local team.
• Oversee supplier qualification, supplier audits and corrective actions.
• Manage internal/external audits, investigations, CAPA, and reporting.
• Coordinate incident management, non-conformities and quality improvement initiatives.
• Ensure regulatory compliance and file/documentation alignment with SOPs.

Kenntnisse

Quality management

Audits

Regulatory compliance

CAPA

Documentation control

Data analysis

Risk management

Training

Communication

Ausbildung

Bachelor's degree in a relevant field

Tools

MasterControl

SharePoint

Jobbeschreibung

This role, as a quality representative plays a crucial role in ensuring compliance with World Courier policies and procedures at the local level. They are responsible for overseeing quality-related activities within the Transport divisions of the organization. They provide guidance to office and divisional associates on matters of quality and compliance. Additionally, they are responsible for ensuring compliance with local regulatory requirements related to operations and may have regulatory responsibilities in front of local authorities.

Tasks and Key areas of responsibility

• Quality Management System (QMS)
• QMS Management: Developing and maintaining a robust QMS that defines the organization's quality objectives, policies, procedures, and performance metrics. This includes to act as a first contact for the Country Manager and local team for quality related topics. And to ensure that quality aspects for Transport are adequately represented during local and regional meetings as well as local and regional projects and initiatives.

Organize and support management review meetings in accordance to applicable SOP.

• Supplier Qualification Management: Oversee the Suppliers Evaluation Program in accordance with internal guidelines, including local suppliers approval / rejection. This involves working closely with subject matter experts and the local operational team to ensure that subcontractors and suppliers meet the necessary qualifications and standards. To ensure supplier meet quality expectations through supplier audits, performance monitoring, and corrective actions when necessary.
• Internal / External Audits, Inspections and certification audits: To be the main auditor contact and to communicate with relevant parties within the organization. To initiate and oversee the audit organization. Respond promptly to auditor inquiries by providing accurate information, supporting documentation, or clarification as needed. Work with management teams to develop and follow up action plans for addressing any identified non-compliance issues and provide audit responses in due time.
• Incident Management: Review and manage the documentation on incidents. Actively participating in investigations on non-conformities or deviations from established quality standards. Provide quality input for investigations, root cause analysis and CAPA and support corrective and preventive action initiatives to address root causes. Assisting in the creation of comprehensive reports, and diligently monitoring deviations and subsequent actions as outlined in the specific internal guidelines. Reporting to global QA and local leadership any deviations or potential problems.

Ensuring that relevant customer complaints are dealt with effectively.

• Risk Management and Change Control: Assist in setting up and to participate in Risk Management and Change Control processes. To ensure that clients are contacted whenever required in order to communicate changes such as but not limited to expansions, office moving process, regulatory updates clarifications, etc.
• Pest Control and Facility Cleaning: To ensure that pest control and cleaning programs are properly implemented and documented following applicable SOPs.
• Technical Quality Support: Overview and verify technical change controls, calibration, maintenance and qualification / validation program according to internal guidelines, supporting the local facility representative and QA manager technical compliance.

Support the review of temperature graphs as defined in applicable SOP.

• Documentation Management: Ensuring accurate documentation of all quality-related activities such as SOPs, work instructions, test records, audit reports, etc.

This also includes to organize regular reviews of, e.g. Local Standard Operating Procedures (SOPs) and Work Instructions (WIs) with the process owner / author. To support the review of these documents to ensure that they align with established service standards as well as quality and regulatory requirements.

• Quality Data Management: To execute all tasks using dedicated software tools such as Master Control and SharePoint (or other applicable software tools). This includes accurately inputting and timely updating data, attaching relevant documents, tracking progress, documenting actions taken, and adhering to any specific workflows or process as outlined in the standard operating procedures.
• Quality Control
• Quality Checks and Control: Implementing processes to monitor product or service quality throughout the entire lifecycle from design to delivery. This may involve conducting inspections and analyzing data to ensure accuracy and quality of records, to identify defects or areas for improvement.
• Self Inspection and Quality Checks: Responsible for quality related activities related to the Self-Inspection Report as well as quality checks as defined in standard procedure.
• Compliance Assurance
• Ensuring compliance with relevant regulations (local law, GDP, quality regulations etc), industry standards (such as ISO and relevant GxP standards), customer requirements, and internal policies. Staying up-to-date with changes in regulations and triggering / implementing necessary QMS changes.
• Verifying adherence of World Courier employees to all Company Policies and Procedures as applicable to their role and responsibilities through effective monitoring, guidance, and support during standard process implementation.
• Ensure that World Courier License(s) as well as any other regulatory documentation is/are properly in place and updated as applicable.
• Quality Training and Education
• Training Program: Developing training programs to educate employees on quality standards, quality processes, and quality techniques. Ensuring that initial and continuous training programs are implemented and maintained related to Good Documentation, Good Manufacturing, Good Distribution and Good Clinical Practices (when applicable).
• Internal Guidelines Training Management: To assign along with the local Management and maintain the local training job codes and local training matrix. To monitor training compliance and escalatte non-compliance to local management.
• Process Improvement
• Continous Improvement: Identifying opportunities for process improvements through data analysis and continuous evaluation of existing workflows. This may include implementing Lean Six Sigma methodologies or other improvement frameworks in collaboration with the Continuous Improvement department.
• Customer Satisfaction: Participate in client meetings, monitoring client feedback and satisfaction levels to identify areas for improvement in services. To enhance the quality of service delivered to clients by closely collaborating with the operational team.
• Others:
• Keeping appropriate records of any delegated duties and execute tasks and responsibilities as per delegation plan or assigned to the QA support team.
• Any other quality responsibilities assigned by Regional/Global Quality Management.

EDUCATIONAL REQUIREMENTS:

The employee should hold a minimum of a diploma or of a bachelor's degree in a relevant field such as pharmacy, chemistry, biochemistry, pharmaceutical sciences, logistics or engineering. A degree in quality management or a related discipline might also be acceptable.

Key Experience and deliverables expected

• Supervisor, basic experience in quality at least 2 to 5 years

In the role of the quality Supervisor, the employee should have the knowledge and experience to make all routine decision independently. Supervision and support is required by the line manager for new and more complex situtions. Approval of key documents will be done under supervision of the line manager or by the line manager.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

• Good verbal and written interpersonal and communication skills in English.
• Ability to express oneself clearly in conversations, interactions and business writing with others.
• Develop and maintain good relationships with associates at all levels within the company and with external parties (e.g. clients, vendors etc.).
• Good Awareness of Customer Needs.
• Intermediate Awareness of business requirements of the organization.
• Having a high sense of integrity, transparency and accountability in all work tasks and interactions with others.
• Detailed, well-organized and able to multi-task and manage multiple projects at the same time, prioritizing required actions accordingly to meet required deadlines.
• Strong drive to remain focused, self-motivated and committed to completing or achieving tasks.
• Excellent skills in Microsoft Office (Excel, Word and PowerPoint).
• Able to work independently and with a team when required.