06 feb
Cencora | Pharma solutions
Estado de México
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details ON SITE POSITION (Avenida Gustavo Baz 176 Bodega 1 San Jerónimo Tepetlacalco, Estado de México 54090)
Position Summary
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 Clinical Trial, Commercial, and Transport divisions of the organization. They provide guidance to office, depots 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 acting as a first contact for the Country Manager and local team for quality-related topics and ensuring that quality aspects for CCS and Transport are adequately represented during local and global meetings as well as local and global projects and initiatives. Organize and support management review meetings in accordance with applicable SOP.Supplier Qualification Management: Oversee the Suppliers Evaluation Program in accordance with internal guidelines,
including local supplier 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. Ensure suppliers meet quality expectations through audits, performance monitoring, and corrective actions when necessary.Quality Agreements: Review and negotiate quality agreements and Confidentiality Disclosure Agreements (CDAs/NDAs), ensuring alignment with company policies and regulatory requirements.Internal/External Audits, Inspections, and Certification Audits: Be the main auditor contact and communicate with relevant parties within the organization. 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 participate in investigations on non-conformities or deviations from established quality standards. Provide quality input for investigations, root cause analysis, and CAPA; support corrective and preventive action initiatives to address root causes. Assist in creating comprehensive reports, and diligently monitor deviations and subsequent actions as outlined in the specific internal guidelines. Report to global QA and local leadership any deviations or potential problems.Risk Management and Change Control: Assist in setting up and participating in Risk Management and Change Control processes.
Ensure that clients are contacted whenever required to communicate changes such as expansions, depot moving processes, regulatory updates, clarifications, etc.Pest Control and Facility Cleaning: 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 programs according to internal guidelines, supporting the local facility representative and QA manager technical compliance.Documentation Management: Ensure accurate documentation of all quality-related activities such as SOPs, work instructions, test records, audit reports, etc. This also includes organizing regular reviews of Local Standard Operating Procedures (SOPs) and Work Instructions (WIs)
with the process owner/author.Quality Data Management: 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 processes as outlined in the standard operating procedures. Quality Control Quality Checks and Control: Implement 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, identifying defects or areas for improvement.Self Inspection and Quality Checks:
Responsible for quality-related activities related to the Self-Inspection Report and quality checks as defined in standard procedure.Manufacturing (CSS Only)Ensure that the batch processing and final records related to the relabeling operation are reviewed through QA spot checks and documented appropriately.Conduct quality checks and release for GMP-related materials for secondary repacking activities.Conduct and document quality checks for secondary repacking activities. Review the completeness of the batch packaging records and ensure all data are filled in accordance with World Courier's Good Documentation Practices procedure.To review and approve the repacked products to the client for final release and disposition. Ensure that physical batch packaging records are retained and archived. 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) and any other regulatory documentation is/are properly in place and updated as applicable. Quality Training and Education Develop 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).Assign along with local Management and maintain the local training job codes and local training matrix. Monitor training compliance and escalate non-compliance to local management. Process Improvement Identify 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.Participate in client meetings, monitoring client feedback and satisfaction levels to identify areas for improvement in services. Enhance the quality of service delivered to clients by closely collaborating with the operational team. Operational Quality Support (CSS / Responsible Person only) Support recalls and mock recalls in accordance with applicable internal guidelines and client instructions.Act as a witness during the destruction process for stored products, e.g. IMP/Clinical Trial Material or commercial products when required. Commercial Product Handling (Commercial Only) Complete inbound quality checks and confirmation of client's disposition in approval process for 3PL.Review and authorize the change of product status following client instructions and within the scope of applicable Internal Guidelines.Confirm client's disposition of returned, rejected, recalled or falsified products (if applicable).Confirm client's disposition of approving any returns to saleable stock (if applicable). 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.
International support on QA related matters for the local QA network.
People Management (if Applicable) Conduct resource and talent planning: Responsible for overseeing and evaluating employee contributions, performance, and development within the operational quality team. This includes assessing skills, identifying training needs, and ensuring that the team has the necessary resources to perform duties effectively.Monitor work processes and organize work allocation: In charge of monitoring work processes within the team to ensure efficiency and effectiveness. This includes organizing work allocation, assigning tasks to team members based on skills and workload capacity.Implement regular one-to-one meetings: To provide an opportunity to discuss activities, priorities, progress, and any problems the team may be facing. Help foster open communication and ensure that everyone is aligned with goals.Organize or initiate regular team meetings: Responsible for organizing or initiating regular team meetings where knowledge sharing takes place to address common challenges or problems faced by the team collectively. Regulatory Responsibilities
Ensuring along with local management that requirements imposed on certain products by national law are adhered to. Act as a Deputy Responsible Person to World Courier's Wholesale Distribution Authorization. In accordance with local regulatory requirements, the employee is responsible for:
Performing bona fide checks as defined by local regulation and described in local procedure.Deciding on the final disposition of returned, rejected, recalled or falsified products and reporting to the local authority. Educational Requirements
The employee should hold a minimum of a diploma or 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 decisions independently. Supervision and support are required by the line manager for new and more complex situations. 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 and local language.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. OR Able to work independently and lead a team when required. What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Affiliated Companies
Affiliated Companies: World Courier de Mexico S.A. de C.V.
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex
#J-18808-Ljbffr
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.