Overview
Quality Auditor 3rd Jobs in Auburn Hills, MI at US Farathane
Job ID R0000034320
Category Quality Management
ABOUT THIS ROLE
Mission
Support the implementation and maintenance of the CHC Affiliate Quality System (covering GxP and health-regulated activities) across the local CHC Commercial organization, to ensure that quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable GxP regulatory requirements.
Support the secure delivery of safe, efficient, quality CHC products, information & services to ensure patients/customers safety and act as Quality Business partner to support business priorities.
Support the CHC CQH and Responsible Person, ensure GDP compliance of wholesale distribution activities within the CHC affiliate marketplace.
Serve as the secondary license holder for Company’s importer and wholesaler licenses
Tasks
GxP and health-regulated activities related to the development, manufacturing, distribution and commercialization of all CHC drug and non-drug products contained in the CHC Affiliate portfolio
Collaboration and support to other CHC Affiliate GxP and health regulated Functions (Regulatory Affairs, Medical, Pharmacovigilance, Clinical, Supply Chain, etc.) and partnership with Business Functions across the CHC Affiliate
Scope of Responsibility
As CHC Affiliate Quality Assurance Associate:
Support the CQH to define, implement, manage and control the CHC Affiliate Quality system across the CHC commercial office, in compliance with CHC Global Quality Policy and standards and with local applicable regulatory requirements.
CHC Affiliate Quality Documentation Management System :
o Organize within the CHC Affiliate a consistent management of Quality Documents related to GxP and health-regulated activities.
o Ensure screening process is implemented on released CHC Global Quality Documents and local regulations to capture the requirements that must be transcribed into CHC Affiliate Quality Documents.
o Provide guidance to CHC Affiliate Functions to develop or update local Quality Documents and related training modules in their respective domains.
CHC Affiliate GxP regulatory inspections:
o Support to manage CHC Affiliate regulatory inspections related to GxP processes owned by the CHC Affiliate Country Quality Head and provide support to and coordination to other GxP Affiliate Functions in country regulatory inspections for processes in their respective areas of responsibilities, ensuring contribution of concerned functions at Global level (as needed).
o Where applicable and required by local regulations and/or expectations of the local Regulatory Authorities, in coordination with CHC Affiliate Regulatory Affairs, support the Health Authorities in their inspections of foreign manufacturing sites.
Support the CQH to act as the contact for GxP quality system audits performed by CHC Global Quality Audits (GQA) within the CHC Affiliate, and support CHC GQA in their audits preparation, conduct and follow-up.
Support the CQH to implement a strategy for local audits based on risk management criteria, of key local GxP and health-regulated subcontractors directly managed by the CHC Affiliate; assure the coordination of the execution of the audits managed at CHC Affiliate level.
Training: Ensure appropriate training to quality basics/quality matters of the CHC Affiliate personnel.
Support the CQH to carry out an annual CHC Affiliate Country Quality Review, including quality oversight on activities executed by CHC Affiliate GxP and health-regulated Functions, and monitor the progress status of the defined Affiliate Quality program actions.
Ensure implementation across the CHC Affiliate a process to manage deviations & CAPAs related to all GxP and health-regulated activities (including those related to audits & inspection observations) and ensure appropriate training of the affiliate personnel in scope.
Support the CHC Affiliate process to manage the changes that may impact GxP or health-regulated process or operations by involving in multidisciplinary exchanges, implementing risk assessment and action plans when necessary.
Monitor and periodically report CHC Affiliate Quality KPIs defined by CHC Global Quality (and any other additional relevant local quality indicators).
Ensure that valid and signed Quality agreements (with the CHC Affiliate as Contract Giver) are in place (with internal CHC manufacturing sites, distribution centers, and/or External Manufacturing hubs, CMOs, distributors), for all GDP/GMP activities under the responsibility of Quality within the CHC Affiliate organization; ensure that quality-related clauses are in place in service agreements for all subcontractors of GxP and health-regulated activities for CHC Affiliate.
Support to ensure an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities, either directly (being involved on selection process, qualification and performance of audits) or through coordination with the concerned CHC Affiliate Functions, as appropriate.
Ensure that quality risks are properly managed across the CHC Affiliate
Escalate and manage the quality events occurring within the CHC Affiliate according to defined processes and standards.
Ensure the availability of up-to-date administrative records (e.g. CV, Job Description, Training log) for CHC Affiliate Quality positions as well as CHC Affiliate up-to-date organization charts; provide guidance to CHC Affiliate GxP and health-regulated Functions to be compliant with this requirement.
Maintain an up-to-date local inventory of GxP computerized systems and GxP spreadsheets in use within the CHC Affiliate for GxP and health-regulated activities, and guarantee they are validated by the relevant ITS functions in charge.
Manage CHC products quality complaints received by the CHC Affiliate and perform trend analysis.
Support CQH to lead and coordinate CHC product batch recalls and ensure prompt execution of recall operations in coordination with other Functions within the CHC Affiliate, as per CHC Global Quality recall process.
Ensure quality oversight on management of CHC product distribution issues including temperature excursions.
Where applicable (as per local regulatory requirements):
o Perform local Market Batch Release/Disposition
o Ensure quality oversight on local distributors (“Buy & sell CHC products” partners)
o Support to manage notifications from and to local Health Authorities for CHC product related quality events in liaison with other CHC Affiliate Functions as appropriate
As CHC Affiliate Quality Business Partner, foster quality culture across the CHC Affiliate, interact closely with CHC Affiliate stakeholders to provide appropriate quality input and agile support to local CHC business and CHC e-commerce business.
Support CQH to manage CHC Affiliate Quality budget.
Be the backup for other countries’ CQHs (as applicable) during his/ her absence as mutually agreed (as applicable) to perform critical Quality tasks or manage quality related notifications or alerts.
Support for other assigned tasks and projects by line manager as applicable.
As CHC Affiliate GDP/Wholesale Distribution Secondary License Holder:
Ensure that all the Importing and Wholesale distribution activities covered by the corresponding Importer and Wholesale Distribution License are operated by the CHC Affiliate in full compliance with GDP requirements.
The responsibilities of the Importer and Wholesale Distribution secondary license holder are the following:
Ensure obtaining the GDP/WDL license and maintain it up to date
Ensure that a Quality Management System has been implemented and is maintained
Focus on the management of authorized activities and the accuracy and quality of records
Ensure that initial and continuous training programs are implemented and maintained
Coordinate and promptly perform any recall operations for CHC products
Ensure that relevant customer complaints occurring in the distribution channels are dealt with effectively
Decide on the final disposition of returned, rejected, recalled or falsified CHC products
Approve any returns to saleable stock
Ensure that processes are in place in order to handle out of stock situations and associated communication to relevant parties, in coordination with other CHC Affiliate Functions (e.g. Regulatory Affairs, Supply Chain, Medical)
Ensure that suppliers and customers are approved
Ensure that CHC products are being distributed only to validated customers
Approve any subcontracted activities which may impact on GDP
Keep appropriate records of any delegated duties
Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
Ensure that any additional requirements imposed on certain CHC products by Singapore territory law are adhered.
Where required, be the primary license holder during interim period of CQH transition (as applicable).
Support for Regulatory Administrative in Health Authority’s system
Support regulatory administration submission for applications through health authority system or local government applications.
Management Responsibilities :
The role holder has a direct reporting to ASEA Zone Quality Head (also CQH of Opella Singapore).
Latitude of Action :
The role holder is required to work in line with CHC Global Quality Policy, Standards and Processes.
Role Impact :
lt is a key role in ensuring consistent application of Quality requirements across the CHC Affiliate.
Scope :
It works together with CHC Affiliate GxP functions such as Medical Affairs, Regulatory Affairs, Pharmacovigilance and Supply Chain as well as with colleagues from other Quality operational units as required.
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Title: Quality Auditor 3rd
Company: US Farathane
Location: Auburn Hills, MI
