Cmo Quality Manager Medical Device

7 giorni fa

Milano, Lombardia, Italia Cooper Consumer Health A tempo pieno
Requisition ID

  • 13 Job Family 1 Other


 Country 1
  • Italy


 Location 1
  • Hybrid
  • About us
-
Cooper Consumer Health is a leading European consumer healthcare player that develops, produces, and distributes a diverse range of OTC (over-the-counter) products with strong brands such as Valdispert, Oenobiol, Excilor, Vitascorbol, Lashyle and many more.


With a presence in seven countries, we supply more than 80,000 independent pharmacists, e-commerce players, wholesalers, drugstores, and hospitals, generating around €600m in revenue.

Headquartered in Paris and with almost 1,000 employees, we take an entrepreneurial approach with strong local accountability. Our 'global-local' culture and bias towards action allow us to operate with agility and speed.


At
Cooper Consumer Health, we are driven by our mission to help people improve their own health and wellbeing using effective selfcare solutions.

We rely on our talented employees to achieve this, empowering them to take ownership of their work, think outside the box and challenge the status quo to drive innovation.

We value a culture of respect, transparency, and inclusivity, where everyone is treated with dignity and fairness.

  • Job description 1
-
JOB DESCRIPTION


You will be responsible for leading Quality Management system implementation with CMO for the group and ensuring CMOs compliance to global CCH requirements and that the products meet regulatory requirements.

Your area of focus will be Medical Devices. You will manage CMO audits or visits and also the qualification process of new CMO.

You will also communicate with CMOs in regards to quality requirements and work closely with Procurement, R&D and Quality in order to solve any issues.


RESPONSABILITIES

  • Report complaints to CMO for quality investigation and challenge root cause and follow up on CAPA
  • Ensure CMO activities are fully compliant with regulatory and CCH guidelines to minimise risk to consumers, company and brand name.
  • Recommends suspension of supply on the basis of failures in Supplier quality management systems.
  • Quarantine of stock where there is doubt on assurance of quality, safety and efficacy of finished products to be sold.
  • Manage CMOs in all quality related tasks and build up and maintain close relationship with CMOs.
  • Responsible for overall Quality management system for CMOs
  • Responsible for selfinspection program and audit readiness for corporate/external audit for the CMO under remit
  • Performing CMO Quality management review and CMO quality KPIs, main quality issue and improvement project/opportunities
  • Lead all investigations regrading defected products with the impacted CMO
  • Insurance of CMO team compliance to corporate global, local SOPs and Electronic Quality systems
  • The approval (or rejection) of new CMO/ suppliers
  • Development and maintenance of the ongoing supplier assessment and reapproval programme based on risk.
  • Ensure 3rd party activities are fully compliant with regulatory and CCH guidelines to minimise risk to consumers, company and brand name
  • Review/ approve and report on monthly basis the change control and nonconformity process for CMOs
  • Ensure Quality Technical agreements are in place and approved.
  • Work closely with Marketing, regulatory, Procurement, Supply and and other QA personnel in markets to resolve quality issues with suppliers and contractors that may affect consumer safety, regulatory compliance, customer satisfaction and operational performance.
  • Conduct Quality Review, document the process and report to global quality team
  • Approve APR for pharma product
  • Audit and control of 3rd parties quality performance to CCH, including but not limited to finished product contractors, active ingredient suppliers, raw material and component suppliers.
  • CAPA follow up
  • Monitoring the quality performance of existing suppliers/contractors and their ongoing approval as a supplier to CCH.
  • Ensure CMOs updated Site master files (SMF) and Site Validation master plan
  • Lead Mock Recall/recall processes for products produced at CMO
  • Collation of information supporting continued approval of 3rd parties and products and ensuring CCH continued confidence in the 3rd party to perform at the required standard to supply CCH.
  • Regulatory compliance of CCH maintained with regard to suppliers and contractors.
  • Resolution of quality issues that may affect consumer safety, regulatory compliance, customer satisfaction and operational performance.

COMPETENCIES

  • 10 years of experience in quality manufacturing and CMO management
  • Strong QMS knowledge and product manufacturing knowledge
  • Thorough knowledge of the regulatory and quality requirements and guidance covering the manufacture of medical devices.
  • Experience in good manufacturing practices (GMP)
  • Experienced auditor, ideally with Lead Auditor or similar qualification.

Other information

  • Flexible work / home office (3 days in the office and 2 from home)
  • F

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