Commercial Quality Manager DACH Nordics

Closed - Heidelberg - 10-05-2019 zur Vakanz  

Safety, Quality & Compliance
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Fri 10 May 11:40
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Thanks for your interest in the Commercial Quality Manager DACH Nordics position. Unfortunately this position has been closed but you can search our 0 open jobs by

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A fantastic opportunity for a Commercial Quality Manager to join RB's Hygiene Home Business Unit.

Key parts of this role will include:

Local Quality Management System (QMS)
  • Responsible to support the GM’s and their management teams to enable them to develop and implement the Quality Management System (QMS) to ensure fully compliant products
  • Provide leadership on continuous improvement projects, quality initiatives, etc. as established by corporate Quality Management
  • Work with local functions to develop and maintain all relevant procedures in line with the requirements of the Global BMS & associated policies, relevant codes of practice and GDP
  • Ensure that the QMS is maintained in a state of inspection readiness
  • Ensure a system is in place to manage local embellishment, re-pack, and co-packing work to meet all regulatory requirements
  • Change Management - Develop and maintain a robust and effective change control system to ensure business changes are effectively managed
  • Training – Develop and carry out training for each business relevant to the RB global QMS & to the local QMS, and in cooperation with local Regulatory any significant changes in the legislation which impact the business
  • Issue Management - Investigate quality issues (Non-conformances) and failures (Critical Events) and apply Corrective and Preventive Actions (CAPA) to prevent recurrence. Advise regarding CAPA necessary at regional quality level for items not under local control. Ensure that improvements to products and procedures can be identified and fixed
  • Audit /Inspection Management – Ensure that processes are in place to assess the adequacy and effectiveness of the local QMS. Audit should cover all aspects of the global and local QMS to ensure compliance. Ensure a routine review programme and audits are in place for Third Party providers
  • Document Management – Maintain a document control system for the local QMS. Perform reviews and approve business Standard Operating Procedures (SOP) & Technical Agreements
  • Product Recall - as per the Critical Quality Events and Product Recall SOP establish and communicate responsibilities. Conduct mock recall exercises to confirm adequacy of the local recall procedure
  • Maintain a Fit-For-Purpose QMS: Report level of compliance of local QMS versus global QMS, Policies and GDP regularly to GM’s, Regional SVP’s, Supply SVP’s, (via Management Review, metrics and KPIs) and drive closure of gaps to maintain compliance.

The individual should understand:
  • The Role of REACh compliance
  • Requirements to maintain compliance for HH products in the cluster
Freight, Distribution and Embellishment
  • Responsible for the quality oversight of freight-in operations, distribution and embellishment activities
  • Responsible for initial compliance assessment and approval of Distributors & Embellishers handling products
  • Prepare Technical Agreements (TAs) for Distributors & Embellishers – ensure all quality expectations are included (e.g. change management, product handling, product release, responsibilities)
  • Responsible for continuous compliance & quality follow-up of approved Distributors & Embellishers
Interface with Regional /Supply Quality
  • Work with regional and Supply Quality teams to ensure implementation of appropriate controls to ensure consistent quality of products
Co-ordinate inspections
  • Co-ordinate and host external inspections by External Authorities, third-parties and Reckitt Benckiser in cooperation with Regulatory
  • Co-ordinate follow ups and responses after external inspections. Ensure that any CAPA is resolved in a timely manner

Is this you?

Degree in natural sciences. A PhD or a Master Degree in Quality, Chemistry, Regulatory or Degree in Pharmacy would be nice to have
  • Around 5 years’
experience working in a quality compliance function in Hygiene, Healthcare, Pharmaceutical, or Medical Device related industry
  • Experience in developing and maintaining a robust QMS
Auditing skills, appropriate qualifications in auditing an advantage
Clear understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks
Good understanding of regulatory, GMP and GDP requirements relevant to a regulated product
Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP
Fluent in English
Fluent in German

In return, RB offers very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.

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zur Vakanz

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