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Qualified Person & Quality Assurance / Control Manager

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Date: 14-Jul-2018

Location: Therwil, BL, CH

Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognised brand names as Colgate, Palmolive, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom’s of Maine, Sanex, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Science Diet, Hill’s Prescription Diet and Hill’s Ideal Balance.

For more information about Colgate’s global business, visit the Company’s web site at http://www.colgatepalmolive.com. To learn more about Colgate Bright Smiles, Bright Futures® oral health education programme, please visit http://www.colgatebsbf.com. To learn more about Hill's and the Hill’s Food, Shelter & Love programme please visit hillspet.com. To learn more about Tom’s of Maine  please visit  http://www.tomsofmaine.com.

Location: Therwil, Switzerland, Switzerland
No Relocation Assistance Offered
# 66085

 

Scope of Responsibilities

Fachtechnisch verantwortliche Person (fvP) for Colgate-Palmolive Europe Sàrl and GABA Schweiz AG – 40% FTE

  • Error-free, competent and efficient supervision of the Pharmaceutical Quality System of Colgate-Palmolive Europe Sàrl (European Division) and GABA Schweiz AG (Swiss Affiliate) in accordance with the legal requirements of the Swiss Therapeutic Products Act and Ordinance on Establishment Licenses, and European Regulations and Guidelines.
  • Direct technical supervision of operations and, in particular, ensures the proper and safe handling of Investigational/Finished Medicinal Products and Medical Devices.
  • He/she is responsible for ensuring that the manufacturing and distribution of Medicinal Products complies with the current Good Manufacturing and Distribution Practices (GMP/GDP).
  • Approval of Returns to saleable inventory, approval of Suppliers and Customers, and Market Release of Medicinal Products for import into Switzerland.
  • Conducting Audits (Swissmedic Inspections, Internal Audits/Self-Inspections, Suppliers, Contract Manufacturers and Third-Party Logistics Providers Audits)

 

Quality Assurance and Quality Control Manager of GABA Therwil GmbH plant – 60% FTE

  • Ensure that all relevant documents (i.e. Standard Operating Procedures (SOP), Work Instructions (WID) and Forms) regarding Active Pharmaceutical and Cosmetic Ingredients are available and reflect the actual processes.
  • Technical Release of Raw Materials, Packaging Material, Intermediates and Cosmetic and Pharmaceutical Active Ingredients.
  • Maintenance and further development of the Quality Management System (QMS) of GABA Therwil GmbH in line with Colgate-Palmolive Quality Standards, cGMP and Swiss Regulations.
  • Maintain Customer Complaints reporting for all products manufactured at GABA Therwil.
  • Report of Non-Conformances and Deviations.
  • Definition, implementation and follow-up of Corrective and Preventive Actions.
  • Management of Change Requests.
  • Ensure that an effective system is used for maintaining and calibrating critical equipment: Annual Calibration and Maintenance Plan of the QC Laboratory.
  • Liaison with Facility & Operations Management for the annual Calibration and Maintenance Plan of the Plant;
  • Reporting of Key Performance Indicators.
  • Preparation of Annual Product Quality Reviews.
  • Contribution to Internal and External Audits program.
  • Implementation of Colgate-Palmolive Quality Standards on site.
  • Approval of Specifications, Sampling Instructions, Test Methods, Master Production Instructions and other Quality Control procedures.
  • Quality documentation of Experimental Manufacturing Orders (EMO).
  • Contribution to regular Site Quality Review meetings and Quality reporting.
  • Training of Personnel.
  • Contribution to Internal and External Audits program (under Colgate-Palmolive ESM Program, when applicable).

 

Key Competencies

  • As per Swissmedic Technical Interpretation I-SMI.TI.17:
    • Higher studies (university or equivalent / higher technical institute) in the area of Natural Sciences, Pharmaceutical Sciences, Medicine or Engineering
    • Planning/Priority setting
    • 2 - 3 years at Pharma GMP environment, preferably in Quality Department (QA and QC), Research & Development, Manufacturing.
    • Approved fvP (preferential) or Deputy fvP

 

  • Communicates effectively with different stakeholders, Team Player
  • Effective execution, takes initiatives
  • Planning/Priority setting
  • Problem solving
  • Lead audits
  • Build right network and work environment
  • Establish quality awareness within the organization (across Europe and Switzerland)
  • Coaching and promotion of teamwork
  • Analytical and decision making

 

Additional Requirements

Travel Required [%]

< 15-30%

 

Languages

  • English, fluent written and spoken
  • German, fluent written and spoken
  • Additional Languages are a plus.

 

IT Skills

  • Windows OS [Word, Excel, PowerPoint, Visio]
  • Google Apps
  • SAP R3
  • Wave is a plus

Are you interested in working for Colgate-Palmolive? You can apply to work with us using this online application. Attach all relevant documents such as a cover letter and resume or CV. Applications received by email are not considered in the selection process.

Become part of our team. We look forward to your application.

Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, or any other characteristic protected by law.


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