Objectives

Support the CCH International entity’s Quality team in the daily operational activities and help the team ensure business unit compliance to procedures and systems, GDP, applicable regulations and guidelines for OTC, food supplements, biocides, medical devices and cosmetics.

Scope : all CCH International export regions/markets

Tasks and Responsibilities

Under the supervision of the Commercial Quality Manager:

Pharmaceutical Operations Management:

• Participate in the daily pharmaceutical operations.

• Handle the daily operational requests from CCHI distributors, partners and support functions (temperature excursions, product related questions, warehousing and transport quality related requests etc.)

• Support with product/batch documentation collection and preparation as required for transport/export activities

  Product Quality and Safety:

• Manage customer complaints from all markets: log the complaints in the system, ensure investigation is made by the appropriate quality team, review investigation outcome and close the complaint

  Escalate major/critical complaints to his/her manager

• Report necessary quality defects to his/her manager.

  Training and Supervision:

• Participate in the training of staff on good pharmaceutical practices: prepare training material, organizing sessions, delivering training etc.

  Documentation and Compliance:

• QMS activities, notably document management : participate in defining and implementing quality policies.

• Participate in internal and external audits and in preparation and follow-up of inspections.

  Change and Deviation Management:

• Participate in changes and deviations management with various levels of investigation to identify risks, root causes, and associated CAPAs.

Required qualifications and work experience

• Degree in Quality, Chemistry, Regulatory or Degree in Pharmacy

• At least 1/2 years’ experience working in a quality function in Healthcare, Pharmaceutical, Cosmetics, Medical Device or regulated products related industry

• Understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks.

• Understanding of regulatory, GMP and GDP requirements relevant to a regulated product

Required core competencies

• Intellectual curiosity and agility

• Solution oriented, self-motivating

• Good interpersonal and communication skills

• Commercial understanding of corporate and operational business issues

• Appetite for learning, exploring new activities and for working with international markets

• Openness to change and ability to think out of the box

• Fluent in French and English

• Prequalification Call with HR

• Interview with the Hiring Manager