quality unit director / qualified person in barbengo / lugano

posted
job type
permanent
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job details

posted
location
barbengo / lugano
job category
Life Sciences
job type
permanent
reference number
13434
phone
058 201 55 50

job description

For our client, a specialist in the manufactuing and development of APIs, we are looking for a:

Quality Unit Director / Qualified Person

Location: Ticino

Contract: permanent

Profile level: senior


Responsibilities:

  • Coordination and supervision of the following department: Quality Assurance, Regulatory Affairs, Quality Controll ( 3 direct report, about 30 indirect report)
  • Optimitation of the Quality System to be more efficient and conform to the normative in collaboration with the Chief and other department
  • Updating of the Quality Systems based on the new regulations and verification by supervision of the processes and quality procedures
  • Act as "Responsabile Tecnico (Qualified Person) for the company for the GMP and GDP defined by the  (OAM) 812.212.1
  • Manage the interaction with the authority, manage the inspections
  • Support the team members in managing the interaction with the clients and personally follow the strategic clients
  • Insure the qualification of the contract manufacturers and suppliers. Evaluate also new suppliers
  • Manage projects in GMP Compliance
  • Contribute to the strategic development of the Quality department of the company

Professionals Knowledge:

  • Good knowledge of GMP applied for the production of pharma product
  • Good knowledge of GDP  (good distribution practice)
  • Good knowledge of rules/ guidelines in pharmaceutical environment (Good Manufacturing Practice as per the ICH guidelines and the USA CFR)
  • Knowledge of Swiss legislation in pharma environment
  • Knowledge of Regulatory Affairs
  • Experience in production process of API
  • Experience in chemistry and microbiology (is a plus)
  • Good knowledge of project management
  • Experience in managing team

Soft Skills:

  • Ability to manage stress and prioritise tasks
  • Good management experience
  • Good communication skills
  • Strong leadership
  • Good critical mind, be proactive and innovative
  • Problem solving and decision making

Education:

  • ?MSc and further education in chemistry, biology or CTF
  • Management education
  • At least 5 years of experience in similar position or 10 years experience as QA, QC or RA in company specialised in API
  • Fluent in Italian and English (verbal and written)