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Quality Unit Director / Qualified Person

Barbengo, Switzerland | Randstad

  • Industry:
    HR / Recruitment Services
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Quality Assurance
  • Experience:
    5-7 years
Job Description:
110 people have viewed this job

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)


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