Qualified Person

**Job Title**: Qualified Person (GDP/GMP)

**Job Location**: Switzerland

**Job Overview**:
According to Art. 10 of the Swiss ordinance on establishment licenses the qualified person ensures that the medicinal products are distributed in accordance with the rules of good distribution practice (GDP) and Swiss legislation and that these products are handled appropriately.

According to Art. 5 of the Swiss ordinance on establishment licenses the qualified person ensures that the medicinal products are handled in accordance with the rules of good manufacturing practice (GMP), Swiss legislation, and current specifications and is responsible for the quality of the drug products, which are packed, labeled and/or randomized at Caidya AG.

The Qualified person is authorized to issue instructions within this field of activities also towards management.

**Job Duties and Responsibilities**:

- Review/Release of local SOPs related to the handling of medicinal products (incl. import, wholesale, manufacturing/re-packaging, export)
- Training of local staff regarding quality management and manufacturing and handling of medicinal products incl. applicable guidelines and regulations, documentation and tracking of training
- Preparation, host, and follow-up of GDP/GMP inspections by Swiss MOH.
- Planning, performing, and documenting internal audits in GDP/GMP environment
- Ensure that import, export, and wholesale of the medicinal products is conducted in accordance with applicable guidelines and regulations
- Decide on release / non-release of each batch intended for the Swiss market (product with marketing authorization only), independent from management
- Ensure that each batch of medicinal product imported into Switzerland is compliant with the Swiss marketing authorization dossier and manufactured in compliance with current GMP guidelines
- Handling and tracking of quality and commercial complaints related to medicinal products
- Recall decisions, handle recalls, communicate with manufacturers and authorities
- Decision on the handling of returned products
- Supervising destruction of medicinal products
- Communication with Swiss competent authority
- Evaluation of relevant GDP/GMP documents through the supply chain as required.
- Evaluation of Product quality reviews and Ongoing stability studies
- Qualification of GDP/GMP relevant equipment and facilities or service providers
- Retain samples: the qualified person is responsible that a sample of each released batch of distributed medicinal products being retained.
- Provide any of the above-mentioned services to pharmaceutical companies as contracted with the client

**Supervisory Responsibilities**:

- Instructing and supervising the personnel assigned to storage, distribution, labeling, and packaging of pharmaceutical products. Namely, these are:

- Pharmaceutical Distribution Administrator, and his/her deputy
- GDP Release Officer
- Medical scientist
- Deputy QPs

**Job Requirements**:
Education
- Degree in pharmacy or adequate scientific degree, if several years of experience in GMP/GDP and pharmaceutical products can be demonstrated.

Experience
- Experience in manufacturing medicinal products
- Experience in GDP/GMP environment

Skills/Competencies
- Strong written and verbal communication skills
- Strong interpersonal skills
- Comprehensive knowledge of GMP/GDP Guidelines
- Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
- Superior problem-solving skills
- Able to issue instructions and to take decisions
- Reliable and trustworthy (extract from police records can be required by Swiss authorities)

Capabilities
- Availability 7d/24h

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