Deputy Responsible Person

vor 5 Monaten

Zug, Schweiz Atnahs Vollzeit

**Based in Zug, Switzerland - hybrid working**:
**Salary: Competitive + Benefits + Bonus**:
If you are a quality or regulatory professional with a good understanding of the Swiss pharmaceutical industry, then we want to hear from you

**Why Pharmanovia?**:
Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

**Our core behaviours are**:

- We act decisively but we never compromise on quality.
- We keep our promises and do as we say.
- We value our heritage and foster an entrepreneurial spirit.
- We reinvest in our future - in our products, our brands and our people.
- We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, and South Korea.

We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia’s therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

**The role**:

- The Deputy Responsible Person (also called “Stellvertretende Fachtechnisch verantwortliche Person”, Stv FvP) is supporting the Swiss Responsible Person to exercise direct technical supervision and control over Atnahs Pharma Switzerland AG, Switzerland (Atnahs CH) and assures that medicinal products and Controlled Substances are handled in line with applicable regulations.
- Ensure authorized operations are conducted in compliance with the conditions of Swissmedic Establishment License for import incl. release to the market, wholesale, export, and trade in foreign countries, as well as with the License for Controlled Substances, and to Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01).
- In the absence of the RP: act as primary contact for local health authorities: own relationship with local GDP authorities, and host inspections in Switzerland. If situation requires, the Deputy RP should be continuously contactable.
- Assurance that each batch of medicinal product for the Swiss market is in compliance with the specifications and is manufactured according to the Swissmedic Marketing Authorization.
- Ensuring that medicinal products are supplied in accordance to the rules of Good Manufacturing Practices and Good Distribution Practices and operations are safe.
- The Deputy Responsible Person has the competence to perform all duties and have all rights of the Responsible Person as per Swissmedic requirements described in Art. 17 and Art. 23 of the Medicinal Products Licensing Ordinance (SR 812.212.1).
- Decision on the release or rejection of batches for the Swiss market, independent from the company’s management, as per MPLO, Art. 13 and Art. 17.
- Authorised to issue instructions, order any measures he/she deems necessary and if not followed - to escalate it internally and/or to notify Swissmedic.
- Ensure that requirements to maintain the Swissmedic Establishment License and License for Controlled Substances are met.
- Ensure that the import, export and wholesale trading in medicinal products are in conformity with the GDP rules described in Annex 4 and ensure that the legal provisions applicable to medicinal products are observed.
- General and batch specific documentation is retained for each batch released for trade (with respect to release to the market).
- All documents which carry the date, quantities, batch number, and exact description of the medicinal product, name and the address of the vendor, of carrier, and of the recipient are retained.
- Ensure that traceability of purchase and sales activities is guaranteed.
- Ensuring that applicable Atnahs Global Policies and Global SOPs for all GDP/GMP activities are implemented for the local affiliate.
- Perform gap assessments of Global Policies and Global SOPs.
- Maintaining the Swiss Quality Manual and local SOPs, as well as other controlled documents (e.g., Forms)
- Qualification and Approval of Customers, periodic verification of Customer entitlement.
- Evaluation of

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