Responsible Person / Fachtechnisch verantwortliche Person

Responsible Person / Fachtechnisch verantwortliche Person

Zug, Switzerland (hybrid role: 3 days office, 2 days home per week)

Salary: Competitive + Benefits + Bonus

Duration: 12-month fixed term contract

If you are an agile, committed and detail-oriented pharmaceutical Quality professional, with progressive experience gained in Swiss MAH/Swissmedic Establishment Licence companies, then we want to hear from you.

Join us to help improve peoples' lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 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, Spain, Germany, China, 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.

About the role:

As the Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP), you will exercise the direct technical supervision and control over Atnahs Pharma Switzerland AG, Switzerland (Atnahs CH) and assure that medicinal products and Controlled Substances are handled in line with applicable regulations.

The Responsible Person has the competence to perform all duties and has all rights of the Responsible Person as per the Swissmedic requirements described in Art. 17 and Art. 23 of the Medicinal Products Licensing Ordinance (SR 812.212.1).

The department has an ethos of continuous improvement. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

Main responsibilities & duties:

• Ensure authorised 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).
• Act as primary contact for local health authorities: own relationship with local GDP authorities, and host inspections in Switzerland. If the situation requires, the RP should be continuously contactable
• Assure 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
• Ensure that medicinal products are supplied in accordance to the rules of Good Manufacturing Practices and Good Distribution Practices and operations are safe
• Make the 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 that are deemed 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
• Retain general and batch-specific documentation for each batch released for trade (with respect to release to the market)
• Ensure that all documents that carry the date, quantities, batch number, and exact description of the medicinal product, name, and the address of the vendor, carrier, and recipient are retained
• Ensure that the traceability of purchase and sales activities is guaranteed
• Ensure 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
• Maintain 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 Product Quality Reviews (PQRs)
• Review and approve any GxP or regulatory documents as required
• Using the principles of Quality Risk Management, lead Quality Investigations root cause analysis meetings, ensuring appropriate Corrective and Preventive actions have been assigned
• Review and update Quality & Technical Agreements with Suppliers and Service Providers
• Where required, undertake the Quality review and approval of SOPs, master GMP-related documentation, batch manufacturing records, validation protocols, analytical specifications, change requests, quality reviews, and planned changes in accordance with procedure
• Maintain up to date knowledge of regulatory requirements, including GMP/GDP, and advise colleagues, business partners & management of implications of current and new requirements
• Actively identify and support site continuous improvement projects
• Ensure that Drug Intermediate, API, and Drug Products are handled according to the current GDP

About you:

Candidates with experience of working in quality assurance or regulatory affairs (CMC, authorization procedures) within the Swiss pharmaceutical industry, should have the skills and experience required for the role. We are also looking for:

• Degree in life sciences, e.g. Pharmacology, Pharmaceutical Science, Medicine, Biology, or Natural Science
• Experience of working in the Swiss pharmaceutical industry (Marketing Authorization Holders/Holders of Swissmedic Establishment Licence)
• Significant experience within QA, creating and/or reviewing policies and procedures, internal auditing, reviewing deviations, change control requests, CAPA etc.
• Proven experience hosting and supporting regulatory inspections
• GxP awareness
• Excellent time management skills, the ability to multitask and see the big picture
• Reliable and resilient individual, who is not afraid to challenge at all levels
• Enthusiastic, highly motivated and a growth mindset
• Positive attitude and flexible approach to work
• Systematic, calm and a logical thinker
• Excellent communication skills both written and oral with the ability to forge good working relationships with internal and external customers
• Fluent German language and full professional proficiency in English
• Good command of French language

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

By applying for this role, your details will be sent to Ortolan People, who are acting as consultants for the hiring company. Ortolan People are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.