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Responsible Person - QA Manager

Switzerland · Full-time

About The Position

Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.

As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live.

Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve.

We are a dynamic, fast-paced company, operating in over 25 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us !

The Holder or Applicant of a Swiss establishment license for medicinal products must have a suitable Responsible Person/”Fachtechnisch verantwortliche Person” (RP/”FvP”) in charge. The position is requested for all pharmaceutical companies engaging in trade abroad by law (Medicinal Products Licensing Ordinance (MPLO), art. 21. The RP/”FvP” must be able to execute his/her responsibility, understand the Swiss GMP/GDP requirements and meet regulatory compliance. The Deputy takes over the duties and competencies of the Medison RP, in case of absences of the latter.

 The position can be full time or part time 80 %-100%.

Responsibilities

  • Execute close, expert supervision within the firm and ensure that safety and product integrity is maintained at any time.
  • Carrying out the direct technical supervision of the facilities and ensuring orderly trading in medicinal products according to Art. 23 of the MPLO.
  • Ensure deputization by adequately qualified specialist
  • Issuing instructions within her sphere of activity.
  • Notifying Swiss medic if the facilities cease operations.
  • Deciding independently of the company’s management.
  • Overseeing the company Quality Management System (QMS) and ensuring the compliance to the Quality system requirements.
  • Maintaining and approving Quality system procedures.
  • Ensuring the RP or deputy is always accessible by Swiss/Cantonal/Regional Authorities. The coordinates of both should be known during and outside of business hours. In case of a change of the RP, the old RP remains responsible, until the new RP has been listed in the Operational Authorizations (according to Swiss medic requirements and contractual conditions).
  • Ensuring that the manufacturer of a product traded by Medison has a Manufacturing Authorization of a country for which the GMP control system is considered equivalent by Switzerland, or which guarantees that the medicine is manufactured according to GMP rules as valid for Switzerland (for example: by requesting copies of relevant licenses, such as the Company License and GMP Certificate).
  • Ensuring that Technical Agreements or Quality Agreements between the company and Distributors have been established, defining the responsibility regarding the quality of the product for each party.
  • Ensuring adherence to any trade restrictions as laid out within 812.21 Swiss Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA).
  • Keeping the Deputy RP informed, and as appropriate the Deputy RP keeps the RP informed. See corresponding Job Descriptions.
  • Ensuring training per EPM-SOP-QA-002, Employee Training is conducted and documented.
  • Ensuring Good Documentation Practices are maintained.
  • Ensuring that the customer will be provided on each delivery with details of the original manufacturer and the original batch number of the merchandise delivered.
  • Forwarding to the customer or the supplier all information provided by any supplier or customer that pertains to the quality and safety of the medicinal product or is relevant for the authorities.
  • Ensuring operations of an effective procedure for the batch recall of medicinal products.
  • Collect and preserve documents that are appropriate for proving the pharmaceutical quality of the medicinal products procured.
  • Collect and preserve documents that provide at least the transaction dates, quantity, batch number, expiry date and precise description of the medicinal product plus the name and address of the supplier and customer.
  • Have a robust procedure in place, and provide documented evidence, to regularly qualify the supplier and customer.
  • Ensure and provide documented evidence that supplier and customer are authorized to carry out the relevant activities and comply with the in Switzerland relevant standards of Good Manufacturing and/or Distribution Practice (EU/PIC/S-GMP and EU-GDP).
  • Ensure and provide documented evidence that, including during transport, the necessary storage conditions remain within the limits determined by the manufacturer or stated on the packaging.
  • Verify the supply chain of finished products back to the original marketing authorization holder/manufacturer and make sure that all companies involved in the supply chain worked in compliance with the relevant standards of Good Manufacturing and/or Distribution Practice in Switzerland (EU/PIC/S-GMP and EU-GDP).
  • Immediately inform the competent authority and the MAH (if licensed) of any medicinal products they identify as falsified or suspect to be falsified. This is not only applicable for products they purchase, but also for products they are offered and which they suspect to be falsified.
  • Have in place an effective procedure for any recalls of medicinal products needed.
  • Ensures inspection readiness
  • Carries out any other duties that maybe reasonably required and assigned to you by your manager
  • Works with QA Director to ensure Medison is compliant with latest regulatory and pharma trends related to GMP and GDP
  • Participates in designing, implementing, maintaining, and improving quality system. Ensure the QMS is compliant to regulatory requirements
  • Participates in designing, implementing, maintaining, and improving quality system. Ensure the QMS is compliant to regulatory requirements



Requirements

  • Education / Knowledge
  • Master’s degree in science or equivalent
  • At least 5 years’ experience as RP/FvP ideally for a Trade Abroad License
  • GDP and GM knowledge and experience
  • Excellent written and verbal communication skills
  • Fluent German and fluent English
  • Auditing experience – certified auditor is a plus
  • Excellent interpersonal skills and ability to successfully maintain professional and trusting relationships
  • Works effectively in highly dynamic and changing environments, displays agility.
  • Ability to work with anyone (flexible personality) horizontally and vertically across the organization with a demonstrated ability to interact professionally, to influence, and to manage conflict/differing opinions with the ability to drive solutions
  • Strength in critical thinking, problem solving, and decision making
  • Very strong organizational abilities