Responsible Person

vor 2 Wochen

Baar, Zug, Schweiz Medison group Vollzeit

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.

Responsibilities
  • Execute close, expert supervision within the firm and ensure that safety and product integrity is maintained at any time.
  • Carry out the direct technical supervision of the facilities and ensure orderly trading in medicinal products according to Art. 23 of the MPLO.
  • Ensure deputization by adequately qualified specialist.
  • Issue instructions within her sphere of activity.
  • Notify Swiss medic if the facilities cease operations.
  • Decide independently of the company's management.
  • Oversee the company Quality Management System (QMS) and ensure compliance with the Quality system requirements.
  • Maintain and approve Quality system procedures.
  • Ensure the RP or deputy is always accessible by Swiss/Cantonal/Regional Authorities.
  • Ensure 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.
  • Ensure that Technical Agreements or Quality Agreements between the company and Distributors have been established.
  • Ensure adherence to any trade restrictions as laid out within 812.21 Swiss Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA).
  • Keep the Deputy RP informed, and as appropriate the Deputy RP keeps the RP informed.
  • Ensure training per EPM-SOP-QA-002, Employee Training is conducted and documented.
  • Ensure Good Documentation Practices are maintained.
  • Ensure that the customer will be provided on each delivery with details of the original manufacturer and the original batch number of the merchandise delivered.
  • Forward 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.
  • Ensure 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.
  • Have a robust procedure in place 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 relevant standards of Good Manufacturing and/or Distribution Practice.
  • Ensure and provide documented evidence that, including during transport, the necessary storage conditions remain within the limits determined by the manufacturer.
  • Verify the supply chain of finished products back to the original marketing authorization holder/manufacturer.
  • Immediately inform the competent authority and the MAH of any medicinal products they identify as falsified or suspect to be falsified.
  • Have in place an effective procedure for any recalls of medicinal products needed.
  • Ensure inspection readiness.
  • Carry out any other duties that may be reasonably required and assigned to you by your manager.
  • Work with QA Director to ensure Medison is compliant with the latest regulatory and pharma trends related to GMP and GDP.
  • Participate in designing, implementing, maintaining, and improving the quality system.
Requirements
  • Master's degree in science or equivalent.
  • At least 5 years' experience as RP/FvP ideally for a Trade Abroad License.
  • GDP and GMP 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.
  • Ability to work effectively in highly dynamic and changing environments.
  • Ability to work with anyone across the organization.
  • Strength in critical thinking, problem solving, and decision making.
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