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Quality Assurance Responsible Person/Qualified Person

Eingestellt von Edelway

Gesuchte Skills: Network, Engineering, Client

Projektbeschreibung

The AKKA Technologies Group is a leading international Engineering and Technologies services company scattered in more than 20 countries around the world (Europe, Asia, Africa, America and Middle East) with over 15,000 employees and an annual turnover of 1.2b EUR.

Edelway is a Pan-European Life Sciences professional services company with over 750 Consultants.

We recently joined forces with AKKA Technologies Group to develop a wider offer to our global clients.

On behalf of our global pharmaceutical client based in Zurich we are actively looking for a Quality Assurance Responsible Person/Qualified Person to join them on a long term basis.

Contract: Permanent or Freelance with Edelway
Start: ASAP

The role:

Provide leadership in the development of policy, process and organization to ensure compliant global operations

Perform all the duties legally and have all rights applicable to the Responsible Person in Switzerland described in art. 5, art. 10, art. 14 and art. 15 of the Medicinal Products Licensing Ordinance (SR 812.212.1).

The RP must be able to execute his/her responsibility, understand the Swiss GMP/GDP requirements and meet regulatory compliance.

Authorised to decide on all pharmaceutical activities to ensure safe processes of trading pharmaceutical products in foreign countries.

Perform final decision on whether a pharmaceutical product can be traded

Provide direction to the organization for the activities falling under the responsibility and decision making role of the Responsible Person

Ensure all requirements to maintain the Trade License

You will:

Provide expertise in local and global Regulatory Compliance for the products manufactured and traded

Perform all the duties and have all rights legally applicable to the Qualified Person/Responsible Person in Switzerland

Accountable to ensure GXP related activities which support global trading of products are compliance and efficient.

Provide direction to the organization for the activities falling under the responsibility and decision making role of the Qualified Person/Responsible Person

Ensure all requirements to maintain the Trade Licenses are met. Ensure the Quality Management System is fully implemented and maintained

Ensure necessary authorisations are in place to decide on all pharmaceutical activities to ensure safe and compliant processes of trading pharmaceutical products in foreign countries

Manage inspections, corporate internal and external audits

Ensure 24/7 availability for management of critical events requiring pharmacovigilance, escalation and/or recall, decisions and/or support.

Align with a broad global network of stakeholders, management teams and business unites operating within the Network

You profile:

Scientific Degree (preferably in Pharmacy)

Minimum 10 years' experience in a Quality Assurance/Regulatory Compliance role, including Pharmaceutical or medical device industry essential

GDP, distribution, warehousing and transportation experience

Broad understanding of Supply Chain related topics as well as related risks and global regulatory implications

Fluent English and German (written & oral), additional European languages are a plus

International travel as required up to 25%

If this sound like your next challenge, please send me your updated CV to (see below) and I will contact you shortly for an initial interview.

Projektdetails

  • Einsatzort:

    Zürich, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Edelway

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