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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.
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
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik