Trading Entity Compliance QA Lead

vor 5 Monaten

Zurich, Schweiz Takeda Pharmaceutical Vollzeit

**About** the role**:

- Provide leadership in the development of policy, process and organization to ensure compliant operations
- Perform all the duties and have all rights applicable to the Responsible Person in Switzerland as per Swiss Medic requirements
- Primary contact for local health authorities. Own relationship/communication with the local GDP Authorities, and host External and Internal inspections in Switzerland
- Decide on all pharmaceutical activities in scope of the License
- Provide direction to the organization for the activities falling under the responsibility and decision making mandated by Swiss Medic
- Ensure all requirements to maintain the Wholesale Distribution Authorisation/ Establishment license are met

**How you will contribute**:
Ensure compliance with:

- Federal Act on Medicinal Products and Medical Devices (HMG SR 812.21)
- Medicinal Products Licensing Ordinance (AMBV SR 812.212.1)
- Ordinance on Medicinal Products (VAM SR 812.212.21)
- Good Distribution Practice of Medicinal Products for Human Use (2013/C 343(01))
- Falsified Medicines Directive (2011/62/EU)
- Legal requirements and mandatory due diligence by Swiss firms wishing to engage in foreign trade with medicinal products from Switzerland (Swissmedic I-SMI.TI.18)
- Good Manufacturing Practice (Eudralex vol. 4) in line with oversight of licenced activities associated with contract manufacturing activities, as required per Swissmedic
- Further guidance documents of Swissmedic, as applicable
- Provide expertise in Regulatory Compliance for the products manufactured and traded by Takeda
- The company has given authority to the Responsible Person to perform the required activities as outlined in EU GxP Guidelines.
- Accountable to ensure GxP related activities which support Takeda’s global trading of products are compliance and efficient.
- Authorized to issue directives to the organization in the area of responsibility
- Responsible for the direct technical supervision of the company under the area of responsibility and, in particular, ensure orderly trading in medicinal products
- Ensure appropriate oversight of licenced activities associated with contract manufacturing activities as required per Swissmedic
- Ensure that products-related GMP activities that are delegated or contracted to other Takeda sites or third party contract sites by the RP are controlled through agreements and where appropriate audits
- Ensure deputisation by adequately qualified specialists
- Ensure compliance to the conditions of the Wholesale Distribution Authorisation and to evolving guidelines on Good Distribution Practice (GDP) as defined by the European Commission in OJ 2013/C 343/01 and Swiss Medic’s guidelines
- Ensure that products-related GDP activities that are delegated or contracted to other Takeda sites or third party contract sites by the RP are controlled through agreements and where appropriate audits.

These activities include:

- Ensuring that a quality management system is implemented and maintained
- Ensure contribution to the implementation of a quality risk management system
- Ensure Product Review evaluation is performed in the area of responsibility
- Ensure participation and contribution in the Management Review in the area of responsibility
- Focusing on the management of authorized activities and the accuracy of and quality of records
- Ensuring that initial and continuous training programmes are implemented and maintained; ensuring the conduct of following up trainings
- Coordinating and promptly performing any recall operations for medicinal products
- Ensuring that relevant customer complaints are dealt with effectively;
- Ensuring that suppliers and customers are approved;
- approving any subcontracted activities which may impact on GDP;
- Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
- Keeping appropriate records of any delegated duties;
- Deciding on the final disposition of returned, rejected, recalled or falsified products;
- Approving any returns to saleable stock;
- Ensuring that any additional requirements imposed on certain products by national law are adhered to.
- Deciding independently of the company’s management and may not sit on any of the facilities’ supervisory committees.
- Keep appropriate records and control of any delegated duties and ensure their visibility

Technical/Functional (Line) Expertise
- Meets qualifications to be an Industry Certified Responsible Person (RP) in Switzerland
- Scientific Degree (preferably in Pharmacy)
- Strong knowledge of global regulations relating to GDP, licensing, imports/exports and controlled drug / substance compliance.
- Meets qualifications to be an Industry Certified Responsible Person (RP) in Switzerland
- Scientific Degree (preferably in Pharmacy)
- Strong knowledge of global regulations relating to GDP, licensing, imports/exports

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