Responsible Person (GDP) - Head of Quality

Main tasks and responsibility:

To act as under article 52 (a) of German Medical Act as the Responsible Person named on the Whole sale license of the business in undertaking the following tasks listed below:

The Responsible Person position is a function that ensures the continued compliance of the business with the EU GDP guideline and the local law and regulatory requirements as applicable in Germany.

The Responsible Person should ensure the following main tasks and responsibilities are being taken and fulfilled by the business as a wholesaler:

The Responsible Person is named internally and communicated to the local regulatory authority in Germany:

- Overseeing and ensuring that a quality management system is implemented and maintained.

- Focusing on the management of authorised activities and the accuracy and quality of records.

- Approving the initial and continuous training programme for all personnel involved in GDP and medicinal products distribution activities.

- Participating into any recall operations of medicinal products in accordance with the approved SOPs within the company.

-Ensuring that relevant customer complaints are dealt with effectively.

- Overseeing the qualification and approval of suppliers and customers.

- Assessing and authorising the return to saleable stock or destruction of any returned medicinal products.

- Assessment, review and release into saleable stock of medicinal products following certification by the Qualified Person.

- Approving commercial and technical contract/agreements between the Contract Giver and the Contract Acceptor related to respective responsibilities for GMP- manufacture, testing, packaging and GDP - wholesale distribution and/or transportation of medicinal products.

- Communicating with the Regulatory Agency on behalf of the business in relation to any GDP, Regulatory or administrative matters.

- Overseeing the periodic review and monitoring of the current medicinal products stock to ensure adequate management and dispatch based on FEFO rule.

- Overseeing and ensuring that initial and periodic checks on customers are performed in accordance with the company approved SOPs.

- Overseeing decisions and approval of risk assessments/investigations/change requests related to general GDP or product related processes/activities: quality/regulatory/safety/efficacy of medicinal products quarantine or disposal of returned, rejected, recalled or falsified products.

- Taking part in the change control committee and periodic Quality Management Review meetings, participating to all company GDP and PV training in accordance with the training plan.

- Hosting and providing support to GDP inspections by clients and regulatory authorities.

- Ensuring that the customer complaints are monitored, assessed and in accordance with the GDP requirements as documented in the company approved SOPs.

- Ensuring that any additional requirements imposed on certain products by national law are adhered to, as foreseen in Article 83 of Directive 2001/83/EC.

- Maintaining own training file and continuous professional development as documented in the company SOPs and in line with the regulatory requirements in connection with the roles and responsibilities defined in the job description.

- Ensure office presence at least every week and made herself/himself as and when required.    

Requirements profile:   LifeScience BSc and relevant GMP experience and knowledge related to the RP legal requirements and

Personal obligations:   Follow the company procedures and processes and comply with the local law and any legal requirements in connection with the position defined in the present job description