Responsible Person

Freelance - Responsible Person (52a)


Munich


Blood Plasma Medicine Manufacturer


Ensuring that a quality management system is implemented and maintained.

Managing of authorized activities and the accuracy and quality of records.

Ensuring that initial and continuous GDP training programmes are implemented and maintained.

Coordinating and promptly performing any recall operations for medicinal products.

Ensuring that relevant customer complaints are dealt with effectively.

Ensuring that supplied 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.

Deciding on the final disposition of returned, rejected, recalled, or falsified products.

Having full knowledge of the Licence Holder and the activities that it undertakes.

Ensuring that the Licence Holder is complying with the conditions of the licence issued.

Ensuring that the guidance on Good Distribution Practice (GDP) are complied with.

Ensuring that products are being stored under the correct storage conditions.

Regularly monitoring all named sites.

Receiving reports when tasks are delegated to the Deputy Responsible Person.

Being vigilant, to ensure that falsified medicinal products do not enter the supply chain.

Keeping appropriate records of any delegated duties.

Approving any returns to saleable stock.

Ensuring that any additional requirements imposed on certain products by national law are adhered to.

Assisting with product quality complaints when RP input is required.

Undertaking project work as agreed with the Quality Director.

Advising and assisting any member of QPL staff when requested with GDP related issues.

Maintaining a general awareness of matters relating to Pharmacy and report to any member of senior management, those which may be directly relevant to the company.

Signing on as Responsible Pharmacist for the Registered Pharmacy when required.

Performing Quality Approval of MoD over-labelling orders and approve new or amended specifications.

Partaking in the internal and external audit programs on behalf of Target Healthcare Group

Supporting the Validation and Health and Safety departments.


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