Responsible Person / Specialist QA Amgen Sp. z o.o.
Amgen Inc
Lodz, Lodzkie
3 d. temu

You will be named as a Responsible Person on the Wholesale Dealer s Authorisation for Amgen Sp z. o.o. and will have the following responsibilities :

To ensure that the provisions of the licence are observed and maintained including the monitoring, review and implementation of new and emerging legislation.

You will be the prime point of contact for Chief Pharmaceutical Inspectorate (Główny Inspektorat Farmaceutyczny GIF) and other European Regulators as applicable.

To ensure that the operations do not compromise the quality of medicines by ensuring that a robust and workable Quality Management System is in place and maintained to meet regulatory and customer requirements.

To work closely with teams and functions within the organization and Contractors to support incidents and take a proactive approach to providing effective solutions.

To oversee audit of the quality system and to carry out independent audits including the implementation and schedule adherence of a self-inspection programs.

To ensure that adequate records are maintained.

To ensure that all personnel are trained.

To ensure full and prompt cooperation in the event of recalls.

To decide on the product disposition for distribution on the market, approving any returns to saleable stock, returns, rejections, or falsified products.

Responsible for the management and performance of the Quality Management System at Amgen Sp z.o.o., including continuous improvement, quality management reviews, risk management, change control, complaints, nonconformance management and investigation, self-

inspection and generation of quality agreements and close interaction and oversight of the supplier and the contractors.

You will lead, manage and develop the functionality of the entity (LRD ) across good distribution practice (GDP) and continually review ways of working to improve processes and procedures to deliver compliance across the business.

The Ideal Candidate

You will ideally be of graduate pharmacist with extensive knowledge and experience of pharmaceutical legislations and demonstrable leadership capabilities.

You will be an effective team player, with attention to detail and excellent influencing and interpersonal skills. You will have demonstrable ability in building internal and external relationships with the ability to make a positive impact.

You will have excellent problem solving skills and critical appraisal skills and a track record of using strong influencing skills to deliver positive outcomes.

Additionally the candidate should understand the principles and guidelines of good manufacturing practice and how the principles of GDP maintain the product quality throughout the supply chain.

In order to fulfil the requirements of being named as a Responsible Person the ideal candidate should have strong Quality Assurance skills with a minimum of 3 years experience working in a healthcare quality role and / or knowledge and experience related to the distribution of medicinal products and knowledge of the products / dosage forms of the products traded under the licence.

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