Quality Auditor

ROLE OVERVIEW

We are seeking a highly skilled Quality Auditor to play an integral part in implementing the global audit program and conducting international QA audits.

The role involves exciting opportunities to develop skills across a broad range of therapeutic areas working within a multi skilled team with opportunity to input into planning and conducting of audits and best ways of working. Training and development opportunities are embraced to enhance the role and the individual.

As the Quality Assurance Auditor your responsibilities will include:

·         Managing full life-cycle of GMPD audits from planning to conducting audits.

·         Auditing CMOs, suppliers, API, warehouses, distributors and more.

·         Conducting international audits.

·         Being involved in strategic projects.

This role can be either fully office-based in our great offices or part home-based/part office-based.

COMPANY OVERVIEW

Since our founding by physician entrepreneurs in 1952, the Mundipharma network of Independent Associated Companies (IACs) has served the needs of patients and healthcare providers around the globe by providing novel medicines that address unmet medical needs. The Mundipharma network of independent associated companies has a presence in more than 120 countries worldwide including over 30 in Europe.

The network’s autonomous structure allows each independent associated company to concentrate and tailor activities to its own market, in particular the specific needs of the patients and physicians it serves. It can also more easily keep pace with local regulatory and healthcare sector developments. At the same time, having ready access to the combined scale, development and commercial expertise of the wider network is enormously beneficial.

We are a values-led business which has resulted in our great working environment and culture giving our staff the opportunity to deliver high-performance and make a difference to every patient.

Mundipharma International Technical Operations Limited (MITO) was established in 2017 and provides centralised quality support for our IACs. In addition to the quality function, other functions include Supply Chain Assurance, Research QA, Security Operations and Technical Support. MITO also includes the Finance, Strategic Sourcing, Technical Services, Supply Chain Optimisation and HR.

EXPERIENCE

·         Experience in conducting external GMDP audits.

·         Experience in full life-cycle of audits.

·         Quality Background within the pharma industry, with internal audit experience as a minimum.

SKILLS

·         Efficient report writing.

·         Ability to communicate at all levels effectively.

·         Ability to apply risk management principles and knowledge of processes in the assessment of GMDP compliance for low/medium risk and less complex product types.

·         Good organisation/co-ordinating skills.

·         Effective time management and prioritisation skills.

·         Able to work in isolation & within a team in a collaborative manner.

·         Effective Auditing Skills.

ACADEMICS / ACADEMIC QUALIFIATIONS

·         Ideally lead Auditor Qualification, or some audit experience, training can be provided to achieve this qualification for a suitable candidate.

To discuss the role in more detail please feel free to contact MITO HR by email to: TechnicalOperationsRecruitment@mundipharma-to.com