Quality Assurance Manager RP-i

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Working for this global pharmaceutical firm, providing medicine and essential medical products, to people worldwide before, during & after Covid-19. They prioritise emerging markets, partnering with innovative companies to deliver their products to the regions they cannot reach and are renowned for quality in time-critical, temperature-controlled supply chain and logistics and GDP compliance.

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The Quality Assurance Manager RP-i / QA Manager RP-i / Responsible Person RP-i job itself where you will undertake the responsibilities and duties of the 'Responsible Person' as defined within EU Good Distribution Practice Guidelines (GDP) for Medicines for Human Use. 

More specifically:

  • Accountable for the Quality Management System (QMS) by implementing the requirements of EU GDP.
  • Effective management and development of the Quality Assurance team.
  • Maintain knowledge of GDP and logistics developments and emerging regulations to guide the maintenance of the QMS and guide Senior Management.
  • Deciding on the final disposition of stock affected by return, rejection, recalled, on-hold or suspected of being falsified.
  • Proactively lead the simplification of processes whilst ensuring compliance.
  • Contribute to effective service delivery by promoting continuous improvement and good practice
  • Through the principles of quality risk management, identify the key areas for focus
  • Work alongside QA towards meeting KPIs
  • Responsible for new product approval and maintenance of existing products
  • Conduct and support Quality planning, including the audit schedule, third party QTAs
  • Identify and support staff development and learning
  • Responsible for advising business areas on effective management of
    • Risk Assessments
    • Change Control
    • Deviations, Root Cause, CAPA
    • Customer and Supplier Complaints

Plus work closely with QA and Department Managers to

  • Assess the suitability and competence of third-party contractors
  • Validate key equipment to ensure correct installation
  • Validate key processes to ensure correct operations
  • Ensure Customer and Supplier Qualification are performed in a timely manner
  • Ensure equipment is maintained and calibrated
  • Report on deviations from the process, perform RAs and implement CAPAs to continuously improve systems and processes
  • Ensure all activities are recorded clearly, accurately and concisely and that data integrity of these records is maintained
  • Remain up to date in the products handled
  • Identify and deliver company GDP training where required

You will have

To be successful as the Quality Assurance Manager / QA Manager / Responsible Person RP-i you will have attributes in keeping with company ethos – professional, hands-on and results-driven.  You will be motivated to achieve success, but also work collaboratively with their colleagues to achieve the company goals.  The potential candidate will have worked in a similar level role, ideally in a fast-paced, international and highly regulated environment. 

Essential

  • Previous experience in a Senior Quality Assurance role (or similar), preferably within a GDP focussed environment, with a minimum of 3 years’ experience.
  • Qualified Pharmacist or Pharmacy Technician with a breadth of experience including dealing with wholesale suppliers and the requirements of EU GDP.
  • Degree qualified in a relevant pharmaceutical or related subject.
  • Experience of investigating complaints and deviations using previous experience and highly developed problem-solving skills.
  • Strong judgement and analysis skills with the ability to work to deadlines and make rational informed decisions quickly.
  • Excellent organisation and time management skills with the ability to effectively manage conflicting priorities.
  • Ability to provide feedback in a constructive manner.
  • A team player, with excellent listening and communication skills, with the ability to work unsupervised and alone.
  • Understanding the requirement of carrying out EEA and International bona fide customer and supplier checks.
  • Experience of reviewing company procedures, authoring new and/or existing company procedures.
  • Experience of performing Internal Audits and External Audits.
  • Experience of report writing.
  • Proficient in Microsoft Word, Excel, PowerPoint.

Desirable

  • Previously named as RP-i for a minimum period of 1 year.
  • Experience of working across inter-company functions or multi-company roles with increasing responsibilities and leadership skills.
  • A breadth of experience across relevant fields of the pharmaceutical industry giving rise to transferrable skills.
  • Experience of implementing/ using a Learning Management System.
  • Experience of using SAP B1 or SAP e

You will get

As Quality Assurance Manager / QA Manager / Responsible Person RP-i, you will enjoy a highly competitive salary to £60K + Bonus + Package

You can apply

To Quality Assurance Manager / QA Manager / Responsible Person RP-i by pushing the button on this job posting (recommended), or by sending CV in confidence to anthony@macstaff.co.uk  

UK_MS

Permanent
21 February 2021
Manufactucturing/Production
Quality Manager
England, Watford

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