Quality Assurance Manager RP-i

You will like

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.

You will like

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  

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