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 / QA Manager / Responsible Person RP 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.
• 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 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.
• 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.
• Previously named as RP for a minimum period of 2 years.
• 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, you will enjoy a highly competitive salary to £60K + Bonus + Package
You can apply
To Quality Assurance Manager / QA Manager / Responsible Person by pushing the button on this job posting (recommended), or by sending CV in confidence to (url removed)
Product Quality Assurance
Complex Problem Solving