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.
- 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.
- 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-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 firstname.lastname@example.org