Job Description
Office-based | Oncology
The successful candidate will be the Responsible Person and Quality Lead for the UK. You will have full accountability for all aspects of the systems and compliance. You will also serve as the primary point of contact with regulatory authorities, customers, and third-party contractors regarding QA, GDP and RA related activities.
Company Overview:
Our client is an international biopharmaceutical company, who are passionate about promoting health and wellbeing for all by developing a portfolio of innovative, next-generation products.
* Knowledgeable and supportive management team.
* Patient-centric and increased treatment accessibility focus.
* Competitive starting salary and extensive benefits package.
Job Overview:
* Implementation and maintenance of the Quality Management System (QMS), including SOP generation and review, ensuring compliance with GDP regulations
* Provide the Leadership Team with regular reports regarding the Company’s Quality KPIs, including CAPA plan
* Deviation and change control management, training, outsourced activities, and self-inspections
* Conduct supplier checks, approvals and audits, ensuring adherence to the relevant GDP/GMP standards.
* Ensuring the correct GDP training programmes are rolled out to both new starters as well as existing employees within the business.
* Line management of QA/RA Associate with defined delegation of QA and RA responsibilities, keeping appropriate records of these delegated duties
To be successful:
* A bachelor's degree in pharmacy, chemistry, or other related field, with a strong understanding of GMP and GDP principles
* Minimum of three years’ experience as a Responsible Person in a pharmaceutical environment
* Previously named as an RP/RPi on a WDA licence.
* Accomplished and experience in conducting internal audits and hosting regulatory inspections
* Excellent knowledge of EU & UK GDP, GMP, and regulatory requirements for pharmaceutical products
* Excellent communication, organisational and leadership skills
How to apply:
If you like the sound of this opportunity and you’re ready to take the next step in your career, we would love to hear from you! Please Apply now via the website or contact Elaine Plunkett on 01225 336 335 for more information.
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