Qualified Person (Hybrid Working)

About The Role
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!
Your Key Responsibilities:
Your responsibilities include, but not limited to:

• Provide leadership of compliant and efficient quality processes to support GxP activities at the Country Organisation meeting internal and external stakeholder requirements.
• Streamline and improve quality processes, facilitate quality management, and lead the development of a right first-time, quality culture.
• To perform duties of the Qualified Person in compliance with all applicable GMP regulations and directives.
• To perform the duties of a Responsible Person for Import (RPi) ensuring a system to confirm that the required QP certification is in place for all products imported into Great Britain
• Leading local execution of quality systems including compliance to GxP requirements (requiring knowledge of regulations), global standards/SOP’s and local work practices.
• Responsibility for monitoring compliance of the quality activities/systems owned locally – including metrics, quality review, and self-inspection. Liaise with global quality system owner and where appropriate participate in expert networks or work with Centres of Excellence.
• Perform routine risk/impact evaluations associated with product-based decisions or the quality system and participate in escalation situations
• Investigate, manage, and actively resolve quality investigations as needed e.g. deviations, complaints, CAPA at the country organisation (where necessary in conjunction with nominated third parties) to minimise the impact on product availability and sales
• Perform tasks related to quality compliance/governance depending on individual experience. This could involve product launch evaluations, product divestments, quality oversight, MAH responsibilities, regulatory updates, development of documents such as site master file or business continuity plan, metrics review, quarterly leadership presentations or acting as a single point of contact for e-compliance, data integrity, document management
• Work with the country organisation business franchises/brands to provide direction and support for all quality / GMP matters. Provide GxP education and training to others in the team and across the CO.
• Act as a role model for Sandoz Values and Leadership Behaviours, taking positive action to strengthen quality culture and awareness
  

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
What you’ll bring to the role:

• More than 5 years of Experience in the pharmaceutical industry, GxP knowledge
• Working experience and knowledge of MHRA guidelines
• Detailed knowledge of GMDP requirements relating to manufacturing, packaging, licensing, release, and post-market responsibilities.
• Ability to make decisions independently with the right rationale
• Knowledge of process improvement techniques. Development of quality systems and/or processes
• Good working knowledge of problem-solving and evaluation techniques.
• Duties of a Qualified Person
• Duties of a Responsible Person for Import (RPi)
• Demonstrated technical and GDP knowledge and experience to fulfill the duties of a Responsible Person (RP)
• Demonstrated technical and GDP knowledge and experience to fulfill duties of RPi
  

You’ll receive:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)
#Sandoz
Division
SANDOZ
Business Unit
NON-NVS TSA QUALITY STO
Work Location
Frimley / Camberley
Company/Legal Entity
Sandoz Limited
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No