6 days old

Senior Quality Assurance Representative and Responsible Person

Basingstoke, England RG21 4
Senior Quality Assurance Representative and Responsible Person
Europe; Middle East; Africa
United Kingdom
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.
A fantastic opportunity has arisen as Senior Quality Assurance Representative and Responsible Person at Lillys UK Hub Headquarters in Basingstoke.
We are looking for someone who has experience working in a multinational pharmaceutical company with a focus on pharmaceutical product distribution. This is a critical role with accountability. Your pharma experience and proven experience dealing with the health authorities will hold you in good stead for this role. Read on for more details.
1.Responsible person listed on the Companys Wholesale Distribution Authorisation (WDA) according to the requirements of the Medicines and Healthcare products Regulatory Agency (MHRA).
2.Ensuring that an appropriate Quality Management system is in place and maintained as per Lilly Global Quality Standards and local MHRA requirements.
3.Active collaboration with the Regional Product Quality team to advice, inputs and guidance and involvement on any regional or cross functional project.
Key responsibilities:

Responsible Person (RP) Legal responsibilities
Perform duties of RP as documented by the MHRA and maintains the Wholesale Distribution Authorisation.
Communicates new policies and legal requirements issued by the local health authority to the Affiliate Lead Team and relevant stakeholders.
Ensures the appropriate communication to the local health authority of any reportable event related to product quality and product shortages.
Keep the Affiliate inspection ready at all times
Ensures that third party quality agreements are in place.
Ensure together with the Affiliate Medical Director full compliance for GMP promotional materials.
Quality Management
Responsible for the operation and continuous improvement of the Product Quality Management System bases on Global Quality standards and local regulatory requirements.
Maintenance of the Product Quality SOP system.
Training of the Affiliate personnel on Product Quality SOPs and processes.
Ensure Notification to Management process is effectively used and escalate as appropriate.
Manage all quality issues, ensuring they are investigated, documented and appropriate CAPA is identified.
Quality oversight of distribution activities, including physician samples.
Quality oversight of GMP promotional materials.
Ensure a self-inspection program is in place and inspections are carried out at appropriate regular intervals.
Recall coordinator.
Responsible to maintain the process in place for managing falsified medicines and, product complaints.
Responsible for the change management and deviation system.
Ensure appropriate external third party oversight by performing assessments, monitoring performance and quality governance incompliance with Global Quality Standards.
Support new product launches.
Ensure relevant permits and import/export documentation are obtained for controlled drugs.
Science graduate or equivalent,
Experience in the application of Good Distribution Practice (GDP) regulations. Pharmaceutical manufacturing experience would be advantageous.
Knowledge of the products traded under the licence,
Knowledge of the role of the MHRA & HPRA in the licencing of medicines,
Knowledge of relevant UK, IE & EU legislation,
An understanding of the role of the Home Office regarding controlled drugs
Proven experience effectively liaising with Supply Chain, Marketing, Regulatory Affairs, Medical, Patient Safety stakeholders within a pharma company
Excellent communication skills: Oral and written
Influence: Strong interpersonal and negotiation skills
High attention to detail and accuracy
Business and customer/patient focused
Resilience and tenacity
Teamwork and embrace diversity
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  • Science
Posted: 2019-10-07 Expires: 2019-11-07

As one of the oldest continuously operating companies in the United States, we are proud of all the innovative work we’ve accomplished for the last 140 years to improve global health.

We are looking forward to an even more successful future in which continued innovation and contributions from top talent in all areas of our organization will be critical.

Are you looking for a way to make life better for people around the world? We have opportunities in many areas of our organization. Please use the search feature to see the wide scope of our positions.

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Senior Quality Assurance Representative and Responsible Person

Basingstoke, England RG21 4
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