Executive, GDP Compliance

Location: Andheri, Mumbai.

(Hybrid working)

About ADVANZ PHARMA

ADVANZ PHARMA is a global pharmaceutical company with the purpose of improving patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on.

Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.

Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network, complements our global operations.

ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.

We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.

About the Role

To ensure the organization abides by the guidelines on Good Distribution Practice (GDP) according to the Quality Management System (QMS) in place, in line with the EU Guidelines on Good Distribution Practice Medicinal Products for Human Use (2013/C 343/01) and local market regulations.

What You’ll Do:  

• To document and verify the global transportation routes taken for all ADVANZ PHARMA products, working closely with the Supply Chain department and external contractors.
• To assess the temperature monitoring/control requirements for each transportation route.
• Periodic review of validated transport routes to ensure compliance and adherence.
• Build and maintain a strong and co-operative relationship with the competent authorities, enhancing the Company’s reputation over time.
• To assist in ensuring that an effective QMS is implemented and maintained.
• To assist in the maintenance of the Company’s Wholesalers, Dealers Authorisation and Controlled drugs licenses.
• Coordinating the supply of Controlled Drugs inventory information to the Home Office.
• To assist in the coordination and execution of any recall operations of medicinal product in accordance with ADVANZ PHARMA procedures.
• To ensure that GDP-relevant customer complaints are dealt with effectively in accordance with Company’s procedures.
• To ensure that adequate and complete records relating to GDP are maintained.
• To ensure contracts are in place between the Company and Contract Acceptors relating to distribution activities.
• To employ due diligence in the discharge of duties and to report to senior management and the relevant UK/EU authority (and relevant local authorities) of any awareness of suspicious events or falsified products.
• To assist during an inspection by the competent authorities.
• To keep up to date with current regulations and industry standards through a program of continuous professional development.
• To take part in the continuous improvement projects as assigned.
• Thrive in an entrepreneurial environment and take accountability for results.
• Embrace challenge and change, applying a growth mindset approach.
• Have a bias for action and fast decision making.
• Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
• Drive the spirit of “One Team” by working collaboratively across all business functions with an open, honest, and respectful cooperation.
• Contribute to making ADVANZ PHARMA a desired place to work.

About You

We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives.

For this role, you will also have the following:

Qualifications: 

• Science Graduate (Chemistry / Biology / Pharmacy (or close equivalent)

Or

• Postgraduate in similar fields.

Knowledge, Skills & Experience:

• Strong experience in handling European GDP compliance and conducting bona fide checks for direct customers and suppliers.
• Working knowledge of QMS, change control, and deviation processes.
• Ability to collaborate effectively with international distribution and supply partners, as well as internal stakeholders.
• Strong organisational skills with the capability to perform under pressure in a fast-paced environment and a team-oriented approach.
• Hands-on experience with SAP Quality modules or VIVA.

• Self-starter, results-driven, stakeholder-centric focus, team player, and accountable.
• Open and adaptable to challenging environments.

• Ability to work with different Global cultures and different time zones.
• Competent with spreadsheets (Excel) and PowerPoint
• Ability to communicate clearly and concisely and use strong writing and verbal skills to communicate facts, figures, and ideas to others.
• A positive and ‘can-do’ approach, biased towards finding solutions and embracing change.
• Inspired by our values of entrepreneurship, speed, and integrity.
• Learning agility and ‘scalability’, with a desire to continuously improve and develop as ADVANZ grows.
• Work collaboratively across all business functions with an open, honest, and respectful cooperation.
• Ability to have fun and thrive in a growing, unique, and inclusive work environment.

Why ADVANZ PHARMA?

The success of any company is driven by its people, and we are no different.

At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment.  We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.

Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients' lives by providing and enhancing the specialty and hospital medicines they depend on.

As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you’ll be empowered to own your work, explore new possibilities, and make things happen.

But there’s more to you – and us – than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles – we have an active ADVANZ PHARMA Women’s Network; almost 40% of our managers are women.

We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.

We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.

To join us on our exciting journey, Apply now! *

*Please include a CV and Cover letter.