Date: 3 Jun 2024 Location: Andheri (East), IN, Mumbai 400 Company: AdvanzPharma
Location: Andheri, Mumbai
(Hybrid working opportunity)

About ADVANZ PHARMA

ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve 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 complement our global operations.
ADVANZ PHARMAs 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
As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for an Executive- Quality Systems.

What Youll Do:

• Execute Complaints investigations in accordance with the defined procedures ensuring that:
  • Complaints are raised in the system.
  • Complaints are investigated to the required standard and that root cause is identified (leading to appropriate CAPA).
  • Complaints resolution is appropriately documented with supporting evidence.
• Liaising with CMOs and relevant stakeholders to ensure that complaints are investigated, resolved and closed in a timely manner.
• Interact with complaints reporter in the course of investigations and communicate the outcome of investigations accordingly.
• Follow up with CAPA owners to ensure that actions are implemented in a timely manner.
• To assist in executing Recalls as required.
• To assist in investigation of deviations when required.
• Creation of Quality related documentation (SOPs, Risk Assessments etc.)
• Carry out internal audits as required.
• Report Quality Systems metrics.
• Other activities as may be required, at the discretion of management.
• 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:

• Minimum Honors Degree in Chemistry, Pharmacy or Microbiology.

Knowledge, Skills & Experience:

• Decent experience of working in a similar role within a pharmaceutical company.
• Ability to use eQMS (eg. TrackWise, Veeva Vault etc.) for Quality Systems management.
• Knowledge of ICH Q9, ICH Q10 and Eudralex- Volume 4 Good manufacturing practice (GMP) guidelines.
• Capable of working to deadlines & remain calm under pressure.
• Good working knowledge of MS Office.
• Well organised with logical & methodical approach to work.
• Excellent communication skills, both oral and written, to include senior management where escalation is required.
• 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, youll be empowered to own your work, explore new possibilities, and make things happen.

But theres 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 Womens 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.