AddressDate: 30 Mar 2024
Location: Andheri (East), IN, Mumbai 400
Company: AdvanzPharma
Job: Senior Executive Stability
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 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
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 Senior Executive-Stability.
What You’ll Do:
- Intimation of stability testing and follow up of stability reports with CMOs.
- Preparation and review of stability protocols for new studies.
- Assuring a suitable stability study number in stability software to every study initiated (On going).
- Ownership of OOS/OOT investigations and ensure that the relevant agency/QP is notified immediately once the results are confirmed.
- Unless otherwise justified, close all stability related deviation within 45 working days.
- Reduction of deviations cycle time in stability.
- Provide support to internal stakeholder by providing requested information on time.
- Prepare risk assessments, justifications, expert statement and RFI response for regulatory submissions.
- Supports CMO's and contract labs in case of problems and arrangement of impurity /other standards.
- Managing the stability database on daily basis.
- Monthly reporting of Stability Metrics to Manager (on-going).
- Review and perform impact assessment on stability management due to change control inside the organisation.
- Participation in allocated internal/external audits (ongoing).
- Negotiations with CMO's and contract labs for quotation applied.
- To be punctual, maintain appropriate dress codes, be polite and courteous to internal and external customers.
- Demonstrate flexibility and willingness to assist.
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:
- Graduate with science background with specialisation in Chemistry/Biology/Pharmacy (or close equivalent) or a post-graduate in relevant field.
Knowledge, Skills & Experience:
- Hands on experience on various laboratory instruments like HPLC, GC in a reputed pharmaceutical company.
- Hands on experience of method validation and transfer activities and review and approval of relevant protocols and reports.
- Has experience of working in a virtual company environment.
- Candidate should have a thorough knowledge of cGMP and GLP and should have a good analyzing and communication skills.
- Candidates having experience in MHRA or USFDA approved companies will have added preference.
- Excellent interpersonal, communication, Investigational skills.
- Decision making & problem -solving skills.
- Knowledge of European Regulations, Guidelines for pharmaceutical products.
- 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.
