Senior Executive Validation

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 a Sr. Executive- Validation.

Main purpose of this role is to ensure process validation activities at the contract manufacturer has been carried out as per current GMP standards and best industry practices in line with Marketing Authorizations (MA).

What You’ll Do:

Maintain and lead the activities for the planning and implementation of any analytical and / or process validation master plans for all MA’s held by the company.

Review and approve process validation protocols and reports for upcoming projects (Development / Technology Transfer / Product Lifecycle Management changes) and ensure SOP is followed throughout the process.

Perform detailed validation gap analysis of process and analytical method validations across the range of products under company portfolio as per relevant SOP.

Highlight any discrepancies / gaps identified in the existing validation, risk assess the identified gaps and propose and lead appropriate remediation activities by liaising with internal / external business partners to close the actions on time.

Support delivery of specific projects as Quality representative for site transfers, API dual sourcing, reformulation and process improvements.

Based on Formulation / production experience, able to take decisions for any issues to be resolved during process validation batches, no. of batches to be taken based on product know-how and type of change.

Should be able to define CPP / CQAs based on formulation knowledge and accordingly review the process validation protocols and reports.

Should be able to review the analytical methods and method validation documents and perform the gap analysis against latest ICH guidelines and pharmacopoeia requirements.

Maintain inventories for all existing process and analytical validation protocols and reports and ensure SOP is followed throughout the process.

Support change control process with impact analysis from validation perspective and suggest tasks as required.

Support QP’s; when required, in their batch release for reviewing key validation documents.

To ensure effective communication is maintained with internal customers & external manufacturers.

To review the existing procedures and do the necessary improvements needed in Validation Summary document process.

To provide the support in drafting the risk assessments for the issues logged in the risk register

To provide the support in the preparation of monthly metrics and present on behalf of the team wherever needed.

Provide support during inspection by competent authorities and / or during the customer audits.

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:

Must have significant experience in analytical method development and validation for regulated and unregulated markets.

Sound working knowledge of all relevant GMP regulations.

Knowledge, Skills & Experience:

Significant experience of working in an equivalent role (Formulation development / QA / Production / Regulatory CMC) within a pharmaceutical company handling the following:

Process validation

Analytical validation

Microbiological / Sterile process

Manufacturing of batches

Good understanding of analytical techniques and relevant pharmacopeia requirements

Experience in management of third-party contractors (CMOs/Contract testing labs)

Knowledge of electronic document management systems and their use in a regulated environment.

Good knowledge of validation guidelines including ICH Q2 and Annex 15 of EU GMP Guide.

Knowledge of technical aspects of product manufacture including quality control and compliance.

Ability to check, analyze and investigate scientific data and information provided in the registered document.

Proactive nature with solution finding skills and abilities.

Excellent interpersonal, communication, organizational skills, and attention to detail.

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.

*Please include a CV and Cover letter.