Specialist Computerised System Validation (On 6 months Contract)

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 Specialist Computerized System Validation.

What You'll Do:

• To conduct risk & impact assessment to determine the extent of validation.
• To provide the computerized system validation approach to various computerized systems like Identification of Medicinal Product (IDMP), Master Data Management (MDM) system etc. based on GAMP category & risk of computerized system.
• To prepare & review the various validation deliverables e.g. Initial Risk Assessment (IRA), Validation Plan (VP), Configuration Specification (CS), Test Scripts, Requirement Traceability Matrix (RTM), Data Integrity Assessment (DIA), Validation Summary Report (VSR) etc. in line with GAMP 5 & regulatory requirements like EU Annex 11, 21 CFR Part 11.
• To follow Quality Management System (QMS) procedures e.g. change control, deviations etc. during validation of computerized system validation.
• To design Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)/User Acceptance Testing (UAT) test script as per User Requirement Specification (URS) & execute by following good testing practices.
• Should follow Good Documentation Practices (GDP) during preparation & execution of validation documentation.
• To investigate & close the deviation observed during project & execution of test scripts.
• Provide input into project decisions in the assessment and specification of IT requirements.
• To have a strong knowledge about the Regulatory Information Management (RIM) & MDM Systems.
• To attend periodic project meetings & provide the input about the validation aspects as and when required.
• To attend the configuration workshops (for category 4 systems) & assess the requirement of validation.
• Other validation related activities as may be required, at the discretion of manager ITQA/project manager.
• To support data migration & its verification activities e.g. preparation & review of data migration documentation i.e. Data Migration Plan (DMP), Verification Test Scripts & Data Migration Summary Report (DMSR) etc.

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 hold a minimum qualification of bachelor's degree in Life science e.g. Chemistry, Pharmacy or &/ IT.
• Trained in IT to compliance to recognized standard.

Knowledge, Skills & Experience:

• Significant experience of working in a similar role within a global pharmaceutical company.
• Knowledge of GMP with work experience in GMP environment.
• Specialist in IT Compliance (GAMP 5, EU Annex 11, 21 CFR Part 11, MHRA Data Integrity, PICS, ITIL etc.)
• Significant knowledge/experience of QMS.
• Capable of leading the implementation of IT Compliance standards.
• 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.

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

*Please include a CV and Cover letter.