ADVANZ PHARMA
Website:
advanzpharma.com
Job details:
Job Title: Specialist, Validation
Location: Andheri, Mumbai (Hybrid working)
About the Role
As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking a Specialist, Validation to join our Quality team.
This role is responsible for overseeing and ensuring that process and analytical method validation activities conducted by contract manufacturers comply with current GMP standards, applicable regulatory requirements, Marketing Authorisations (MAs), and industry best practices. The role also involves identifying validation gaps, assessing associated risks, driving remediation activities, and supporting quality improvement initiatives.
What You'll Be Responsible For
- Lead planning and implementation of process and analytical validation master plans for company products.
- Review and approve validation protocols and reports for new projects, including development, technology transfer, and product lifecycle management changes.
- Conduct validation gap assessments for process and analytical methods and ensure compliance with relevant SOPs.
- Identify validation gaps and risks and coordinate remediation activities with internal teams and external contract manufacturers.
- Support quality activities for site transfers, API dual sourcing, reformulation, and process improvement projects.
- Review validation batches and provide technical input based on formulation and production experience.
- Define CPPs and CQAs based on formulation knowledge and review validation protocols and reports accordingly.
- Review analytical methods and validation documents against the latest ICH guidelines and Pharmacopoeial requirements.
- Maintain records and inventories of existing process and analytical validation protocols and reports.
- Support change control activities by conducting validation impact assessments and recommending required actions.
- Support QPs in reviewing key validation documents during batch release, where required.
- Maintain effective communication with internal stakeholders and external contract manufacturers.
- Review and improve existing procedures related to the Validation Summary Document process.
- Support preparation of risk assessments for issues recorded in the risk register.
- Stay updated on changes in regulatory guidelines and ensure applicable procedures and systems remain compliant.
- Support preparation and presentation of monthly validation metrics and team KPIs.
- Participate in quality improvement projects.
What We're Looking For
We're looking for ambitious, resilient, and commercially minded professionals who are passionate about improving patient outcomes and driving business growth.
For this role, you will also have the following:
Qualifications:
Knowledge, Skills & Experience:
- 8–10 years of pharmaceutical experience, including 3 years of exposure to sterile manufacturing.3 years of exposure to sterile manufacturing.
- Pharmaceutical Manufacturing & Validation: Strong understanding of pharmaceutical manufacturing processes and validation principles.
- GMP & Regulatory Knowledge: Good knowledge of GMP requirements, regulatory expectations, and compliance standards.
- Annex 1 & Sterile Manufacturing: Sound understanding of Annex 1 requirements and aseptic/sterile manufacturing practices.
- Process & Analytical Validation: Experience in process validation, analytical method validation, validation protocols, reports, and gap assessments.
- Quality Systems: Knowledge of quality systems, SOPs, change controls, deviations, CAPA, risk assessments, and continuous improvement.
- Manufacturing Experience: Hands-on exposure to manufacturing of dosage forms such as tablets, liquids, and sterile products; biosimilar experience is an advantage.
- Technical & Analytical Skills: Ability to review validation documents and assess compliance against ICH guidelines and Pharmacopoeial requirements.
- Problem-Solving: Strong analytical and problem-solving skills with the ability to identify risks and drive remediation.
- Stakeholder Management: Effective communication and collaboration with internal stakeholders, cross-functional teams, and external contract manufacturers.
- Project Management: Ability to take ownership, manage validation activities, and drive projects and actions to completion.
- Leadership & Accountability: Strong ownership, accountability, initiative, and ability to drive operational improvements.
Why join ADVANZ PHARMA?
- At ADVANZ PHARMA, our purpose is clear: improving patients' lives by increasing access to medicines that matter. We are a fast-growing international pharmaceutical company where employees have the opportunity to make a tangible impact, take ownership, and contribute to meaningful work every day.
A Place Where You Can Grow
We foster a culture built on trust, collaboration, inclusion, and continuous development. Whether you're expanding your commercial expertise, taking on new challenges, or building your career within a growing organisation, you'll be supported to succeed.
Entrepreneurial by Nature
Our teams are empowered to make decisions, challenge convention, and create solutions that drive results. We value people who bring energy, accountability, and a desire to make things happen.
A Meaningful Mission
Every role at ADVANZ PHARMA contributes to improving access to important therapies for patients across the globe. The work you do will have a direct impact on healthcare professionals, healthcare systems, and ultimately the patients they serve.
Flexibility and Support for Your Wellbeing
Our agile and flexible working arrangements, paired with a comprehensive compensation and benefits package, are designed to support your health, career aspirations, and work-life balance.
Rewards & Benefits
We are delighted to offer a comprehensive package designed to support the health, well-being, and professional growth of our employees.
Global benefits:
- Global recognition program
- Long Service Award
- Employee Assistance program
- Birthday leave
- Wellbeing day
- Volunteering leave
- Compassionate leave
- Agile working [for office-based employees only]
- Work from Anywhere subject to local legislations [for non field based employees only]
Our People Recommend Us
We're proud that 82% of employees in our 2026 engagement survey said they would recommend ADVANZ PHARMA as a great place to work.
If you're looking for an opportunity to combine commercial success with meaningful patient impact, Apply Now!
Click on Apply to know more.
