Job title : Digital Quality Expert
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally .
Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting.
At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com .
About the Role:
We are looking for a motivated GxP Digital Quality professional (8-10 years) to join our Hyderabad, India team as Project Support — Digital Quality . In this role, you will contribute to the execution and maintenance of Digital Quality standards, supporting compliance with global regulatory requirements and Opella's internal procedures.
You will work as part of a cross-functional team — learning from experienced colleagues, contributing to validation activities, and helping ensure that digital solutions are compliant, validated, and audit-ready.
This role is for someone who takes ownership of their tasks , is eager to grow, and thrives in a collaborative environment where quality is everyone's responsibility.
What You Will Do
1. Quality Documentation Support
Handle document management: Assist in maintaining GxP-relevant Digital Quality Policies, Standards, SOPs, and Work Instructions — ensuring they are accurate, current, and practically applied.
Contribute to lifecycle management: Help manage controlled documents across areas including CSV/CSA, Data Integrity (ALCOA+), Cloud/SaaS governance, and Electronic Records/Signatures.
Keep records current: Support Periodic Reviews and system lifecycle documentation in alignment with corporate and regulatory requirements.
✅ 2. Validation Support & Risk Awareness
Perform validation activities: Support the planning and execution of CSV activities for projects and operations, contributing to fit-for-purpose documentation delivered at pace.
Contribute to quality oversight: Assist in Computer System Validation (CSV) activities, including preparation and review of quality notifications under guidance.
Collaborate with project teams: Work alongside engineering, IT, and operations to support system design, testing, and release activities.
Apply risk-based thinking: Learn and apply risk-based approaches to validation decisions, documenting rationale clearly for team review.
Manage validation deliverables: Assist in preparing and reviewing documents such as URS, Functional Specs, UAT reports, Validation Summaries, and Authorization for Use (AFU) — under the guidance of senior team members.
Handle deviation and change management: Assist in tracking validation-related deviations/CAPAs and change controls for validation impact.
Contribute to continuous improvement: Identify and flag inefficiencies in validation processes, templates, and tools — and bring ideas to fix what slows things down.
3. Cross-Functional Collaboration & Learning
Partner with IT/Digital and operational teams: Provide GxP support during system modernization projects, teaming up for Opella's success.
Engage with SMEs: Collaborate with Cybersecurity, Data Privacy, and Internal Audit colleagues to understand and apply unified compliance requirements.
Support training delivery: Assist in developing and delivering training materials on Digital/GxP policies, Data Integrity, and Validation best practices — helping build a strong quality culture.
4. Audit & Inspection Support
Perform GxP Periodic Review cycles: Support scheduling, documentation, evidence collection, and CAPA tracking under senior oversight.
Maintain validated state: Contribute to Change, Incident, and Problem Management activities to sustain the validated state of regulated systems.
Support third-party management: Assist in maintaining vendor inventories, assessments, and quality agreement documentation.
Contribute to audit readiness: Help prepare evidence packages and support stakeholder coordination for audits and inspections.
Learn from inspections: Participate in Health Authority inspection preparation (FDA, EMA, MHRA, etc.) as a supporting team member, building toward SME capability over time.
Support CAPA activities: Assist in CAPA development and effectiveness checks for observations related to digital quality governance.
About You:
We're not just looking for a resume — we're looking for potential, character, and culture fit . You bring foundational expertise and the mindset of a Challenger: curious, bold, and driven to make things better.
Experience, Education & Skills
7-10 years of experience in GxP Digital Quality and Compliance, with exposure to digital systems and validation.
QA Foundations: Understanding of test strategy, validation lifecycle management, and the GxP aspects of digital systems.
Tooling Familiarity:
️ Jira & Xray: Basic experience using Jira/Xray for test management, including test plans, executions, and traceability matrices.
️ Atlassian: Familiarity with Jira and Confluence workflows to support compliance processes.
️ Compliance Systems: Awareness of tools such as ServiceNow, Veeva Vault, or equivalent document management systems.
Regulatory Awareness: Working knowledge of Annex 11, 21 CFR Part 11, IT General Controls (ITGC), and ALCOA+ data integrity principles.
Exposure to GxP supplier qualification activities is a plus.
Growth mindset: Eager to learn, ask questions, and develop expertise in a fast-paced, cross-functional environment.
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.
www.opella.com/en/careers
