Quality Complaint Management

Opella Healthcare Group; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Opella Healthcare Group seeks a Quality Complaint Management specialist to lead end-to-end handling of product quality complaints from intake through closure. You will collaborate with manufacturing sites, CMOs, and regulatory interfaces to ensure rigorous investigation documentation and timely resolutions.

The role emphasizes data integrity, CAPA assessment, and preparation of metrics for governance reviews, with strong focus on GMP compliance and cross-functional collaboration across global

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, Microbiology, Biotechnology, or related scientific discipline.
• Experience in Quality Assurance, Quality Systems, Complaint Management, Manufacturing Quality, or regulated environments.

Responsibilities

• Manage end-to-end quality complaints lifecycle from intake to closure.
• Coordinate investigations with manufacturing sites, CMOs, and cross-functional teams.
• Review investigation reports for technical rationale and alignment with procedures.
• Assess CAPA proposals and ensure actionable follow-up.
• Prepare complaint metrics and management summaries for governance reviews.

Skills

GMP knowledge

Data integrity

CAPA principles

Quality systems

Root cause analysis

Communication skills

MS Office (Excel/PowerPoint)

Education

Pharmacy/Life sciences background

Tools

Veeva Vault QMS

TrackWise

SAP Quality

Power BI

Job description

Job title: Quality Complaint Management Location: Hyderabad 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 You The Quality Specialist – Complaint Management will support the end-to-end execution and oversight of product quality complaint activities, from intake assessment and investigation coordination through documentation review, quality decision support, closure, trending, and continuous improvement. The role is responsible for ensuring complaint records are complete, scientifically sound, data-driven, and compliant with applicable GMP, quality system, and internal procedural requirements. Working in a global and matrix environment, the role will help strengthen complaint governance, investigation quality, stakeholder follow-up, and process performance across Opella’s self-care network. Key Responsibilities Manage assigned product quality complaints through the defined lifecycle, including intake review, classification support, investigation follow-up, documentation review, closure readiness, and timely completion within agreed service levels. Coordinate with manufacturing sites, CMOs, affiliate quality teams, medical safety or pharmacovigilance interfaces, supply chain, regulatory, and other cross-functional partners to ensure appropriate ownership, escalation, and resolution of complaint cases. Review investigation reports for completeness, technical rationale, root cause adequacy, batch or product impact assessment, evidence quality, and alignment with applicable procedures and quality expectations. Support risk-based complaint evaluation by identifying potential quality signals, recurring defects, serious or escalated issues, and cases requiring additional investigation, management attention, or linkage to broader quality events. Assess corrective and preventive action proposals for appropriateness, effectiveness, and traceability, and follow up with responsible teams to ensure actions are clearly documented and progressed as required. Maintain high standards of data integrity in complaint records, including clear narratives, complete attachments, documented rationale, and audit-ready case files. Monitor complaint timelines, overdue actions, investigation extensions, and recurring follow-up needs, and proactively escalate risks to support timely and compliant case closure. Prepare and analyze complaint metrics, trend reports, dashboards, and management summaries to identify patterns, emerging risks, process bottlenecks, and opportunities for improvement. Contribute to periodic quality reviews, governance forums, and business reviews by providing complaint data, insights, action tracking, and status updates as required. Support audits, inspections, and internal quality assessments by preparing complaint records, responding to information requests, and helping demonstrate process control and traceability. Identify, document, and help implement process improvements that simplify complaint handling, reduce rework, improve stakeholder experience, and strengthen compliance outcomes. Support harmonization of complaint management practices across affiliates and global teams by contributing to guidance documents, training materials, templates, and ways-of-working improvements. Act as a quality-minded partner to stakeholders by providing clear communication, timely follow-up, practical recommendations, and a continuous improvement mindset in day-to-day complaint management activities. Qualifications & ExperienceRequired Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, Microbiology, Biotechnology, or a related scientific discipline. Minimum 5 years of experience in Quality Assurance, Quality Systems, Complaint Management, Manufacturing Quality, or a regulated pharmaceutical, consumer healthcare, medical device, or life sciences environment. Good understanding of GMP, pharmaceutical quality systems, complaint handling, deviation or nonconformance management, CAPA principles, documentation practices, and data integrity expectations. Ability to review technical investigation content, challenge conclusions constructively, identify gaps, and translate findings into clear quality decisions or follow-up actions. Strong analytical skills with the ability to interpret quality data, complaint trends, timelines, and recurring issues to support risk-based prioritization and continuous improvement. Excellent written and verbal communication skills, with the ability to prepare clear summaries, follow-up communications, quality rationales, and stakeholder updates. Demonstrated ability to manage multiple priorities, meet deadlines, escalate risks appropriately, and work effectively across cultures, functions, and time zones. Proficiency in Microsoft Office tools, especially Excel and PowerPoint, with the ability to prepare metrics, trackers, dashboards, and management-ready summaries. Preferred Experience using electronic Quality Management Systems such as Veeva Vault QMS, TrackWise, SAP Quality, or comparable complaint and quality platforms. Exposure to global complaint handling processes, outsourced manufacturing or CMO environments, affiliate quality operations, or consumer healthcare quality systems. Experience supporting audits, inspections, quality governance meetings, periodic product reviews, or management review reporting. Working knowledge of complaint interfaces with pharmacovigilance, medical safety, regulatory reporting, product recall, deviations, CAPA, change control, or product quality review processes. Experience with Power BI, advanced Excel, process mapping, automation, or digital quality transformation initiatives would be an advantage. 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