QA Specialist - QA System

You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As a QA Specialist, you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human. 

About the job:  

Perform and monitor tasks related to the system aspect of QA department; support other tasks of QA department to ensure all processes and products reach GMP and Opella group requirements, which are defined in global documents and guidelines.

 Main responsibilities:  

1. Quality System Management

• Supervise GxP training activities, including setting up GxP and Halal training programs and monitoring training effectiveness.
• Act as a GMP trainer for plant employees.
• Ensure compliance with GMP requirements in relevant departments such as the warehouse.
• Monitor and implement corrective and preventive actions (CAPA) related to quality events.

2. Self-Inspection & Audits

• Develop and execute self-inspection plans in accordance with company procedures.
• Participate in regulatory inspection handling: Global Quality Audit, GMP inspection by DAV, TGA, GMP for cosmetics by DAV, Halal by LPOM MUI, HS…
• Track and follow up on corrective and preventive actions (CAPA).

3. Quality Performance Monitoring

• Implement QMI (Quality Management Indicators) and QCMA (Quality Control Maturity Assessment) programs as per the defined frequency.
• Monitor, summarize, and report results to managers.

4. Directive Implementation & Compliance

• Update, monitor, and apply quality directives and guidelines from the corporation and regulatory authorities.
• Ensure compliance between internal procedures and global quality documents.

5. GxP Documentation Management

• Supervise the GxP documentation system, including SOPs, specifications, batch records, procedures, and records.
• Issue, supersede, and archive documents following SOPs.

6. GMP and halal training

• Supervise GxP training activities, including setting up GxP and Halal training programs and monitoring training effectiveness.

7. Others

• Take the Local Admin role for CMS system and back up Local Admin for Event, CAPA, ILI (Investigation & Learning from Incidents), and Change Control (CC) systems.
• Support the implementation of quality improvement initiatives within the site.
• Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
• Support other activities when needed.
• Compliance with HSE requirements.

About you:  

• Graduated university and have knowledge of operations and pharmaceutical production.
• Has experienced and used to work in quality assurance system or GMP site.
• Perform capacity to understand key business issues which impact on quality operations and the impact of quality on the commercial operations.
• Good knowledge of GMP, HSE system.
• Well organized, planning and time management
• Good two-way communication, good adaptability to multi-culture environment.
• Fluent in English-4 skills
• Advanced in using Word, Excel, power point.

This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella. 

About Us: 

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.  

As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.