Quality Analyst Specialist - Serialization

Job title: Quality Analyst/Specialist- Serialization

• 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: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide.

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 four 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 to bring health in your hands at www.opella.com.

About The Job

Key Responsibilities:

Validation activities

• Contribute to Business Requirements preparation and approval
• Review and approve validation protocols and reports
• Ensure conformity of validation documentation with evolution of applicable cGMP and
  
  

applicable regulatory requirements

• Perform impact analysis and risk assessment link to Trace link validation
• Support execution of serialization implementation at CMOs, including change management,
  
  

testing, training, user access, lesson learned

• Ensure process improvements and changes are evaluated and implemented through the
  
  

change control management process

• Maintain the traceability matrix
  
  

Quality system

• Ensure documented processes and procedures are in place for all activities to meet quality and
  
  

compliance requirements

• Ensure continuous update of Trace link validation documentation and SOPs
• Deliver training to the involved stakeholders of processes and procedures
  
  

Routine activity, events and CAPA

• Manage the Quality events (deviations, complaints, risks) and association CAPA related to the Trace link serialization with CMOs in compliance with the External Manufacturing Europe
  
  

procedures

• Management of incidents with the CMOs and Trace link incident management
• Perform monitoring of errors and contribute to troubleshooting resolution
• Monitor CMO process performance and execute periodic KPI analysis
• Audits
• Contribute to the internal audits
• Support the inspections (intellectual service)
• Manage CAPAs related to the observations from the audits
• Analyse of the impact of observations from the audits on Sanofi quality and
  
  

serialization/aggregation processes

Continuous improvement

• Propose and implement process upgrades and efficiency improvements.
  
  

About You

Education Qualification in B Pharma/M Pharma preferable.

5+ years of experience in Quality, Deviation, Documentation, CAPA, Incident Management. Supply Chain and Serialization.

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 others 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

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