Job title
:
Quality Specialist Complaint Management
About The Job
Our Business and Team:
At Opella Healthcare we aim to become the best FMCH Company IN and FOR the World. We are a standalone and more agile organization.In Global Quality we are focused on the achievement of the Excellence that is under leadership of the diverse team.The position holder acts as Quality responsible person and on the first level of escalation to resolve Quality complaints promptly and to minimize the overall risk to the company.The position holder ensures actively the Complaints management of the portfolio produced by Contract Manufacturing Organizations in line with current GMP and company requirements.Important internal and external relations: CHC External Manufacturing Quality Assurance, CHC External Manufacturing Quality System, Global Quality External Manufacturing, Global Manufacturing & Supply, Supply Chain Managers, Quality System Excellence, Contract Manufacturing Organizations, Distributions Centers.
Main Responsibilities
Complaint management of portfolio from Contract Manufacturing Organizations in line with current GMPs, and company requirements
- Supporting the team Lead complaint management and Quality Assurance responsible to ensure timely handling of product complaints.
- Take care of the complaint management inbox
- Ensure overview of incoming complaints and monitoring of due date at the CMO and Global complaint management level.
- Assignment of incoming Complaints to the respective CMO
- Assessment ad categorization of the complaint
- Recurrence monitoring
- Corrective & preventive actions follow up
- Documentation of investigation in the system
- Closure of the complaint in the system
- Potential exchange with the affiliate
- Contribute to the monitoring / trending of complaints.
- Monthly KPI evaluation and reporting
- Preparation of summary for Product Quality Reviews
- Contribute in the annual CMO Risk ranking exercise
- Deliver accurate global quality metrics for Product Quality Complaints and support leadership meetings.
Experience
About you:
- 6-10 years in pharmaceutical environment, preferably in Quality, i.e. complaints management,
quality control/assurance, systems quality assurance and/or quality systems management
- experience in external quality management activities
- experience in management of CMOs, subcontractors / suppliers
Soft Skills
- Ability to work in the diverse team (several locations)
- Communication skills
- Problem solving
- Being proactive
- Team work
- Strive for results
- Committed to customers
Technical Skills
- Commit to customers
- Cooperate transversally
- Analytical and structured way of thinking, high sense of responsibility
Education
- Qualification in Pharmacy or Natural Sciences
- Good oral and written communication skills
- Sound knowledge of pharmaceutical regulations/GMP
Languages
: Good English language skills to effectively negotiate and communicate verbally and in writing.
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
