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Job purpose:
- Responsible for Quality Management System implementation and monitoring of compliance within the Consumer Healthcare of GSK
- This position reports to Quality Assurance Operations Manager
Key responsibilities:
- Manage product incidents and support and coordinate product recalls according with the Romanian legislation and internal Standard Operation Procedure.
- Report and follow-up on product complaints with manufacturing sites, patients, customers and Commercial teams according with the Romanian legislation and internal Standard Operation Procedure.
- Conduct audits of local Logistics Services Provider, Distribution warehouses and printers and ensures that the contractors comply with GSK and regulatory requirements.
- Collaborate with Regulatory, Sales and Logistics departments to identify issues that could affect product quality.
Coordinate all matters pertaining to regulatory and QA compliance for repacking procedures to ensure timely QA batch release of repacked orders before distribution and/or re-export.
- Back-up Qualified Person.
Ideal Candidate:
- Mandatory degree in: Pharmacy / Medicine/ Chemist/ Biochemist; Qualified Person Certificate.
- Relevant experience of minimum 2 years in a similar position.
- English – advanced level.
- Intermediate skills in Microsoft Word, Excel, Power Point and Outlook.
- Professional written and verbal communication skills.
- Well organised person.
- Analytical mind, good attention to detail and problem solving skills within a structured process.
- Good team player – works well in cross-functional teams.
- Ability to multi-task and work under pressure.
- Works with a spirit of continuous improvement and innovation, creatively open to new ideas and ways of working.
- Flexible thinking – able to challenge and see views from different perspectives.
- Ability to self-motivate and be resilient and focused under pressure.
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development and Teamwork.
As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigor and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being.
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness.