Our client's mission is clear: they seek to provide quality affordable healthcare products. With over $5.5 billion in sales and more than 10,000 people working around the world, our client is a leading global Self-care supplier.
To support compliance activities on site, we are looking for a Qualified Person, who will work within the QP team to support batch disposition activities and to support quality systems to ensure the site remains compliant with current GMP requirements. Supplier management and the oversight of the internal audit program are key components to your role. You will also take the lead in various product categories, supporting technical transfer activities and providing general compliance support to the site.
Interested? Apply by sending your resume to email@example.com or call 03 200 28 01 for more information.
Qualified Person and looking for a new challenge? Take a look here!
- Perform duties of a Qualified Person as defined by Directive 2001/83/EC of the European Parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use.
- Assume ownership for and drive the Perrigo batch disposition process, including review of third-party batch paperwork.
- Provide QP input to key quality systems: change control, customer complaints, PQRs, product investigations, RA strategies, supplier management and technical transfers (this list is not exhaustive).
- Participate in project category meetings and be a senior compliance leader and advisor to the site, ensuring compliance requirements and implications are always core to the decisions taken by the business.
- Work cross functionally to ensure that the site retains its license to operate and that compliance continues to be held as a core focus area across the site.
- Assist in supporting operational compliance by applying quality risk management tools and principles in assessments and investigations, in order to support compliance decisions. This support is provided both formally in investigation meetings/ document reviews and also on an ad hoc basis via on the floor conversations with stakeholders at all levels of the business.
- Responsible for maintaining an effective recall process on site.
- Responsible for championing compliance standards on site, working with stakeholders to ensure that quality standards are maintained and opportunities for improvement, once identified, are actioned.
- Manage department-level projects/ initiatives, as assigned, e.g. continuous-improvement projects based on the quality system.
- Conduct both internal and external audits as required.
- Provide guidance and mentorship to other QA department members and to work closely with the other QP’s to ensure that the QP group are an authoritative and supportive expert group.
- Hosting customer audits and assist in the preparation and participation in inspections.
- In addition to the duties and responsibilities listed, the jobholder is required to perform other duties assigned by your Manager or other senior site personnel from time to time.
What do you need to be successful?
- Master's degree in industrial pharmacy
- You preferably have previous experience in internal and external auditing, and operational support in a QA role. Experience in the application of Quality Risk Management tools is a requirement. Experience in management of department-level projects would be advantageous.
- You have a keen interest in current trends within the industry and how these trends can be actively adapted into site improvements.
- You are an energetic and self-driven professional who is willing to both lead and participate in group activities in order to achieve company successes.
Wat bieden wij?
As an answer to your high performance & flexibility, Ausy offers you an interesting salary package, with some interesting extra's like:
- Meal vouchers of €7
- Net representation cost of €50
- Hospitalisation insurance
- Car + unlimited fuel card OR home-work compensation
- 32 holidays
- End-of-year bonus
- Pension plan
- ECO vouchers
- Opportunities to follow training's
And on top of this you'll improve your research techniques and become an even bigger R&D expert!
Anaïs BosmansAnais_Bosmans@cx.ausy.be 03 369 19 80
03 369 19 80
Organisatie Randstad Medical
Job Qualified Person
Naam Randstad Medical
Adres Access Building, Keizer Karellaan 586, bus 8