Global Quality Assurance Senior Associate / Associate Medical Devices
Perrigo is one of the largest and most dynamic companies in the consumer health and personal care industry. Perrigo has a very wide brand portfolio including top brands like Zantac, Prevalin, Beconase, Solpadeine, Optalidon, Lactacyd, Davitamon, Galenco, Bodysol, ACO, Phytosun, XL-S and Paranix. The portfolio includes human and veterinary medicines, medical devices, cosmetics, food supplements and biocides.
Perrigo is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.
Some of Perrigo’s products are manufactured internally (8 plants spread over Europe) while the remainder is outsourced to specialized third-party contract manufacturers, mainly based in Europe.
In order to support the Global Quality Assurance Operations team in maintaining a high-performance QA structure for the Perrigo Group, we are currently looking for a
MAIN OBJECTIVES OF THE JOB
- To ensure compliance with ISO13485, ISO14971 and other harmonized standards.
- To ensure compliance with EU Medical Device Directive/EU Medical Device Regulation & other regulatory requirements.
- To act as quality assurance lead supporting business needs in the medical device area including new product developments, roll-outs and maintenance projects.
MAIN DUTIES AND RESPONSIBILITIES
- You will act according to the Quality Assurance (QA) vision, strategy and standards for the integrated Corporate & Country QA group.
- You will be the QA representative within certain product categories and be responsible for all QA matters associated with these.
- You will agree Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors).
- You will help with due diligence and integration of new product developments / new product introductions for assigned categories.
- You will support technical transfers, qualification and validation work.
- You will investigate quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with third-party contract manufacturers.
- You will evaluate and follow-up Change Controls together with the Regulatory Affairs team.
- You will agree stability programs and review stability results.
- You will be part of Supplier Qualification and Regular Supplier Auditing.
- You will occasionally provide QA training to the entire group regarding QA systems and processes and procedures and evaluate training effectiveness.
- You will maintain databases and documents according to good documentation practices and record retention procedure.
- You will support in the maintenance of the Quality Management System as SME.
- You will support the internal QA audits.
- You will identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives.
- You will support QA in data and document collection for regulatory purposes.
- You will support QA in ensuring ongoing inspection readiness in your area of responsibilities.
- Clear communicator, practical and solution orientated.
- Enthusiastic and get the job done.
- Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem solving skills.
- Regular international travelling is inherent in this role.
- Ability to work on several projects in parallel in a flexible manner both autonomously and in a multicultural team environment.
Qualifications and work experience:
- A Masters’ Degree in pharmaceutical or biomedical sciences, engineering, biochemistry, chemistry, or other related subjects, or equivalent through experience.
- At least 3 years relevant experience in Quality Assurance / Production.
- Knowledge of EU Medical Device Directive/EU Medical Device Regulation & other regulatory requirements for medical devices.
- Knowledge of and experience in ISO13485, ISO14971 and other harmonized standards.
- Knowledge of manufacturing processes of solid, semi-solid and liquid formulations.
- You speak and write fluently English. Other languages are an asset.