Quality Expert Europe (m/f) - Global Pharmaceutical Company
This person will be responsible for quality management and compliance of the medicinal products and processes including packaging activities.
Client Details
Our Client is a global player on the pharmaceutical market, specializing in the production of active pharmaceutical ingredients and biosimilar products. With strong presence in APAC and United States, the company is successfully expanding its operations in Europe. Due to further dynamic growth, we are looking for an experienced Quality Expert for Europe.
Description
- Coordinate or participate in external inspections of external authorities and third parties and follow-up on responses and corrective actions
- Perform audits in European subsidiaries and local agents/distributors to ensure compliance with relevant policies and practices
- Investigate and coordinate complaint, return, recall events in Europe and manage them in collaboration with marketing, clients, importer and Qualified Person
- Assist MAH in the selection and audit of contract manufacturers in Europe
- Ensure that secondary packaging sites, re-packing/co-packing are in line with regulatory requirements
- Coordinate quality activities such as GMP and GDP with European importers
- Monitor quality updates in the European regulations, evaluate the impact and notify Global Quality Center where necessary
- Conduct regular trainings on European: drug administration, GMP and GDP guidelines and support the Global Quality Center with relevant input
- Coordinate quality affairs in Europe and report progress on the European quality business to Global Quality Center
- Oversee and establish GMP and GDP systems in European subsidiaries
Profile
- At least five-year experience in quality in pharmaceutical industry including international exposure (quality audits will be an asset)
- Experience in complex, matrix environment and cross-functional/cross-country collaboration in strongly multinational set-up
- Fluent English is a must
- Self-starter with strong entrepreneurial spirit able to work under little supervision
- Experience in pan-European distribution systems will be an advantage
- Practical knowledge of EU drug administration, EU GMP/GDP guidelines including licensing of medicines, current directives and regulations related to wholesale distribution of medicinal products
- Product quality and compliance management under tight deadlines
- Excellent organization, communication and execution aptitudes
- Strong sense of confidentiality
Job Offer
- Independent position with significant exposure in the global structure
- Possibility to progress the career vertically and horizontally
- Working in diverse business cultures
Please apply via the button on the right side of this job offer.
Job details
Location: Warsaw
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
More
Location: Warsaw
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
More
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