For one of our clients located in Brussels, we are looking for a "Senior Qualified Person".
Our client is a research-based, global biopharmaceutical company. They apply science and global resources to bring therapies to people that extend and significantly improve their lives through the discovery, development and manufacture of healthcare products.The main responsibility will be to work with the Service Company team and key stakeholders including Customer Service Operations, IICC (Inbound, Inventory, Compliance, Controlled Substances), Customs and ICMD (Intercompany Master Data) to ensure that all products physically and/or financially owned are released for sale to global markets in accordance with the EU GDPs.
The scope of work has accountability for the implementation, execution, monitoring and compliance of the Quality Systems in support of the release for sale activities.
- Review, evaluate and support complex investigations and present formal notifications of significant issues to senior management and Quality Review Teams
- Ensure fulfillment of local legal regulations
- Ensure that the provisions of the license are observed
- Ensure that the operations do not compromise the quality of medicines
- Ensure monthly metrics are gathered and communicated in a timely way
- Act as RP for Upjohn for the GDP licenses responsible for as notified to the respective BoH. The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices. The duties of a RP include:
- Ensuring that a quality management system is implemented and maintained
- Focusing on the management of authorized activities and the accuracy and quality of records
- Ensuring that initial and continuous training programs are implemented and maintained
- Coordinating and promptly performing any recall operations for medicinal products
- Ensuring that relevant customer complaints are dealt with effectively if applicable
- Ensuring that suppliers and customers are approved
- Approving any subcontracted activities which may impact on GDP
- Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
- Keeping appropriate records of any delegated duties
- Deciding on the final disposition of returned, rejected, recalled or falsified products
- Approving any returns to saleable stock
- Ensuring that an additional requirements imposed on certain products by national law are adhered to
Do the above responsibilities fit you like a glove?
Download your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.
- A minimum of a bachelor's degree in sciences or Engineering
- A RP/QP qualification recognized by Belgian Health Authorities
- A minimum of 10 years previous experience is required within the pharmaceutical industry - preferably within the Quality and/or Compliance fields.
- In depth knowledge of GDP and legal requirements.
- Able to work well in a matrix organization set up and influence key stakeholders.
- Good interaction and clear communication skills with multiple stakeholders is required.
- Worked extensively with contractors and service providers is an asset.
- Able to influence indirect reports to deliver results.
- Fluent in English (spoken and written), ability to speak and read Dutch or French will be an added advantage.
- Experience in Quality administered systems.
- Excellent system skills - Word and Excel essential, experience with electronic documentation control systems advantageous
- Previous use of Trackwise® and SAP beneficial.
- Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy and documentation.
- Knowledge of drug regulations and regulatory guidance of FAMHP and other leading agencies (EMA, FDA) is a strong asset.
- Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
- Insight and understanding of shareholders needs and requirements.
- Dynamic, flexible, enthusiastic and eager to learn.
- Takes initiative and ownership to deliver on time without compromising on quality.
- Ability to work under minimal supervision and in a team.
- Able to demonstrate good planning and organization skills.Ability to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.
- High level of self- integrity and ethical conduct
- Excellent Quality Decision making skills.
- A balanced salary package based on your capabilities and experience, including meal vouchers, assurances, ...
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy Number: 16233