Quality and Regulatory Affairs Officer Benelux
Working for a renowned company
A flexible role with broad responsibilities
Over onze klant
Within Nestlé Skin Health, Galderma provides prescription drugs, OTC drugs, cosmetics and aesthetics solutions going beyond treating skin problems to also protect and enhance healthy skin, treat compromised skin and rejuvenate aging skin.
Taken en verantwoordelijkheden
As Quality and Regulatory Affairs Officer Benelux, you are responsible for all activities related to Quality Assurance. You maintain the local Quality Management System (QMS) and monitor its compliance status. Galderma offers a versatile product range for all ages consisting of, amongst others, prescription drugs, OTC drugs, medical devices, cosmetics and food supplements with their own Quality requirements. Therefore, as part of a multidisciplinary team, you need to be able to switch between different product groups in an efficient and successful manner. As you are expected to support other activities within the Regulatory and Medical Affairs Benelux department, your responsibilities are broad. In addition to Quality Assurance, they include tasks related to Regulatory and Medical Affairs and, occasionally, you will provide support to Vigilance, Price & Reimbursement, and Compliance.
Typical duties and responsibilities
- Responsible for ensuring Good Distribution Practice (GDP) is complied with for products imported and wholesaled by Affiliate;
- Product complaints management;
- Temperature deviations management;
- Administrative release management;
- Perform Quality and compliance specific tasks including but not limited to processing; product complaints, review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination;
- Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs;
- Implementing and maintaining the QMS to ensure that required processes are established and effective;
- Process owner of quality systems such as, but not limited to; internal audits / self- inspection, change control, management reviews, deviation management and CAPA;
- Compile and update training manuals, undertake induction training and refresher training related to QMS for local affiliate staff;
- Ensure quality agreements are established with affiliate 3rd parties;
- Ensure affiliate 3rd parties are qualified and maintained in an approved audit status;
- Ensure product samples are authorized with maintained traceability and product integrity;
- Decision of disposition for trade returns and damaged products;
- Authorization of any product from quarantine to approved product status;
- Maintenance, analysis and reporting of Quality KPIs;
- Ensure local repackaging of products is performed in accordance with specifications and required licenses;
- Review all packaging artworks from a local regulatory perspective as per internal and Corporate and local SOPs in place;
- Responsible for customer approvals: ensure that only the right customer is obtaining the right product;
Regulatory and Medical Affairs
- Submission and implementation of variations for products in the Benelux;
- Publicity check: Review of promotional activities (materials and promotional literature);
- Back-up for handling adverse events;
- Report adverse events according to procedure.
Given the broad set of tasks of the Quality and Regulatory Affairs Officer Benelux, a critical mindset is of utmost importance. You have a strong personality and know how to perform under pressure. While prioritizing urgent matters, you have the ability to switch between different responsibilities. You contribute proactively and autonomously while working within the framework of internal and external regulatory guidelines and procedures. You are expected to take initiative, bring in new ideas and directly engage with customers. Consequently, excellent communicative and interpersonal skills are essential. An eye for detail without losing sight of the big picture is required to successfully fulfill this position.
- Master's Degree in Pharmacy, Life Sciences, Medicines or equivalent;
- Minimum of 5 years' experience in the (bio-)pharma industry, preferably in Quality Assurance (and Regulatory Affairs);
- While the focus is on Quality, knowledge of Regulatory Affairs is a plus;
- Knowledge of Electronical Document Management Systems is an advantage;
- Fluent Dutch (speaking & writing), Fluent English (writing & speaking), French is a plus;
- Advanced Microsoft Office (Word, Excel, PP & Outlook) & SharePoint skills;
- Flexible, responsible, independent, organization skills, accurate, takes initiative, focus on customers and brand awareness.
- Competitive salary;p
- 13th month;
- Travel allowance;
- 25 vacation days + 6 company days.