Quality Assurance & Regulatory Affairs Specialist
Quality Assurance & Regulatory Affairs - Braine-l'Alleud
PolyPeptide Laboratories is a high-tech enterprise specializing in the development, manufacture and sale of therapeutically active peptides. PolyPeptide SA, with approximately 250 employees is part of the international PolyPeptide Group with companies in Sweden, India, USA, France and Belgium.
For our Belgian subsidiary based at Braine-l'Alleud, we are looking for a Quality Assurance & Regulatory Affairs Specialist whose main duties will be to:
REGULATORY AFFAIR :
- Work within the Quality and Regulatory team to maintain focused, effective progression in line with Polypeptide objectives
- Inform management in case of any major quality or regulatory issue
- Compile registration applications. The regulatory departement is working closely with the involved departments within PolyPeptide and with the customer.
- Regulatory ensures the high quality of the regulatory submission documentation and that it contains the appropriate information required by the authorities.
- Ensure timely submissions to Health Authorities
- Ensure that registration applications are approved by the relevant authorities.
- Maintain registrations in compliance with the procedures in place and with the current regulatory regulations.
- Provide regulatory guidance as needed
- Have knowledge in applicable regulatory guidelines
- Assist Sales & Marketing in promoting PolyPeptide and in giving potential and current customers the highest possible quality service.
- Be the direct contact with customer’s and regulatory authorities regarding clinical trial and marketing applications/authorizations.
- Work with global RA projects and with support to RA at other PolyPeptide sites as assigned.
QUALITY ASSURANCE :
- Manage and approve change controls, CAPAs & deviations
- Review and approve the documentation linked to quality agreements, process optimization & validation, analytical & QC activities, manufacturing operations and annual product review
- Develop, implement and manage documents related to Quality Operations activities in order to comply with the cGMP or other legislation, with PolyPeptide Quality System and customer requirements
- Check compliance with quality systems, regulations and customer requirements
- Assure the release of API batches
- Manage customers' audits, requests, complaints and recalls
- Perform internal audits as required
- Monitor Quality indicators and help to gather and track relevant data.
- Work with counterparts from other PPL sites to establish common best practices in quality related systems, policies and procedures
What we expect from you is:
Industrial Pharmacist or Master in Sciences with
minimum 5 year experience in QA and/or RA fields in the API manufacturing sector
- Fluency in French and English is mandatory (spoken and written English)
- Excellent command of Word, Excel and PowerPoint
- High organizational skills, good interpersonal skills, flexibility in tasks and schedules
- Sense of responsibility, enthusiasm, diplomacy and team spirit
PolyPeptide offers an informal, dynamic and exciting work environment with a good opportunity to work with a broad variety of tasks within the dedicated department. You will be working closely with the other departments of PolyPeptide.
In the PolyPeptide Group, we strive to work together as one team.
What we offer is a full time contract with an attractive salary and extra-legal benefits and insurances; a challenging position in an innovative and dynamic work environment with an open culture.