QA Development Manager

il y a 1 jour

Brussels, Belgique CordenPharma Brussels Temps plein

Brussels, BE

**Our Company**
CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2’600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.
Our network in Europe and the US offers flexible and specialized solutions across five technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
**Role**
As **QA Development Manager** you will be working as part of the CordenPharma Brussels Quality Assurance Department to ensure the successful transfer and manufacturing of products from CordenPharma affiliates and/or customers in accordance with cGMP rules, within boundaries of quality, time and budget.
Under the direction of the QA Director, you will act as a QA representative and a member of a multidisciplinary team working together on innovative projects at different clinical development stages. Based on significant quality and compliance expertise, you will review and approve project deliverables and provide direction to team members. Recognized as expert by peers and other personnel within the business.
- Provide expertise on the creation of Product development and manufacturing deliverables to multifunctional teams.
- Assisting in further develop and maintain Quality System to ensure compliance with the requirements of the customers, of the authorities and the Corporation (e.g. audits).
- Provide guidance and expertise on the main Quality Processes (Change Control, Deviation, CAPA).
- Support the organization for the site inspections.

The ultimate goal is to ensure that Quality and Compliance aspects are respected to maintain the required Compliance level and assure successful outcomes of Customer audits and Health Authority inspections.
**Duties and responsibilities**
- Act as the Compliance referent and Quality representative during the project meetings and with customers.
- Support and participate actively in development of documentary package related to the project lifecycle from process development and scale up to validation and commercial production (risk analysis, process scale up and transfer, VMP, PQR ).
- Carry out the project related reporting and the necessary escalation to the relevant management.
- Review and approval of development and transfer related protocol and reports.
- Review and approval of manufacturing related master documents (Batch Master Files, SOPs ).
- Review and approval of validation related protocols and reports.
- Approval and follow up of planned production campaign records and activities.
- Follow up of QA Project deliverables (e.g.: Deviation CC, CAPA, customer requests)
- Change Controls and CAPA plans approval and follow up.
- Self-inspection activities, internal audits and shop floor Quality oversight.
- Contribution to the preparation and success of external audits and inspections.

**Qualifications and skills**
- Master in Sciences or equivalent by experience
- Min.5 years in a QA in a GMP environment
- Experience in CDMO is an asset.
- Ability to work independently in a fast paced multitasking environment.
- Rigorous with excellent organization and coordination skills.
- Strong customer oriented-mindset.
- Flexible, able to set priorities and solution oriented.
- Team spirit and ability to work in an interdisciplinary and international environment.
- Strong oral & written communication skills (English & French).

**What we offer**
We offer a permanent contract, a competitive salary package and varied and motivating responsibilities.
**Interested?

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