Supplier Quality Lead and Engineer

Supplier Quality Lead and Engineer for supporting a transfer project

Hays Specialist Recruitment is now looking to recruit a Supplier Quality Lead and Engineer for supporting a transfer project for an 11 month contract assignment for a leading pharmaceutical client in Helsingborg.

To support in transfer projects, we are searching for a person with experience in starting up new suppliers in a controlled environment (pharma, food, medical device or similar). The assignment requires you to work both strategic and operational.

Key Responsibilities:

* Be the one representing the Quality organization in the project team
* Manage new supplier qualification and change control
* Assuring quality end-to-end for components/items in scope
* Manage supplier quality issues (i.e. micro failures, rejects, etc.) and follow-up on-site investigations for the project
* Audit and perform supplier assessment
* Identify and make updates of internal quality documentation
* Assist in the measurement and release of components Qualifications
* Scientific degree (Pharmacy, Chemistry, Engineering or related field)
* Good knowledge in molded plastic components(production, quality and/or procurement perspective)
* Working knowledge of the pharmaceutical drug product (or equivalent) operating functions of quality and compliance, material supply, material handling and control, product manufacturing and product packaging gained through:
* Responsibility and experience in a GMP product manufacturing plant environment
* Auditing experience is preferred
* 5 to 10 years of pharmaceutical drug product industry (or related industry) experience
* Fluent English (spoken and written)
* Understanding and application of current Good Manufacturing Practices and Agency compliance expectations
* Experience of working in and preferably leading projects.
* Personal skills will be decisive: personal organization, autonomy, leadership, relational and communication skills, convictions, critical thinking, adaptability in a changing and complex environment, attention to details and overall view)