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Om First Reserve:
Vi är ett rekryterings- och bemanningsföretag som levererar tjänster inom HR, ekonomi, lön, inköp/logistik och administration. Inom lön har vi även ett eget outsourcingbolag.
Med laganda, utveckling, ansvar och engagemang som ledord vill vi alltid vara den självklara samarbetspartnern för både medarbetare och kunder. First Reserve är ett företag med stabil tillväxt och ett starkt varumärke med ständigt affärsfokus. Vi har kollektivavtal och är ett auktoriserat bemanningsföretag.
Vårt kontor är placerat i Solna Business Park.
When our customer see an opportunity for change, they seize it and make it happen, because an opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential.
The Global Supplier Quality (GSQ) organisation leads Supplier Quality oversight for externally sourced materials to ensure that they align with theirs quality Standard, are safe and effective and meet the required regulatory standards.
They do this through execution of the key Pharmaceutical Quality System (PQS) and supplier management business processes, by experienced and qualified Quality Professionals.
This is a diverse and interesting role working with Suppliers, Contractors and a broad range on the Company sites and functions. You will collaborate with colleagues and customers across many countries and interact cross-functionally with supply chain, supplier relationship, technical and project roles. Some travel may be required along with a high level of independence for the role.
GSQ provides Quality oversight globally for approximately 1,600 supplier sites.
The scope of the organization includes outsourced API, Biologics CMOs, Direct Materials including Devices, Formulation and Packing CMOs, Critical General Services, Contract Laboratories, Certification of Materials and the global IT System for Supplier Management.
In this role, you will be responsible for assuring the quality of materials received by the company from the designated supplier portfolio and will proactively ensure GMP and regulatory compliance during supplier related projects. You will be responsible for the Quality System oversight of Supplier related product quality complaints, change controls, deviation investigations, issue management and escalation, and Quality Agreements between the company and External Suppliers; and the preparation and submission of Supplier Quality Risk Assessments, and support to Regulatory Agency inspections of supplier sites and site transfers. You will drive quality improvements at the supplier as part of a cross functional team
This role will also include the quality review and approval of Chemistry and Manufacturing Control (CMC) documents associated with changes or product establishment at suppliers.
Key to this role will be maintaining a high level of understanding of relevant production processes and quality systems.
• Degree in a science / technical field such as Pharmacy, Biology, Chemistry, Engineering or equivalent experience
• Broad experience with a minimum of 5 years relevant work experience in either the pharmaceutical operations environment or a pharmaceutical Quality Assurance role
• Excellent oral and written communication skills
• Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also, strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
• Demonstrated experience working cross-functionally and leading significant improvement initiatives (e.g. project management skills)
• Strong problem-solving skills
• Strong negotiating/influencing skills
• Ability to work independently under your own initiative.
• Ability to travel nationally and internationally as required up to approximately 10% of their time.
• Experience working in a PCO/PET organization or Lean/Six Sigma training.
• Multi-site / multi-functional experience - particularly within a manufacturing site environment.
• Proven experience in Quality Assurance or combination of Quality and Technical.
Why you want to start as a consultant at First:
As consultant at First, we as an authorized staffing company with a collective agreement. We offer you a market salary, health care allowance, pension provision according to ITP and insurance. You as a consultant are also assigned a dedicated consultant manager who is there to support you in your career. With the words Commitment, Development, Team Development and Responsibility, we are welcoming you to a company where you as a consultant are the focus!
A crucial success factor for any company is to make use of people's differences and you can easily search by registering your CV by clicking on the application button below or with your Linkedin profile. As the selection and interviews are ongoing, we wish your application as soon as possible.
If you have any questions about the service or process, you are most welcome to Contact [email protected]. With reference to GDPR, we have no opportunity to receive any applications by mail.