Our client is an ambitious player within the biotechnology industry and has been revolutionary in their approach of combatting life interrupting illnesses since 1980. Their sole purpose is to push the boundaries of modern science, to transform medicine and doing so with a singular focus on improving treatment results. They are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of!
For our client, we are looking for a dedicated Quality Assurance Specialist to join the team in Breda.
* Understanding and application of principles, concepts, theories and standards of technical/scientific field
* Specialized knowledge within own specialty area
* Deepens technical knowledge through exposure and continuous learning
* Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
* Applies research, information gathering, analytical and interpretation skills
to problems of diverse scope
* Ensures compliance within regulatory environment
* Develops solutions to technical problems of moderate complexity
* Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues
* Interprets generally defined practices and methods
* Works under general direction
* Work is guided by objectives of the department or assignment
* Refers to technical standards, principles, theories and precedents as needed
* May set project timeframes and priorities based on project objectives and ongoing assignments
* Recognizes and escalates problems
* Contributes to work group/team by ensuring the quality of the tasks/services provided by self
* Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup
* Provides training/guidance to others and acts as a technical/scientific resource within work group/team
* Establishes working relationships with others outside area of expertise
* Complaints handling (including performing assessments) at our client's Breda location in accordance with internal procedures, regulatory guidelines and business performance objectives.
Position Specific Tasks
* Initiate and own product quality complaints, Safety quality investigations and product security investigations for Amgen commercial and/or clinical products
* Perform assessments in support of complaint investigations (e.g. batch record review, reserve sample inspection, Return sample inspection and Safety Features verification)
* Partner with corporate product quality surveillance, assessors from other Amgen sites and contracted partners to resolve product complaint investigations
* Partner with Amgen affiliates in country and intake call centers on call intake procedures and complaint investigations
* Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements
* Assist in Amgen Breda projects and improvement efforts as needed
* Provide training to ABR and Amgen affiliate staff on complaint handling procedures and performing investigations/assessments
* Initiate and own QA Non Conformances/CAPAs as needed
* Participate in site regulatory inspections of complaint handling process and in audits (internal and third party) as required.
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.
MBO or Bachelor's degree or equivalent
Typically 3 or more years of related professional experience
Fluent in English language.
Master's degree or equivalent
Minimal related professional experience
Fluent in English language.
Experience in Quality Assurance, including handling product complaints investigations; Experience in pharmaceutical industry
What we offer
* Initial contract via Kelly Services for 12 months
* Max salary of 4500 EUR per month, depending on experience
* Start date: September 2022
* A great opportunity to join an internationally recognized and inspirational organization in Life Sciences where your contribution will be highly valued and where you will get the chance to be part of challenging projects that change people's lives.
Contact us today!
T: 06- 12963210
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Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.