QA Officer

Geplaatst 22 September 2022
Salaris Up to €3500 per month
LocatieBreda
Soort vacature Temporary
BedrijfssectorenLife sciences vacaturesWerken bij Amgen
ReferentieBBBH560769_1663855249

Vacature omschrijving

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 an experienced QA Officer to join the team in Breda. Become the professional you are meant to be in this meaningful role and be sure to apply today!

What we offer
* Initial contract via Kelly Services for 12 months with possibility to extend
* Max salary of 3500 EUR per month, depending on experience
* Start date: November 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. Ultimately, you will receive Full support and resources to expand your skills, enhance your expertise, and maximize your potential along your career journey.

Accountabilities
* Perform QA oversight for validation of equipment, automation and information systems and for Quality Risk Management
* Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met
* Provide guidance and direction to operations staff regarding compliance with quality policies, standards and procedures
* Provide quality engineering support for testing strategies and quality investigations

Responsibilities
* Process, equipment and IS validation
* Agrees on strategy and provides guidance regarding design, characterization and validation in cooperation with PD / M&E / IS, while ensuring GMP quality and compliance.
* Reviews and approves validation documentation
* Maintenance & Engineering support
* Reviews and approves changes to equipment (e.g. parameter changes, like for like assessments)
* Reviews and approves changes to M&E procedures (e.g. change over process, preventive and corrective maintenance)
* Device and combination product
* Manages ABR's device responsibilities and ensures alignment with GMP regulations
* Quality Risk Management (QRM)
* Represents QA in QRM activities (pFMEA, QRAES, Computer system compliance)
* Ensures alignment of site Quality Risk activities with corporate policy and strategy
* Reviews quality risk assessment summary reports
* Change control
* Performs final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record
* Functions as QA SME and collects input from different QA areas to complete the QA assessment for technical changes

Authority
* Works under general direction
* Work is guided by objectives of the department or by project objectives
* Manages multiple assignments and processes
* Recognizes and escalates problems or risks to project quality delivery or timelines

Outputs
* Delivers quality objectives according to project plan
* Delivers validated systems, meeting corporate, site and regulatory requirements

Qualifications
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.

Minimum Requirements
* MBO or Bachelor's degree in Life Sciences or process technology related field or the equivalent combination of education and/or experience
* Typically 3 years of relevant experience in the pharmaceutical or medical device industry with experience in Equipment and Automation Validation
* Good Manufacturing Practice (GMP), equipment and automation/IS validation, computer compliance (Annex 11, Part 11) knowledge with the ability to interpret and apply in mainly routine cases
* Manufacturing and/or Quality analytical processes and operations
* Fluent in the English language.

Preferred Requirements
* Experience with pharmaceutical industry
* Experience with Non conformances, CAPAs and Change Control

Competencies
* Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
* Good understanding of quality engineering tools
* Keeps overview but also deep dives when appropriate
* Effective communication skills at multiple levels and areas (inside and outside of Quality)
* Good attention to detail and excellent writing skills
* Good decision making skills and ability to apply risk based approach
* Teamplayer, constructively working together towards solutions

About Kelly Services
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. Ultimately, at Kelly, we believe that our inclusive approach is of paramount importance to the success of all of our services.

Contact us today!
Ryan Mead
Recruitment Consultant
T: 06- 12963210

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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.