Our client, who is an international pharmaceutical, is looking for QA Specialist II (morning, evening shifts and weekends) in Hoofddorp.
All applicants MUST have full legal authorization to work in the EU region independently and be fluent in both spoken and written English language.
About the department:
The QA Operations department supports a variety of activities from shop floor support of aseptic manufacturing activities, to finished product disposition. The department operates as one team with diverse roles and responsibilities, and operates as a high functioning team focused on ensuring the highest quality product reaches our patients in the most efficient manner possible. We are dedicated to open and transparent communication which drives our collaboration inside and outside of the department.
You'll be reporting to the Manager Quality Operations
In this role you will perform activities including, bu not limited to the following:
- Receipt and disposition of incoming materials.
- Review batch-related documentation, and ensure resolution of issues to expedite release of product.
- Perform preparations for product disposition/lot closure by the QP.
- Participate in Quality oversight of the packaging and shipping process for EU.
- Participate in Quality oversight of the product disposition process for EU.
- Ensure all product-related Deviations are initiated, investigated and resolved. Ensures that associated CAPAs are initiated and resolved, as needed.
- Ensure Change Controls are initiated, evaluated and implemented appropriately for all regulated changes.
- Contribute to the maintenance and reporting of metrics related to batch record review and product disposition in support of the Management Review.
- Contribute to the maintenance and reporting of Change Control metrics for Quality Systems in support of the Management Review.
- Contribute to the development and implementation of Quality on the floor processes, including batch record review.
- Intake and handling of product complaints for EU and/or related investigations.
- Liaise with other manufacturing sites, supply chain and CMO's, where applicable to facilitate smooth batch release for EU.
- Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
- Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
- Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
- Perform other duties as assigned.
- 4+ years of relevant experience in a GMP environment related field and a BS.
- 2 + years of relevant experience and a MS.
- Prior experience in pharmaceutical industry
- Minimum of 2 years of relevant experience
- Demonstrates working knowledge of GMPs and/or ATMPs.
- Demonstrates working knowledge of quality assurance systems, methods and procedures.
- Demonstrates knowledge of FDA / EMEA standards and quality systems.
- Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates good verbal, written, and interpersonal communication skills.
- Demonstrates proficiency in Microsoft Office applications.
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
What do we offer
- Contract via Kelly for 40 hours duration 12 months possible extension
- Start date: 1 March 2021
- Salary indication depending on experience!
Please do contact Marcella Henryati, Recruitment Consultant
When interested please apply with your English resume on our website: www.kellyservices.nl
It's more than a job. It's passion. Our vision is to provide the world's best workforce solutions. We are authentic, the industry founder. We believe in relationships, not transactions. We value teamwork, realizing that we are stronger together than as individuals. We take seriously the promises we make. We are passionate, dedicated and driven to excel. With us it has never been about being the biggest. It has always been about being the best and doing the right thing.
At our core, we are a community. Each day we welcome into our community the varied talents of all people who embrace our culture of service, teamwork and integrity. We offer the opportunity to work with the best companies in the world, and to make a difference in the communities in which we live and work.
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