Quality Assurance Specialist - Biotech Multinational
Location: NOORD-HOLLAND, NetherlandsQA Specialist
Company: Multinational company specialized in Cell Therapy
Start: Preferably ASAP (aim is 15/05 or 01/06)
Location: Amsterdam area
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.
In this role, you will perform activities including, but 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.
Education
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 is preferred
Knowledge/Experience
Required:
- 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
Preferred:
- General knowledge of aseptic manufacturing processes
- Experience with Identifying, writing evaluating and closing Deviations and CAPA
- Knowledge of ATMPs
- Experience with international supply chains for Materials and Product distribution
Are you interested or do you have questions? Feel free to reach out by replying to this vacancy.
Company: Multinational company specialized in Cell Therapy
Start: Preferably ASAP (aim is 15/05 or 01/06)
Location: Amsterdam area
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.
In this role, you will perform activities including, but 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.
Education
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 is preferred
Knowledge/Experience
Required:
- 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
Preferred:
- General knowledge of aseptic manufacturing processes
- Experience with Identifying, writing evaluating and closing Deviations and CAPA
- Knowledge of ATMPs
- Experience with international supply chains for Materials and Product distribution
Are you interested or do you have questions? Feel free to reach out by replying to this vacancy.
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