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Quality Assurance - Qualified Person

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Barrington James

2021-12-03 13:51:51

Job location Amsterdam, Noord-Holland, Netherlands

Job type: fulltime

Job industry: Other

Job description

*Essential Responsibilities*

* Review of batch documentation and manufacturing process to support the decision to release the product in accordance with all licensing and GMP requirements

* Reviewing and approving deviations, CAPA, Change Control, Complaints and procedures

* Represent QA in various (development and improvement) projects and advise on the adequacy of validation of facilities, equipment and new products / processes, including design strategies

* Supervising and coordinating inspections by external (regulatory) authorities (IGJ), as well as supporting the QA audit function to ensure GMP compliance

* Establish and maintain QMS

* Maintaining current knowledge of pharmaceutical legislation and best practices and implementation thereof.

Qualifications / Requirements

* Qualified to work as a QP

* Relevant experience as QP in the GMP production and QA environment within a pharmaceutical company

* Knowledge of sterile product manufacturing and associated QA requirements, including aseptic preparation

* Fluent Dutch and excellent English

* Able to work under pressure and make good, timely decisions.

Desired characteristics

* Energetic team player with excellent communication and social skills

* Promote a culture of continuous improvement

* Ability to communicate effectively with all levels of personnel within all cross functional departments and regulatory inspectors

* Living in the Eindhoven region.

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