Location: Netherlands (Hybrid)
Job Purpose:
The Quality Systems Specialist shall ensure maintenance of the compliance status of the QA Biologics and Small molecule (Branded and Generics)) quality systems, ensuring compliance with corporate standards and current regulatory requirements. Drives compliance and simplification in the GxP documentation processes. Ensure compliance in training processes and systems and is capable in all QA IT system applications. In addition, this person shall support the management of supplier qualification, in order to maintain the documentation (Quality Agreement, Audit Schedule, and CMO Assessment) organized, reviewed, and archived, quality-related matters derived from the CMO unit including complaints, quality agreement, change control, deviations, and overall quality oversight.
Major Responsibilities:
- Supports and maintains the Quality Management System in a compliant state by ensuring timely assessment of global corporate standards in comparison with current local procedures and current authorities’ expectations.
- Ensures timely implementation of global standards and procedures in the Quality unit by execution of associated GAP assessments against current local procedures in addition to executing any necessary implementation activities associated.
- Responsible for initiating and driving changes in good GxP documentation processes and databases
- Responsible for execution of training programs as per training systems ensuring timely completion of training requirements from all employees (management of training curriculums, coordination of continuous training, etc.) including annual GMP training coordination, on-the-job training, and induction training.
- Responsible for the document management system including control, issuance, approvals, reconciliations, and archiving of controlled documents, masters, forms templates, and approved documentation. etc.
- Responsible for periodic preparation of key quality metrics and implementing continuous improvement programs for the QMS.
- Support the coordination of external audit program (Audit Schedule preparation and maintenance; coordination of the risk assessment).
- Maintain and coordinate the process of inspection readiness
- Coordinate the review of the CMO and Affiliate’s Quality Agreement with QPs. Responsible for Quality Agreement Documentation archive. Responsible for maintenance and handling of complaints in the Track-Wise System in order to have these investigated in time. Follow up with Quality CMO Manager to review and ensure the completion of the investigation with the CMOs. Handle the due documentation /reports in a timely manner to affiliates and external partners.
- Responsible for issuing quality metrics and trend evaluation in terms of changes controls notification, deviations, recalls, or quality notification for the CMO units as applicable.
- Support the Quality Management Review process by organizing the meetings presentation, metrics of complaints, deviations, and changes controls. Preparation and archive of the participation lists and the minutes.
- Support in product release activities, as applicable
Education Qualifications (Graduate – Post Graduate):
- HBO or Bachelor’s Degree in (Bio-) Chemistry, Pharmacy, biological science, or similar education.
- Minimum of 3 years of relevant experience in (bio) pharmaceutical GMP environments.
- Good knowledge of EU GMP, and US CFRs.
- Well-versed in Microsoft Excel, PowerPoint, and MS Word.
- Experiences in Track-wise, Learning Management Systems (LMS) and e-Doc system
- Fluent in English
Work experience:
- Tenure: Minimum 3 years
- Industry: pharmaceutical
- Content areas: Manufacturing, QA /QC. Country QA office
Technical Competencies
- Good knowledge and experience in (bio-) pharmaceutical operations, QA/QC processes, and contract manufacturing.
- Good cGMP experience and knowledge, QA/QC and regulatory compliance (US, EU, and other international agencies)
- Good experience in quality management systems such as training, internal audit, change controls, deviations in regard to management, and continuous improvement.
- Experience interacting with external parties.
- Experiences with electronic Document Management, Training systems, and Track-wise
- Understanding of risk assessment and risk management fundamentals/tools
- Good knowledge of MS office and Windows-based computer applications.
Behavioral Competencies:
- Good interpersonal skills, excellent communication skills, good presentation, negotiations, and influencing skills
- Ability to effectively manage multiple, complex priorities and quick shifting of those.
- Team player, task-oriented, and keen on working in a cross-cultural working environment.
- People oriented with the tendency to help others and go beyond her/his area of responsibility
