QA Systems Manager
QA Systems Manager
Are you passionate about quality? Are you flexible? So this job is for you!
You are the next QA Systems Manager of our clients!
Our client is a pharmaceutical industry located in Hainaut areas.
As a QA Systems Manager, and in conjunction with the Associate Director of Quality Assurance, you will manage overall responsibility of Quality Assurance. Your main responsibilities will be:
- Develop, Implement, Maintain and Enhance Quality Systems and associated procedures;
- Involve in obtaining appropriate certification or accreditation (e.g. ISO/IEC 15189, CAP, GLP) as needed.
- Update and maintain Quality Assurance logs, databases, and generate metrics as needed;
- Provide GxP compliance, general QA support and guidance to personnel;
- Conduct internal (Facility, Study-Specific) and external audits;
- Review SOPs to ensure compliance with applicable regulatory and corporate standards;
- Develop and write SOPs;
- Participate in the development and delivery of internal training programs;
- Assist management in the preparation for regulatory agency inspections and sponsor specific inspections;
- Review and evaluate investigations, findings and resolutions, change control, CAPAs, non-conformances, and audit observations;
- Review CAPAs to determine effectiveness, perform trend analysis and compile summary reports;
- Involve in the recruitment and management of QA auditors;
- Keep up to date with current regulatory guidelines and regulations;
- Communicate compliance risks to senior management;
- Support equipment and software validations.
- You have a Bachelor’s degree in Life Sciences.
- Ideally, you have more than 5 years of quality and/or compliance related experience in CRO industry, working in a regulated environment with direct QA responsibility.
- You have a knowledge, an understanding, and an application of ISO/IEC 15189, GCP, EMA, OECD in relation to Good Laboratory Practice (GLP) and/or GCLP quality requirements.
- You have a knowledge in Drug Development, Validation of Analytical Methods, Quality Assurance and Regulatory Compliance, applied to various bioanalysis techniques (e.g. Immunoassays, Quantitation, etc.).
- You demonstrate documentation management skills, ability to design and implement quality processes.
- You have strong commitment to the accomplishment of tasks, self-motivated, excellent organizational skills.
- You have a proven flexibility to adjust to constantly changing priorities, handle multiple tasks, while maintaining quality.
- You have a high level of attention to detail and accuracy, excellent investigative techniques.
- You have an ability to work well in a team environment.
- You have a strong leadership, management and communication skills.
- You have an ability to identify and/or resolve quality issues, discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
- You are able to independently convey information with authority, handle high sensitive matters and interact with high-level contact with other organizations.
- Full time permanent contract.
- Diversified tasks and responsibilities and interesting projects.
- A professional, dynamic and stimulating work environment.
- Development opportunities.
- A competitive salary package including benefits, adapted to your experience and the context.
Contact me at 02 389 11 76 or firstname.lastname@example.org.