On behalf of my client, a global pharmaceutical company, we are collaborating with them on a new hire for a Quality Systems Specialist. This is a permanent opportunity with hybrid option.
Key Responsibilities
* Support the ongoing management of electronic Quality Management Systems (eQMS) related processes: documentation management, change controls, deviation management, CAPAs, customer complaints and laboratory investigations.
* Lead and execute development and/or modification of the company's eQMS.
* Develop and approve written procedures and other documents required in support of eQMS, including SOPs, WISOPs, technical agreements, quality policy and other compliance-related documents.
* Develop and maintain dashboard reports to ensure accurate, complete and consistent data is available, providing meaningful trending and analysis of data across all quality systems.
* Participate in the preparation of and delivery of associated training onsite.
* Collaborate with the corporate Quality Systems Specialist to contribute to the development and maintenance of quality systems.
* Work collaboratively with all site departments to ensure high levels of Good Manufacturing Practice (GMP).
* Participate in the preparation of and follow-up of regulatory and other external inspections.
Position Requirements
* 3+ years' experience in the pharmaceutical industry and a third-level qualification in a scientific discipline.
* Strong communication skills and interpersonal skills.
* Strong IT skills.
* Strong writing skills.
* Strong attention to detail.