Quality Assurance Officer

PrimeVigilance, an Ergomed brand, was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.

The Quality Assurance Officer provides support to the Quality Assurance (QA) team for all audit, inspection and Corrective and Preventative Actions (CAPA) activities, both internally and externally. Support for other QA activities could also be requested.

Contributes to achieving company's goals and objectives.

 The Quality Assurance Officer will support all audit activities within PrimeVigilance and will work with the Auditing team and Quality team s to ensure audits are delivered in line with PrimeVigilance and procedures and global regulations.

The Quality Assurance Officer will oversee all activities described, including but not limited to: 

Audit Support:

• Supports PrimeVigilance functional teams pre-, during and post-audits by clients or by internal QA function
• Supports local client audit hosting and inspection support
• Assist in client specific requests for audit scheduling

Administrative support

•  Support QA in the tracking of audit status and deliverables

CAPA Support Activities

• Supports in tracking of the client audit CAPAs.
• Support in the facilitation of CAPA response
• Input into the global audit CAPA tracker

Other Supportive Responsibilities: 

• The Quality Assurance Officer will support the PrimeVigilance Senior Leadership teams as needed.
• Other QA support as needed.

IF LINE MANAGER (optional):

• Line management tasks (periodic appraisals, performing holiday approval, ensuring adequate cover is in place to meet operational requirements for existing and new contracts)
• Mentoring and training of new and more junior employees as required.

University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master’s degree in a scientific discipline, or equivalent advanced degree with experience. Or equivalent industry experience

Essential

• Previous experience in the pharmaceutical and/or regulated industry in a quality setting – preferably in Pharmaceuticals or Healthcare
• Thorough understanding of the principles of Quality Assurance
• Knowledge of national regulations related to Pharmacovigilance and Medical Information
• Experience of participating in audits and inspections
• Excellent communication and facilitation skills within a global organisation
• Proactive and self-motivated
• Organization skills, including attention to details and multitasking
• English advanced – spoken and written
• Literate in Microsoft Office Use

Desirable

• Familiarity with international regulations is desirable

All your information will be kept confidential according to EEO guidelines.

Our Offer:

• Work within a successful, highly – qualified and dynamic team
• Professional training and career development in a fast-growing healthcare company