Job Description

Purpose

To assist the Head of Quality Assurance (QA) by performing QA operational coordination and support activities, including but not limited to maintenance of:

• The electronic Quality Management System (eQMS)
• QA audit and inspection readiness files
• Quality improvement documentation
• Other training files and archived documents and databases related to the QA function.
• To support preparation and hosting of visitors for QA-related activities such as regulatory inspections and system audits
• To support the Head of QA by coordinating status information for quality improvement activities such as audits, inspections, investigations and Corrective Actions and Preventive Actions (CAPAs)
• To support the conduct of audits or other quality assessments, if required

Planning and Execution

• Lead the OPUS QMS system administrator activities for the Management of Controlled Documents, assignment of Training, and monitoring of audit, CAPA and training activity completion.
• Oversee eQMS review cycles and issue new and revised documents.
• Set up and maintain QA & eQMS files, where appropriate

Financial Outcome

• Monitor and provide QA Management with reports on compliance with standardized practices for the eQMS.
• Act as a process expert regarding maintenance of the eQMS (e.g. user and access management, new starter and refresher training)
• Maintain up-to-date status information and supporting documentation for quality-related activities, such as audits, inspections, CAPAs and other quality issues.
• Adhere to requirements of the OPUS Quality Management System, working practices and Good Clinical Practice/Good Manufacturing Practice regulations, and ensure training in these areas is always kept up to date.

Innovation

• Monitor QMS data/activities to identify potential trends for collaboration with process owners to drive quality improvement.

External/Internal Relationship

• Represent OPUS as the liaison with Corporate Headquarters in support of the Global system and associated processes.

Educational Requirements

• Ideally a BSc (or equivalent) in life sciences, nursing or a combination of education and demonstrable QA experience gained within a contract research organization (CRO), pharmaceutical or biotechnology company

Experience

• Previous hands-on experience with electronic QMS systems, including training and system administration

Technical Skills

• Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Familiarity with common applications used in GxP Quality Management activities

Cognitive Skills

• Analytical problem-solving skills

Language/Interpersonal Skills

• Strong written and spoken English.
• Excellent communication skills (verbal and written).
• Presentation skills are desirable but not essential.
• Excellent organization and time management skills
• Able to interact effectively at all levels within the organization, as well as with external partners.
• Ability to work independently with minimal supervision.
• Diplomatic and tactful in liaising with staff and management.

Other

• May be required to occasionally work beyond normal business hours including evening and/or weekend (e.g. teleconference with counterparts of Headquarters) as business needs dictate

Physical Demands

• Work is generally sedentary in nature, but may require standing, walking, grasping, and lifting/moving up to 15 pounds (e.g. to shred documents, to maintain a neat and organized work environment, and to lift paper supplies, and boxes and files). Ability to read printed materials and written information on a computer screen is required

Work Environment

• The noise level in the work environment is usually quiet.

Business Travel

• This role requires minimal travel.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this role.

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