Compliance Specialist - GXP/GLP DOC Management at Pharmaceutical Product Development (PPD)

As a Compliance Specialist you will execute quality and compliance processes across the organization. This role executes quality and compliance processes across the organization. Facilitates the tracking and reporting of quality and compliance activities. Maintains tools and materials and provides expertise to advance the vision of the department. 

Essential Functions:

• Processes and manages SOPs through the lifecycle in the Electronic Document Management System (EDMS).
• Researches issues, tracks metrics, and maintains reports and documentation related to quality and compliance activities.
• Administers quality and compliance processes and ensures appropriate execution and completion.
• Contributes to projects and process/quality improvement initiatives. 
• Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).

Job Qualification

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities: 

• Experience with SOPs/Controlled Documents
• Experience working in an Electronic Document Management System (EDMS)
• Laboratory experience will be an advantage
• Excellent oral andwritten communication skills
• Solid organizational and time-management skills
• Firm knowledge of the clinical trial process
• Knowledge and understanding of relevant GxP regulations and guidelines
• Effective problem solving skills
• Strongattention to detail
• Ability to work independently as required
• Strong computer skills; ability to learn and become proficient with appropriate software
• Ability to multitask and prioritize competing demands/work load
• Demonstrated flexibility and adaptability