Compliance Specialist Ii

Our client is a world leading contract development and manufacturing organization of pharmaceutical products. Located in France, the USA, Brazil, and China, we provide comprehensive innovation & development services to fulfil every aspect of contract pharmaceutical manufacturing needs. They specialize in unit dose manufacturing and our expertise includes an extensive range of unit dose packaging, such as Blow-fill-seal (BFS). In addition, we also manufacture preservative-free multidose, pharmaceutical bottles, sprays, tablets, tubes, suppositories and pessaries.

JOB SUMMARY:

Responsible for the development, implementation and on-going continuous improvement of the site's Pharmaceutical Quality System. In addition, this position supports the site training function through the establishment and execution of a comprehensive training system. Specialist effectively conducts and supports problem investigations and disposition of material and finished goods. Specialist serves as a frequent inter-organizational contact and represents the department on project teams. Will review and approve a wide variety of GMP related documents. Specialist interacts with manager and director levels of management in all departments in developing solutions and conveying information.

ESSENTIAL DUTIES / RESPONSIBILITIES:

Governance Processes Aligned with ICH Guidance

• Develops and implements Site Quality Management and Governance processes which are aligned with ICH requirements.
• Develops and maintains Site Quality Plan.
• Develops and implements risk assessment processes associated with the Site Quality Management and Governance processes.
• Aids in the management and execution of the Quality Council.

Effective, Efficient Quality System

• Develops, implements, and consistently improves the site's Pharmaceutical Quality System to ensure regulatory compliance.
• Ensures the Pharmaceutical Quality System is efficient for the business while maintaining compliance.

GMP Training SOP & Process

• Develops, implements and monitors Site GMP Training Program.
• Provides leadership to organization to ensure Training system is implemented in all areas

Quality Guidance & Advice

• Provides appropriate Quality Assurance consultation to project teams. Consultation must meet current regulatory requirements and be appropriate for the business.
• Provides appropriate Quality Assurance consultation and approval concerning equipment, facility, and utility changes, IT system implementation and changes, validation, and process and procedure (e.g., Standard Operating Procedures, Analytical Methods, Specifications) changes.

Safe, Effective Products

• Provides Quality Assurance review and approval of deviations. Review includes the determination that deviation investigations are sound, meet current regulatory requirements and ensure product is safe and effective.
• Ensures management is notified of product and process risks.
• Provides leadership and support of all external audits, including organization of departments to ensure a smooth audit process.
• Provides Quality Assurance review and approval of product and process related documentation including risk assessments.

REQUIRED EDUCATION

QUALIFICATIONS/EXPERIENCE:

• A minimum 5 years Quality Assurance experience in FDA regulated environment is preferred.
• Degree requirement may be substituted with a minimum of 8-10 years of Quality Assurance experience in FDA regulated environment at an equivalent level.

SPECIFIC SKILLS

• A comprehensive understanding of current regulatory requirements and ability to interpret them. QA/compliance experience in manufacturing, facility operation, laboratory compliance and quality systems. Experience in leading audits and supporting regulatory inspections. Good teamwork and project management skills (including the ability to lead teams). Requires excellent communication, interpersonal and organization skills.
• Must be able to recognize situations where there is a potential impact on product quality, safety, identity and purity. Encourages self and others to consider innovative approaches to addressing problems and developing solutions that are effective and compliant. Responsible for developing and ensuring full implementation of an appropriate solution.