Scheduling, preparing, conducting and reporting local and global supplier audits to assess the level of compliance with current regulations and guidelines. This includes leading complex audits (“for-cause”, leading audit teams, etc.)
Follow-up with suppliers and GMP service providers to ensure corrective actions is taken to satisfactory close audit observations.
Appropriately escalate any compliance issues.
Meet the requirements defined in quality manuals, procedures, and guidances.
Materials Management Responsiblities:
Conduct material, consumable, and service provider risk assessments.
Participate or lead the preparation and/or review of documentation used to establish supplier quality requirements, when needed.
Contribute to the approval process of a new supplier or GMP service provider.
Assist with maintaining the approved supplier list at the ATC
Review, redline, and/or approve GMP documents (examples: deviations, change controls, procedures, and protocols) when needed;
Business Related Responsibilities:
Assist purchasing, manufacturing and support groups in identifying and managing material suppliers and GMP Service Providers.
Lead and/or support internal inspections.
Participate and/or lead site mock inspections, when needed.
Actively participate in onsite regulatory inspections.
Influence customers (internal & external) and partners when improvement needs are identified
Assist in the preparation of organizational metrics and trending of audit findings, when required.
Network with other business partners on best practices.
Auditing Skill/Knowledge Development:
Provide mentorship to less experienced auditors.
· Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.
Complete required training and qualifications for the roles.
Be continually aware of current industry trends and regulatory agency interpretation of requirements.
Attend training courses, conferences or association meetings to continue to gain knowledge and to share such information with other members of the group or company to increase their awareness, as assigned.
Participate or lead divisional improvement efforts, including departmental/site teams, as assigned.
Bachelor’s Degree of Science in chemistry, microbiology, physical or biological sciences, engineering or other technical area.
External certification: ASQ Certified Quality Auditor (CQA) preferred, but not required.
Experience:
A minimum of 5 years of relevant experience(s) with quality, manufacturing within the pharmaceutical environment
Pharmaceutical industry auditing experience (minimum 5 years).
Required Skills:
· Ability to interpret and apply regulations, regulatory guidance, codes and public expectations and identify and recommend compliance changes as appropriate.
· Experience with regulatory inspections
· Experience working on a global team and sharing knowledge.
· Ability to influence and manage change/conflict
Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.
· Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization and to the suppliers.
· Good analytical/problem-solving skills.
Proven ability to think and analyze from a process perspective.
· Establish and maintain effective working relationships at all levels internal and external to Union Agener.
Deliver constructive feedback to customers while providing a high level of customer service.
Proficiency with computer systems including Microsoft Office products
Root cause analysis/troubleshooting skills
Responsible for maintaining a safe work environment and working safely.
Other Information:
· Domestic and international travel is required to fulfill these job responsibilities.
· Must be able to travel up to 50%
· This position is onsite and is located at the Union Agener site in Augusta, Georgia.
Union Agener Animal Health, located in the city of Augusta, Georgia, United States, is a biotechnology unit dedicated to animal health.
The plant was acquired in October 2018 by Fernando de Castro Marques, a majority shareholder of União Química, one of the largest groups in the pharmaceutical industry in Brazil. “Now we are in full control of operations and we will begin production of new Posilac® batches to fully satisfy the demands of the American market and other export markets,” says Fernando de Castro Marques, president of Union Agener and Grupo União Química Farmacêutica.
The unit has state-of-the-art technology and produces, on a large scale, Posilac® product (rbST – recombinant bovine somatotropin), used to increase milk production. The plant has 129,000 m² of total area, of which 24,000 m² is built, with a high-tech vertical production. The product is marketed globally under the trademarks Posilac® and Lactotropin.
This factory complex is FDA certified, having the product present in 22 countries, including the USA.
