at Zoetis in Chicago Heights, Illinois, United States
Job Description
This position supports quality operations, compliance systems and objectives within the Chicago Heights, IL site. The candidate maintains a quality mindset and implements continuous improvement efforts and quality system initiatives to industry requirements. This position will interact with cross-functional groups such as Quality Control, Production, and Regulatory Affairs.
POSITION RESPONSIBILITIES:
Provide in plant/on floor support and guidance for cGMP product quality assurance and compliance for Manufacturing Operations and warehouse activities. Supply manufacturing and packaging operations Quality oversight - supplying the WHY as well as the HOW Quality is applied.
Responsible for preparation and maintenance of the site Validation Master Plan in line with current requirements.
Ensure approved quality systems are established and maintained.
Identify and communicate potential compliance gaps / risks to management.
Ability to provide Quality oversight on the manufacturing floor, including assessing deviations, incidents, and other compliance support.
Support and approve Manufacturing/Event Investigations and Corrective, Preventative Action (CAPA) and Laboratory Investigation records.
Educate and mentor site personnel on quality system requirements to achieve compliance goals.
Supports training management system and provides new employee, cGMP, refresher and general training.
Maintains and/or monitors compliance tracking systems and archive records, e.g., document control, deviation reporting, calibration, records retention, records destruct, etc.
Coordinates and investigates customer and supplier complaints.
Understands and follows Pharmaceutical GMP regulations.
Supports the release of finished goods documentation including technical review of batch records, labeling, COA, reprocessing instructions and lot deviations.
Supports product release and inventory management activities.
Ensure that Product release is in compliance with the registration files.
Assist in the development or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, etc.
Assist in facilitation, organization, and reporting of site FDA and regulatory compliance inspections. Assist with developing remediation efforts and FDA response when necessary.
Uphold a state of constant inspection readiness at the site.
Perform internal compliance, surveillance and focused audits. Develop and maintain audit plan and prioritize audit focus points, conduct reviews of technical documentation, identify risks, determine actions and prepare final report.
Provide support of the supplier management program including supplier audits and qualification of new suppliers.
Attend training to update personal skills and knowledge level.
Proactively and continuously improves Zoetis' internal processes and products with quality mindset.
Provide Regulatory Affairs compliance support and review on regulatory submissions, approvals, product labeling, registrations and other projects.
Interpret and communicate existing and/or new... For full info follow application link.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
