Vacancy caducado!
Responsibilities
Provide support and manage the PMO system, including scheduling and work in conjunction with QA in the monthly issuance of PMOs. Ensure timely execution and follow up. Assist with the Calibration program by providing support for documentation, scheduling and follow-up as applicable. Prepare the Compressed Gas Trending Report and provide input for Annual Product Review and Annual Report
Provide daily coverage to support production and quality control areas. Perform periodic audit of facility areas to ensure compliance with cGMP, safety, and internal requirements.
Assist in investigations in response to any facility events encountered during manufacturing or out-of-tolerance calibration results for critical equipment or out of frequency PMOs. Follow up on corrective/preventive actions as applicable
Assist in ensuring cGMP audit observations are implemented with regard to conducting a review of processes and documentation, as needed.
Identify and communicate cGMP compliance deficiencies to Management, recommend appropriate corrective actions as applicable.
Provide signatory review for SOPs and PMOs to ensure compliance with cGMP, regulatory and internal requirements such as company guidelines and approved procedures.
Provide support to regarding the Change Control System by providing documentation and supporting data to include in the Change Control Request.
Provide support in the implementation of departmental and site projects as needed
Requirements: Bachelor's Degree in Science, with 4-5 years experience in a GMP regulated environment.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.#GD-SP#LI-SPAt Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Vacancy caducado!