- Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods and other industry practices.
- Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and being responsible for Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, implementing validation protocols and writing reports of validation results.
- Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides mentorship to Validation staff writing protocols and final reports
- Prepares equipment for qualification studies and implements qualification and validation studies according to approved protocols and SOPs
- Leads team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Approves various documents relating to area function, including those listed above.
- Provide direction and assign work to Validations Specialists to meet goals and timings
- Coordinates prioritization of activities with area management.
- Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.
- Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.
- Participates in regulatory and customer activities.
- Collaborates with functional departments to resolve issues.
- Leads projects and prepares status reports.
- Associate Manager QA Validation: 6+ years of related experience
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Associate Manager QA Validation - Rensselaer, United States - Regeneron Pharmaceuticals, Inc
Description
The QA Validation Fill Finish team is hiring an Associate Manager As the Associate Manager QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and
procedures.
In this role, a typical day may include:
To be considered for this role you must hold a Bachelors degree in Chemistry, Engineering, or Life Sciences and the following minimum amount of years of experience for each level:
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
#REGNQA
