Job DescriptionResponsible for execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with functional teams to determine root cause and potential preventative/corrective actions and ensures timely closure of CAPA. Responsible for performing QRM for manufacturing equipment and process, risk communication and periodic review or QRM. Responsible for conducting regular walkthroughs in manufacturing area to ensure compliance to Confidencial procedures and policies. Responsible for change management in manufacturing area, plan creation, oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business. Responsible for tracking and implementation of inspectionreadiness activities. Creates and establishes processes and procedures to ensure compliance and adherence to Confidencial Quality System requirement. QualificationsMust:HaveBachelors/Masters Degree and 5 to 8 years of experience. Experience in CCF, CAPA and QRM activities. Effective Facilitation skills. Proficiency in MS Office Word, Excel andPowerPoint. Excellent verbal and written communication and presentation skills. Nice:To:HaveMasters degree and relevant pharmaceutical experience. Knowledge of Quality Management System. Expert knowledge of GMP, Data integrity. Experienced in Regulation inspections. Confidencial is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Quality Assurance and ControlLI:PFE