Pharma QC Manager
One of our start-up pharmaceutical manufacturing facilities in King of Prussia, PA is seeking a Quality Control Manager to join their growing team.
This individual will be responsible for commissioning and validating a GMP QC Laboratory and oversight of the project planning to ultimately get the lab to operational by Q4 of this year.
Responsibilities include but are not limited to:
-Reporting progress on the commissioning of the GMP QC Laboratory including milestones, project goals and evaluating project resource needs and availability-Identify and report gaps or project constraints and develop solutions for successful implementation-Manages the inspection and testing of materials, parts, and products to ensure adherence to established quality standards and regulations Minimum Requirements Bachelor of Science in Chemistry, Chemical Engineering or related scientific field.
Experience commissioning and Validating a GMP QC Laboratory.
Minimum 5 years QC experience, method and instrument validation.
cGMPs and GMP requirements in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support.
Experience with eGxP Systems (ETQ, Trackwise, Veeva, SAP, OpenLab).
Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions.
Facilitate design, execution, monitoring and maintenance of local Quality System oversight, metrics and improvements including vendor monitoring, change controls, events, CAPA, escalation and risk management.
Exposure with multiple regulatory agencies across applicable GxPs during inspection.
Instrument qualifications IOQ, Validations, Calibration and operations.
Recommended Skills Calibration Change Control Chemical Engineering Chemistry Corrective And Preventive Action (Capa) Maintenance Estimated Salary: $20 to $28 per hour based on qualifications.
This individual will be responsible for commissioning and validating a GMP QC Laboratory and oversight of the project planning to ultimately get the lab to operational by Q4 of this year.
Responsibilities include but are not limited to:
-Reporting progress on the commissioning of the GMP QC Laboratory including milestones, project goals and evaluating project resource needs and availability-Identify and report gaps or project constraints and develop solutions for successful implementation-Manages the inspection and testing of materials, parts, and products to ensure adherence to established quality standards and regulations Minimum Requirements Bachelor of Science in Chemistry, Chemical Engineering or related scientific field.
Experience commissioning and Validating a GMP QC Laboratory.
Minimum 5 years QC experience, method and instrument validation.
cGMPs and GMP requirements in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support.
Experience with eGxP Systems (ETQ, Trackwise, Veeva, SAP, OpenLab).
Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions.
Facilitate design, execution, monitoring and maintenance of local Quality System oversight, metrics and improvements including vendor monitoring, change controls, events, CAPA, escalation and risk management.
Exposure with multiple regulatory agencies across applicable GxPs during inspection.
Instrument qualifications IOQ, Validations, Calibration and operations.
Recommended Skills Calibration Change Control Chemical Engineering Chemistry Corrective And Preventive Action (Capa) Maintenance Estimated Salary: $20 to $28 per hour based on qualifications.
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