What are the responsibilities and job description for the Manager, Quality Assurance position at Aurobindo Pharma USA, Inc.?
Division Overview:
Acrotech Biopharma INC, was formed as a global platform to commercialize innovative proprietary medications. The company aims to launch scientifically advanced products to address unmet needs and deliver value to patient's as well as all healthcare stakeholders. Acrotech aspires to be a patient focused, research based organization that strives to launch treatments which are accessible to patients that need them.
Job Overview:
The Quality Assurance Manager will be responsible for the vendor management program, including GMP/GCP audits of contracted organizations. Responsibilities include hosting or assisting with client audits and regulatory inspections managing the vendor qualification and oversight programs, conducting/managing audits of vendors including CMOs (drug product, API and raw material), CROs, contract packagers, contract laboratories, and distributors. Processes audited include sterile production, biotech manufacturing, solid oral dose and ointment manufacturing. This position may assist with product disposition and quality agreements, as needed, as well as a review of investigations and improving/creating SOPs to support the vendor management process. This is an on-site position. This position reports directly to the Senior Director of Quality Assurance. There are no direct reports under this position.
Responsibilities:Vendor Management Responsibilities (Primary):
Own the vendor management process
Manage audit schedules, perform GxP audits (domestic and international), write audit reports and manage responses
Manage the Vendor List and Approved Vendor List
Perform audit report reviews and approve audit reports by 3rd party auditors
Support client audits and regulatory inspections as host or direct support
Quality Assurance Responsibilities (Secondary):
Review of batch records/product disposition, as needed
Review of deviations/OOS/ complaint investigations/ change controls, as needed
Review or author/update SOPs
Assist with the review of other supporting documentation
Author/assist with Quality Agreements
Internal Audits
Assist with Regulatory Agency inspections/Marketing Partner audits
Qualifications - Skills & Requirements:
Highly organized with great attention to detail
Strong computer skills, including MS Office (Word, Excel, PowerPoint); SharePoint
Strong knowledge of global regulations for commercial & clinical operations
Education & Experience:
7 years experience in Pharmaceutical Quality Assurance required
5 years experience performing GMP audits required
Experience with GMP & GCP audits preferred
Bachelor’s Degree from accredited university
ASQ Quality Auditor Certification preferred
Physical Requirements: OFFICE POSITION - While performing the duties of this job the employee is required to: •Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment •Specific vision abilities required by this job include close vision requirements due to computer work •Light to moderate lifting is required •Moderate noise (i.e. business office with computers, phone, and printers, light traffic). •Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional Physical Requirements:
No Additional Requirements
Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
Acrotech Biopharma INC, was formed as a global platform to commercialize innovative proprietary medications. The company aims to launch scientifically advanced products to address unmet needs and deliver value to patient's as well as all healthcare stakeholders. Acrotech aspires to be a patient focused, research based organization that strives to launch treatments which are accessible to patients that need them.
Job Overview:
The Quality Assurance Manager will be responsible for the vendor management program, including GMP/GCP audits of contracted organizations. Responsibilities include hosting or assisting with client audits and regulatory inspections managing the vendor qualification and oversight programs, conducting/managing audits of vendors including CMOs (drug product, API and raw material), CROs, contract packagers, contract laboratories, and distributors. Processes audited include sterile production, biotech manufacturing, solid oral dose and ointment manufacturing. This position may assist with product disposition and quality agreements, as needed, as well as a review of investigations and improving/creating SOPs to support the vendor management process. This is an on-site position. This position reports directly to the Senior Director of Quality Assurance. There are no direct reports under this position.
Responsibilities:Vendor Management Responsibilities (Primary):
Own the vendor management process
Manage audit schedules, perform GxP audits (domestic and international), write audit reports and manage responses
Manage the Vendor List and Approved Vendor List
Perform audit report reviews and approve audit reports by 3rd party auditors
Support client audits and regulatory inspections as host or direct support
Quality Assurance Responsibilities (Secondary):
Review of batch records/product disposition, as needed
Review of deviations/OOS/ complaint investigations/ change controls, as needed
Review or author/update SOPs
Assist with the review of other supporting documentation
Author/assist with Quality Agreements
Internal Audits
Assist with Regulatory Agency inspections/Marketing Partner audits
Qualifications - Skills & Requirements:
Highly organized with great attention to detail
Strong computer skills, including MS Office (Word, Excel, PowerPoint); SharePoint
Strong knowledge of global regulations for commercial & clinical operations
Education & Experience:
7 years experience in Pharmaceutical Quality Assurance required
5 years experience performing GMP audits required
Experience with GMP & GCP audits preferred
Bachelor’s Degree from accredited university
ASQ Quality Auditor Certification preferred
Physical Requirements: OFFICE POSITION - While performing the duties of this job the employee is required to: •Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment •Specific vision abilities required by this job include close vision requirements due to computer work •Light to moderate lifting is required •Moderate noise (i.e. business office with computers, phone, and printers, light traffic). •Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional Physical Requirements:
No Additional Requirements
Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
