What are the responsibilities and job description for the Quality Assurance Manager 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:
This position is responsible for product and vendor management of sterile and non-sterile contracted drug product and API manufacturers, packagers, testing labs, raw material manufacturers and distribution of commercial and clinical product, as a virtual manufacturer. This position has full product lifecycle oversight and is responsible for product disposition, the review and approval of batch records and testing records, specifications, review and approval of deviations, OOS and customer complaint investigations, including associated CAPA, change controls (manufacturing, testing, other) review and approval of validation protocols and reports, (manufacturing; packaging; test methods), equipment and facility qualification protocols and reports, and label approval.
This position reports directly to the Sr. Manager of Quality Assurance. There are no direct reports with respect to this position.
Responsibilities:Quality Assurance CMC Responsibilities:
Oversee contracted organizations for the manufacturing/packaging/ testing/ distribution of raw material through finished product (validation, process and method transfers, MBR, etc.)
Oversee Contracted Testing Organizations; submit purchase requests; identify budget requirements
Consolidate, review & approve Certificates of Analysis
Review/Approve deviations/OOS
Conduct investigations and write investigation reports for deviations from procedures.
Author/Review SOPs, specifications and work instructions to ensure internal processes conform to GMPs and regulations.
Manage vendor change controls and coordinate with Marketing Partners
Perform Batch Record Review & Disposition of API, Intermediates and Finished Drug Products.
Manage stability program & reference standards
Perform trend analysis of data from stability program and lot release testing when necessary.
Perform risk assessment of non-conformances and change controls having potential impact on product quality.
Author Annual Product Reviews (APRs)
Report monthly metrics and consolidate/trend stability data for APRs
Manage Product Complaints for respective products
Author/Revise Quality Agreements
Technical Support for marketing partners
Support client/regulatory audits/inspections.
May assist with audits of contracted facilities.
Qualifications - Skills & Requirements:
Attention to detail; well organized
Strong computer skills
Proficient in Microsoft Office Systems, Oracle a plus
Education & Experience:
Bachelor’s Degree in pharmacy, chemistry, biology or microbiology or related field
5 years experience in the Pharmaceutical Industry
Biopharmaceutical experience a plus
Sterile quality experience; firm understanding of Annex 1 preferred
CRO experience preferred
ASQ Certification preferred
Travel up to 5% a possibility both domestic and international
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:
This position is responsible for product and vendor management of sterile and non-sterile contracted drug product and API manufacturers, packagers, testing labs, raw material manufacturers and distribution of commercial and clinical product, as a virtual manufacturer. This position has full product lifecycle oversight and is responsible for product disposition, the review and approval of batch records and testing records, specifications, review and approval of deviations, OOS and customer complaint investigations, including associated CAPA, change controls (manufacturing, testing, other) review and approval of validation protocols and reports, (manufacturing; packaging; test methods), equipment and facility qualification protocols and reports, and label approval.
This position reports directly to the Sr. Manager of Quality Assurance. There are no direct reports with respect to this position.
Responsibilities:Quality Assurance CMC Responsibilities:
Oversee contracted organizations for the manufacturing/packaging/ testing/ distribution of raw material through finished product (validation, process and method transfers, MBR, etc.)
Oversee Contracted Testing Organizations; submit purchase requests; identify budget requirements
Consolidate, review & approve Certificates of Analysis
Review/Approve deviations/OOS
Conduct investigations and write investigation reports for deviations from procedures.
Author/Review SOPs, specifications and work instructions to ensure internal processes conform to GMPs and regulations.
Manage vendor change controls and coordinate with Marketing Partners
Perform Batch Record Review & Disposition of API, Intermediates and Finished Drug Products.
Manage stability program & reference standards
Perform trend analysis of data from stability program and lot release testing when necessary.
Perform risk assessment of non-conformances and change controls having potential impact on product quality.
Author Annual Product Reviews (APRs)
Report monthly metrics and consolidate/trend stability data for APRs
Manage Product Complaints for respective products
Author/Revise Quality Agreements
Technical Support for marketing partners
Support client/regulatory audits/inspections.
May assist with audits of contracted facilities.
Qualifications - Skills & Requirements:
Attention to detail; well organized
Strong computer skills
Proficient in Microsoft Office Systems, Oracle a plus
Education & Experience:
Bachelor’s Degree in pharmacy, chemistry, biology or microbiology or related field
5 years experience in the Pharmaceutical Industry
Biopharmaceutical experience a plus
Sterile quality experience; firm understanding of Annex 1 preferred
CRO experience preferred
ASQ Certification preferred
Travel up to 5% a possibility both domestic and international
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.
