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SalaryRemote
Role Summary:
The Senior QA Specialist, Global Product Quality implements and maintains the quality systems and tools required to manage and monitor the quality and compliance of GMP vendors that are utilized in the manufacturing, packaging, testing and distribution of Cerevel products.
Key Responsibilities
Ensure GMP compliance for outsourced manufacturing, packaging, labeling, testing & distribution activities
Review GMP documentation such as Master Batch Records, Specifications, Analytical Test Methods, Stability Protocols/Reports, Validation Protocols/Reports, Change Controls, and Label Proofs in support of manufacturing, testing, and packaging/labeling at various vendors
Review executed batch records and analytical data, to ensure timely disposition of drug substances, drug products and finished goods for use in clinical trials and commercial operations
Review Product Quality investigations, including but not limited to, quality events, deviations, CAPAs, out of trend (OOT), out of specification (OOS), Product Quality complaints, associated with manufacturing and analytical/stability testing
Ensure investigations are robust and properly documented (including root cause analysis, Product Quality impact assessment, CAPA)
Work proactively and effectively with vendors and respective Cerevel business functions to identify and mitigate quality risks/issues that may arise to maintain compliance and preserve projects’ timelines. Escalate issues to Manager in timely manner
Work collaboratively with Global Quality staff and other functional area partners to ensure GMP compliance with Cerevel and regulatory requirements
Support enhancements to electronic quality management system and other continuous improvement activities
Author/update Standard Operating Procedures, Work Practices, and other related documents
Additional responsibilities may be assigned based on business needs of a growing organization
Required Qualifications
4-5 years of related experience in pharmaceutical industry in Quality Assurance or Quality Control role supporting GMP Activities for clinical trials and/or commercial products
Understanding of GMP requirements and the drug development process
Technical writing experience; writing investigations, performing root cause analysis, and identifying CAPAs
Ability to handle interactions and resolve issues with internal customers and vendors in a tactful, professional, and effective manner
Highly motivated, flexible, and able to respond quickly to shifting priorities and meet deadlines, with excellent organizational skills and attention to detail
Strong verbal and written communication skills
Experience in authoring and implementing SOPs
Experience working in electronic quality management systems (Veeva or equivalent)
Ability to travel as needed, may be up to 20%
Desired Qualifications
Small molecule experience
Education
Bachelor’s degree in life science field (or equivalent) or engineering field relevant to pharmaceutical development preferred
Role Summary:
The Senior QA Specialist, Global Product Quality implements and maintains the quality systems and tools required to manage and monitor the quality and compliance of GMP vendors that are utilized in the manufacturing, packaging, testing and distribution of Cerevel products.
Key Responsibilities
Ensure GMP compliance for outsourced manufacturing, packaging, labeling, testing & distribution activities
Review GMP documentation such as Master Batch Records, Specifications, Analytical Test Methods, Stability Protocols/Reports, Validation Protocols/Reports, Change Controls, and Label Proofs in support of manufacturing, testing, and packaging/labeling at various vendors
Review executed batch records and analytical data, to ensure timely disposition of drug substances, drug products and finished goods for use in clinical trials and commercial operations
Review Product Quality investigations, including but not limited to, quality events, deviations, CAPAs, out of trend (OOT), out of specification (OOS), Product Quality complaints, associated with manufacturing and analytical/stability testing
Ensure investigations are robust and properly documented (including root cause analysis, Product Quality impact assessment, CAPA)
Work proactively and effectively with vendors and respective Cerevel business functions to identify and mitigate quality risks/issues that may arise to maintain compliance and preserve projects’ timelines. Escalate issues to Manager in timely manner
Work collaboratively with Global Quality staff and other functional area partners to ensure GMP compliance with Cerevel and regulatory requirements
Support enhancements to electronic quality management system and other continuous improvement activities
Author/update Standard Operating Procedures, Work Practices, and other related documents
Additional responsibilities may be assigned based on business needs of a growing organization
Required Qualifications
4-5 years of related experience in pharmaceutical industry in Quality Assurance or Quality Control role supporting GMP Activities for clinical trials and/or commercial products
Understanding of GMP requirements and the drug development process
Technical writing experience; writing investigations, performing root cause analysis, and identifying CAPAs
Ability to handle interactions and resolve issues with internal customers and vendors in a tactful, professional, and effective manner
Highly motivated, flexible, and able to respond quickly to shifting priorities and meet deadlines, with excellent organizational skills and attention to detail
Strong verbal and written communication skills
Experience in authoring and implementing SOPs
Experience working in electronic quality management systems (Veeva or equivalent)
Ability to travel as needed, may be up to 20%
Desired Qualifications
Small molecule experience
Education
Bachelor’s degree in life science field (or equivalent) or engineering field relevant to pharmaceutical development preferred
