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Our client who specializes in the pharmaceutical industry is looking for a Deputy Analytical QA Manager. While liasing with the AQA Manager, Head of Quality and QC Manager, you will be responsible for the following:
Assist in managing the Analytical Quality Assurance (AQA) team.
Train junior team members within the AQA unit
Generate Quality KPIs related to the AQA unit
Maintain records of all quality documentation
Conduct Analytical Method Transfers and Validation activities
Prepare analytical worksheets in line with registered testing methodologies
Coordinate and review analytical documentation
Issue Certificates of Analysis
Review Analytical Protocols and Reports
Approve Instrument Qualification Protocols and Reports
Investigate OOX results (Chemistry and Microbiology)
Perform laboratory deviation investigations and assist in quality investigations
Actively participate in the review and implementation of CAPAs
Organize trends in Analytical Laboratory Testing, Purified Water testing, Environmental Monitoring results, and other required trends
Provide data and support for yearly Product Quality Reviews
Participate in self-inspections and external audits, providing required documentation
Prepare for regulatory and client audits
Assist in Quality Assurance activities prior to batch certification
Monitor and implement Pharmacopeial updates
Contribute to the implementation of new systems, Quality Assurance duties, and other projects as required
Requirements
5+ years of proven experience working in a laboratory environment within the Pharmaceutical Industry
Proven experience in Analytical Method Transfers and Validations
Our client who specializes in the pharmaceutical industry is looking for a Deputy Analytical QA Manager. While liasing with the AQA Manager, Head of Quality and QC Manager, you will be responsible for the following:
Assist in managing the Analytical Quality Assurance (AQA) team.
Train junior team members within the AQA unit
Generate Quality KPIs related to the AQA unit
Maintain records of all quality documentation
Conduct Analytical Method Transfers and Validation activities
Prepare analytical worksheets in line with registered testing methodologies
Coordinate and review analytical documentation
Issue Certificates of Analysis
Review Analytical Protocols and Reports
Approve Instrument Qualification Protocols and Reports
Investigate OOX results (Chemistry and Microbiology)
Perform laboratory deviation investigations and assist in quality investigations
Actively participate in the review and implementation of CAPAs
Organize trends in Analytical Laboratory Testing, Purified Water testing, Environmental Monitoring results, and other required trends
Provide data and support for yearly Product Quality Reviews
Participate in self-inspections and external audits, providing required documentation
Prepare for regulatory and client audits
Assist in Quality Assurance activities prior to batch certification
Monitor and implement Pharmacopeial updates
Contribute to the implementation of new systems, Quality Assurance duties, and other projects as required
Requirements
5+ years of proven experience working in a laboratory environment within the Pharmaceutical Industry
Proven experience in Analytical Method Transfers and Validations
Education and Experience
Bachelor Degree in a related science positon
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