Lead Investigator
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Job title:
Lead Investigator, Global APQR & Complaint Operations
Job description:
A leading global life sciences company is looking for experienced and talented candidates for the position of Lead Investigator Global APQR & Complaint Operations based in South East Asia including Malaysia.
Responsible for executing, reviewing and approving records in the Quality Management System (including Complaints, Global Change Control ownership, Discrepancy Investigations, CAPA, etc.).
Identifies, analyzes, and drives the resolution of issues related to or identified with complaints processes.
Provides training and guidance as needed regarding the complaints process, including planning and the implementation of procedures.
Contributes to performance metrics and overall Quality assessment and reporting as part of the complaints business process.
Lead product complaint investigations (critical and non-critical) with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards. Collaborate with departments (e.g. Affiliates, Manufacturing/Packaging Sites, Device Quality) to establish appropriate, efficient, and timely investigation strategies.
Lead root cause analysis and present at QRB.
Manage Global Complaints for Devices that were manufactured, packed, labeled and/or shipped by Commercial Supply or on behalf of Global Supply Chain.
Initiate, coordinate, and track complaints as Lead Investigator or act as complaint QA and close/approve complaints.
Requirements:
B.A., B.S. or Higher degree (preferably in Life Science)
Minimum 6 years of releant experience in the pharmaceutical, biopharmaceutical or medical device industry with experience in technical writing.
Technical expertise in small and large molecule drug substance and drug product manufacturing processes as well as associated control and documentation systems (e.g., MELODI, SAP, ValDam, Veeva).
Experience with using quality-related tools, including Six Sigma / DMAIC, for problem solving and decision making.
Experience collaborating in a global setting to support product teams and global quality initiatives.
Experience with enterprise database, collaboration platforms, and analytics (IT platforms).
CEI: R2090154 | Licence No.: 22S1313
Lead Investigator, Global APQR & Complaint Operations
Job description:
A leading global life sciences company is looking for experienced and talented candidates for the position of Lead Investigator Global APQR & Complaint Operations based in South East Asia including Malaysia.
Responsible for executing, reviewing and approving records in the Quality Management System (including Complaints, Global Change Control ownership, Discrepancy Investigations, CAPA, etc.).
Identifies, analyzes, and drives the resolution of issues related to or identified with complaints processes.
Provides training and guidance as needed regarding the complaints process, including planning and the implementation of procedures.
Contributes to performance metrics and overall Quality assessment and reporting as part of the complaints business process.
Lead product complaint investigations (critical and non-critical) with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards. Collaborate with departments (e.g. Affiliates, Manufacturing/Packaging Sites, Device Quality) to establish appropriate, efficient, and timely investigation strategies.
Lead root cause analysis and present at QRB.
Manage Global Complaints for Devices that were manufactured, packed, labeled and/or shipped by Commercial Supply or on behalf of Global Supply Chain.
Initiate, coordinate, and track complaints as Lead Investigator or act as complaint QA and close/approve complaints.
Requirements:
B.A., B.S. or Higher degree (preferably in Life Science)
Minimum 6 years of releant experience in the pharmaceutical, biopharmaceutical or medical device industry with experience in technical writing.
Technical expertise in small and large molecule drug substance and drug product manufacturing processes as well as associated control and documentation systems (e.g., MELODI, SAP, ValDam, Veeva).
Experience with using quality-related tools, including Six Sigma / DMAIC, for problem solving and decision making.
Experience collaborating in a global setting to support product teams and global quality initiatives.
Experience with enterprise database, collaboration platforms, and analytics (IT platforms).
CEI: R2090154 | Licence No.: 22S1313
Job title:
Lead Investigator, Global APQR & Complaint Operations
Job description:
A leading global life sciences company is looking for experienced and talented candidates for the position of Lead Investigator Global APQR & Complaint Operations based in South East Asia including Malaysia.
● Responsible for executing, reviewing and approving records in the Quality Management System (including Complaints, Global Change Control ownership, Discrepancy Investigations, CAPA, etc.).
● Identifies, analyzes, and drives the resolution of issues related to or identified with complaints processes.
● Provides training and guidance as needed regarding the complaints process, including planning and the implementation of procedures.
● Contributes to performance metrics and overall Quality assessment and reporting as part of the complaints business process.
● Lead product complaint investigations (critical and non-critical) with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards. Collaborate with departments (e.g. Affiliates, Manufacturing/Packaging Sites, Device Quality) to establish appropriate, efficient, and timely investigation strategies.
● Lead root cause analysis and present at QRB.
● Manage Global Complaints for Devices that were manufactured, packed, labeled and/or shipped by Commercial Supply or on behalf of Global Supply Chain.
● Initiate, coordinate, and track complaints as Lead Investigator or act as complaint QA and close/approve complaints.
Requirements:
● B.A., B.S. or Higher degree (preferably in Life Science)
● Minimum 6 years of releant experience in the pharmaceutical, biopharmaceutical or medical device industry with experience in technical writing.
● Technical expertise in small and large molecule drug substance and drug product manufacturing processes as well as associated control and documentation systems (e.g., MELODI, SAP, ValDam, Veeva).
● Experience with using quality-related tools, including Six Sigma / DMAIC, for problem solving and decision making.
● Experience collaborating in a global setting to support product teams and global quality initiatives.
● Experience with enterprise database, collaboration platforms, and analytics (IT platforms).
CEI: R2090154 | Licence No.: 22S1313
Lead Investigator, Global APQR & Complaint Operations
Job description:
A leading global life sciences company is looking for experienced and talented candidates for the position of Lead Investigator Global APQR & Complaint Operations based in South East Asia including Malaysia.
● Responsible for executing, reviewing and approving records in the Quality Management System (including Complaints, Global Change Control ownership, Discrepancy Investigations, CAPA, etc.).
● Identifies, analyzes, and drives the resolution of issues related to or identified with complaints processes.
● Provides training and guidance as needed regarding the complaints process, including planning and the implementation of procedures.
● Contributes to performance metrics and overall Quality assessment and reporting as part of the complaints business process.
● Lead product complaint investigations (critical and non-critical) with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards. Collaborate with departments (e.g. Affiliates, Manufacturing/Packaging Sites, Device Quality) to establish appropriate, efficient, and timely investigation strategies.
● Lead root cause analysis and present at QRB.
● Manage Global Complaints for Devices that were manufactured, packed, labeled and/or shipped by Commercial Supply or on behalf of Global Supply Chain.
● Initiate, coordinate, and track complaints as Lead Investigator or act as complaint QA and close/approve complaints.
Requirements:
● B.A., B.S. or Higher degree (preferably in Life Science)
● Minimum 6 years of releant experience in the pharmaceutical, biopharmaceutical or medical device industry with experience in technical writing.
● Technical expertise in small and large molecule drug substance and drug product manufacturing processes as well as associated control and documentation systems (e.g., MELODI, SAP, ValDam, Veeva).
● Experience with using quality-related tools, including Six Sigma / DMAIC, for problem solving and decision making.
● Experience collaborating in a global setting to support product teams and global quality initiatives.
● Experience with enterprise database, collaboration platforms, and analytics (IT platforms).
CEI: R2090154 | Licence No.: 22S1313
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