Experience+ AddGMP Compliance ManagerEditSANOFI PASTEUR LIMITEDJanuary 2015 - Present |Manager GMP Compliance is responsible for interfacing between Industrial Operations (IO) and Regulatory Affairs (RA) in order to ensure the smooth flow of information, accurate product license content, master documents and compliance to the GMPs. Ensures regulatory compliance for marketed products by a correct and timely handling of all regulatory activities related to his/her perimeter… Show more Experience+ AddGMP Compliance ManagerEditSANOFI PASTEUR LIMITEDJanuary 2015 - Present |Manager GMP Compliance is responsible for interfacing between Industrial Operations (IO) and Regulatory Affairs (RA) in order to ensure the smooth flow of information, accurate product license content, master documents and compliance to the GMPs. Ensures regulatory compliance for marketed products by a correct and timely handling of all regulatory activities related to his/her perimeter. The incumbent is also responsible for review of GMP regulations, guidances and industry trends and cascade information to stakeholders. • Review and approval of Master Product Specifications, Master BPRs, Site Reference File, Annual Reports, Submissions and Variations to ensure compliance to the License and GMP regulations. (40%)• Define and implement a process for assessment of conformance of master GMP documents against the license (license conformance) for all marketed products. Identify any gaps and communicate to the stakeholders for remediation. (20%)• Defines and implements a process for Quality Intelligence within IO. Assesses the impact of technical and GMP regulations, guidances, trends and communicates them internally. (20%)• Provides support during external inspections, global audits and/or third party audits. (10%)• Develops SOPs relative to processes and ways of working to support regulatory compliance. (10%) Show less

• Coordinate SAP-related activities for Quality Control Laboratories and maintain tracking of testing requirements in appropriate tools including LIMS• Run monthly reports for QC laboratories and customers to keep CM01 up to date• Assist with preparation of monthly meeting reports for QC capacity by providing data to QC Director and other stakeholders as requested• Coordinate Unplanned testing for QC labs• Tracking and reporting on QC metrics and QC Cycle Time • Manage… Show more • Coordinate SAP-related activities for Quality Control Laboratories and maintain tracking of testing requirements in appropriate tools including LIMS• Run monthly reports for QC laboratories and customers to keep CM01 up to date• Assist with preparation of monthly meeting reports for QC capacity by providing data to QC Director and other stakeholders as requested• Coordinate Unplanned testing for QC labs• Tracking and reporting on QC metrics and QC Cycle Time • Manage intersite testing requirements • Monitor Performance to identify Areas for Process Improvement • Review and maintain librarly of QC test Recipes/Standard Text keys and update as required based on revised capacity planning and resource adjustments• Provide OOS data for APQR• Manage changes in SAP recipes and Product Specifications for Change Controls• Participate in special projects as an SME for QC testing; Show less

• Responsible for the technical and industrial content (CMC and Establishment) of regulatory submissions for all products/projects• Responsible for the coordination and preparation of documents supporting product license activities (market authorization applications, variations/supplements, responses to questions, post-approval commitments and additional license-related activities).• Responsible for creation, maintenance, revision of Master Test Specifications for all products and… Show more • Responsible for the technical and industrial content (CMC and Establishment) of regulatory submissions for all products/projects• Responsible for the coordination and preparation of documents supporting product license activities (market authorization applications, variations/supplements, responses to questions, post-approval commitments and additional license-related activities).• Responsible for creation, maintenance, revision of Master Test Specifications for all products and substances• Cross-trained in Change Management and Batch Release activities to support other quality departments Show less

• Responsible for evaluation, investigation and response of customer complaints.• Responsible for performing Manufacturing Investigations required for Adverse Events.• Responsible for submitting Biological Product Deviation Reports (BPDRs) to RA regarding critical customer complaints received.

• Perform scientific and technical review of all product protocols prior to submission to regulatory agencies for release or release of product for distribution.• In absence act as designate or back up to department Manager.• Participate on Project Teams; Create Expiry Date Memos in SAP.• Responsible for evaluation, investigation and response of Quality Complaints.• Responsible for performing Manufacturing Investigations required for Adverse Events.

• Daily QC/QA functions includes co-ordination of master document updates, follow-up on product releases and communication with relevant contractors and departments.• Obtain production and quality control documentation from third party suppliers to ensure GMP compliance.• Investigate and maintain Product Complaint Reports ensuring compliance with GMP guidelines.• Maintain current printed packaging components for all product lines.• Maintain and update annual Establishment… Show more • Daily QC/QA functions includes co-ordination of master document updates, follow-up on product releases and communication with relevant contractors and departments.• Obtain production and quality control documentation from third party suppliers to ensure GMP compliance.• Investigate and maintain Product Complaint Reports ensuring compliance with GMP guidelines.• Maintain current printed packaging components for all product lines.• Maintain and update annual Establishment licenses.• Assist in ensuring clinical trials materials comply with GCP’s.• Assist in audits of suppliers, third party packagers, warehouses etc.• Develop relevant SOP’s and GMP contracts.• Responsible for notifying depots of Product Destruction required for all shortdated or damaged products. Show less

• Perform scientific and technical review of all product protocols prior to submission to regulatory agencies for release or release of product for distribution.• In absence (maternity leave), act as designate or back up to department Manager.• Participate on Project Teams.• Maintain database for calculation of Expiry Dates and Approval of Expiry Dates.• QA member of the SAP R/3 development and implementation team.

• Perform internal and external audits to ensure compliance with GMP/GLP standards and corporate policies.• Review of SOP’s and BPR documentation to ensure accuracy, concurrency, and compliance with GMP’s.• Training and supervision of other QA auditors in all Filling & Packaging (F&P) QA responsibilities.• Act as Manager of QA F&P Compliance in their absence.• Investigate process deviation reports and implement corrective actions with the F&P Department to prevent… Show more • Perform internal and external audits to ensure compliance with GMP/GLP standards and corporate policies.• Review of SOP’s and BPR documentation to ensure accuracy, concurrency, and compliance with GMP’s.• Training and supervision of other QA auditors in all Filling & Packaging (F&P) QA responsibilities.• Act as Manager of QA F&P Compliance in their absence.• Investigate process deviation reports and implement corrective actions with the F&P Department to prevent recurrence.• Participate in the development of Quality Policies, Specifications and Corporate Quality Improvements. Show less

• Act as a liaison between Merck-Frosst and Pasteur Merieux Connaught (PMC) to facilitate technology transfer and ensure compliance for licensure of the PMC facility.• Perform audits of vaccine manufacturing and test areas to ensure compliance with GMP standards and Corporate Quality Policies.• Evaluate and investigate process deviations or other quality deviations originating from the vaccine manufacturing and QC Testing Services.• Perform technical review of SOP’s, BRP’s… Show more • Act as a liaison between Merck-Frosst and Pasteur Merieux Connaught (PMC) to facilitate technology transfer and ensure compliance for licensure of the PMC facility.• Perform audits of vaccine manufacturing and test areas to ensure compliance with GMP standards and Corporate Quality Policies.• Evaluate and investigate process deviations or other quality deviations originating from the vaccine manufacturing and QC Testing Services.• Perform technical review of SOP’s, BRP’s, specifications and/or other documents that reflect operating parameters to ensure compliance to license, regulatory (GMP), and Corporate Quality requirements.• Participate and lead in problem solving teams comprised of Production and QC/QA team members.• Participate in the development and presentation of Training Programs.• Participate in the development of Quality Policies, Specifications, and Quality Improvements.• Act as a QA representative in the Production Area as part of a team to facilitate manufacturing operations. Show less

• Supervise and coordinate the daily activities of the QC Immunology Department.• Approval of test results and release of test protocols for products.• Develop and update SOP’s, Animal Use Protocols, and Test Procedures.• Responsible for coordinating and monitoring test development projects.• Responsible for coordinating training and providing guidance for staff.• Responsible for hiring and constructive discipline for all employees.• Participate in Performance review of… Show more • Supervise and coordinate the daily activities of the QC Immunology Department.• Approval of test results and release of test protocols for products.• Develop and update SOP’s, Animal Use Protocols, and Test Procedures.• Responsible for coordinating and monitoring test development projects.• Responsible for coordinating training and providing guidance for staff.• Responsible for hiring and constructive discipline for all employees.• Participate in Performance review of probation employees.• Assist in budget preparation, BRP and LINQ implementation.• Interacting with various departments such as QA, Protocol Administration, and Regulatory Affairs.• Participate in problem solving teams comprised of Production and QC/QA team members. Show less

• Field-testing and evaluation of insecticides for control of pests of livestock.• Responsible for the personal safety of individuals, part-time personnel, and animals treated with pesticides.• Insect colony maintenance.• Tabulating and analyzing data; developed lab manuals for entomology courses.• Assisting with extension and education programs involving pests of livestock and forestry.