Providing quality services for GMP pharmaceutical and Biotechnology industry. Completed assignments are as follows:

1 year and 2 months

Role: COMPLIANCE SPECIALIST (SENIOR TS)

Customer: Lonza Cell & Gene Therapy, NL

Key Responsibilities:

Quality Control & Microbiology Department

• Coordinate activities related to deviations, CAPAs, change controls and client audits between teams and stakeholders 
• Lead QC in audit preparation, discuss audit findings, define follow up actions with stakeholders, prepare response reports along with remediation actions 
• Manage indirect reports in investigation performance, CAPA and change implementation 
• Lead continuous improvement projects as part of site KPI and risk register 
• Manage OTC of QC related audit observations and quality events by liaising with stakeholders 
• Identify and assess risks in process, prepare risk assessments (FMEA, risk matrix) and mitigation plans 
• Prepare product impact assessments for major and critical deviations 
• Manage challenging, in-depth investigations using investigational tools 
• Investigate OOS/OOTs, review manufacturing investigations and prepare OOS investigation reports for stakeholders 
• Review stability and method SOPs to ensure compliance with Lonza /regulatory guidelines 
• Provide training and organize for cause trainings within QC 
• Ensure compliance with site quality KPIs and periodically present quality/performance metrics 

Key Accomplishments:

• Lead the quality event reduction project and brought the quality event overdues to zero by DEC 2021 
• Initiated overdue reduction action plan for 2022 and achieved the KPI targets for Q1 and Q2 
• Successful completion of defined quality actions for site inspection readiness and site risk register 
• Transfer of paper-based OOS system to electronic system via TrackWise 

9 months

Role: TECHNICAL SPECIALIST (SENIOR QC SPECIALIST)

Customer: Janssen Pharmaceuticals, J & J, NL

Key Responsibilities:

Quality Control for Supply Chain and New Product Introduction (NPI) support

• Collaborate with local/global NPI stakeholders for QC testing readiness and define timelines for deliverables 
• Lead 3 NPI projects for method transfer from different analytical development J&J sites to QC department 
• Analyze and update capacity planning including calculated hours required for validation and assay performance 
• Lead a team of QC associates and technicians, provide training and clear direction by setting expectations, deliverables due dates 
• Draft problem statement, process mapping and identifying process improvements 
• Prepare validation protocols, plan QC testing and share reports for NPIs with stakeholders 
• Create, review, and updates lab documentation and NPI supporting documents 
• Conduct risk assessment, impact assessment and gap analysis for QC/NPI processes 
• Responsible for deviation management, lead investigator for high impact deviations and defining CAPAs 
• Lead and drive continuous improvement projects such as non-conformance reduction and human error reduction   

Key Accomplishments:

• Successful technology transfer for 2 API-NPIs within QC bioassay 
• Developed detailed project schedules for planning testing and tracking equipments, analysts and materials capacity 
• Roll out non-conformance reduction strategies using DMAIC methodology 
• Implementation of human factor reduction cascade within QC bioassay 

Key Responsibilities:

• Oversee GMP bioanalytical testing for DS/DP, IPC and stability release 
• Technical review of testing results and preparing COAs for release 
• Lead and supervise QC technicians for DS/DP release testing and support problem solving 
• Analysis and trending of analytical data and reporting any trends or atypical results 
• Write and revise SOPs, draft plans and reports for assay qualification and validation for bioassays 
• Qualification and release of reference materials and critical reagents in bioassay testing 
• Investigate deviations, lab investigations, OOS/OOT and Root Cause Analysis through Quality tools 
• Implementing Corrective and Preventive Actions (CAPA) and change controls 
• Review and approve laboratory system validation and CSV reports 
• Implement Data integrity guidelines within QC and review audit trail reports 
• Lead continuous improvement projects in collaboration with stakeholders
• Oversee and coordinate lab equipment lifecycle management 
• Establishing GXP compliance and training QC personnel 
• Maintain strict compliance with QMS, GMP, GDP and safety regulations 

Key Accomplishments:

• Awarded Dynavax 2019 certificate of excellence for role in FDA audit readiness 
• Minimized human error root causes and reoccurring deviations 
• Implementing data integrity remediation and establishing audit trail SOP for QC lab systems 
• Supporting inspection readiness team for German health authority inspection and remediation activities  

Key Responsibilities:

• Develop Hematology controls and calibrators for hematology analyzers 
• Develop project plans and reports for release/stability studies 
• Monitor IPC and GMP release QC testing of Hematology products 
• Assess and troubleshoot product performance through the product lifecycle 
• QA support through OOS/OOT investigations, MR, CAPA and root cause analysis (RCA) 
• Create training material for new processes and measurement systems 
• Implement and train staff on QC processes and GMP guidelines 
• Plan and oversee lab related projects such as equipment qualification 
• Ensure documentation and compliance through DHF, gap analysis & remediation 
• Organize, communicate product updates and prepare department for internal and external audits

Key Accomplishments:

• Successful conversion of CDS Hematology controls, for all customers, from glass into PP vials 
• Completion of shipping stability studies on CDS calibrators for establishing shipping conditions

Key Responsibilities:

• Develop functional assay services for pharmaceutical and biotechnology clients
• Executed cellular assay optimization, qualification, and valid  
• Implemented cellular assays, biochemical and immunoassay techniques 
• Designed and executed cellular HTS and HCA/HCS for drug discovery projects 
• Developed assays for Operetta high-throughput imager, FLIPR HTS platform and flow cytometry platform for cell target identification 
• Documented SOPs, prepared presentations and demonstrated techniques to team members and stakeholders 
• Coordinated successfully with team members on internal and external projects 
• Accomplished long-term and short-term targets with full customer satisfaction

Key Accomplishment:

• Successful development and completion of high content screening of 50,000 compounds for identification of novel DNA repair inhibitors  

Key Responsibilities:

• Establish the isolations and quantification of murine Mesenchymal Stem Cells (mMSCs) using cell surface markers 
• Established flow cytometry protocols (FACS) for mMSC enrichme